ID

42716

Description

ATLAS ACS-TIMI 46 compared the safety and efficacy of rivaroxaban, an oral direct factor Xa inhibitor, to placebo in patients with acute coronary syndromes. This is an excerpt, empty itemgroups have been added to flag missing items.

Keywords

  1. 11/28/15 11/28/15 -
  2. 9/17/21 9/17/21 -
Copyright Holder

ATLAS ACS-TIMI 46 study group

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0

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Excerpt TIMI 46 Acute Coronary Syndrome NCT00402597

ATLAS ACS TIMI 46

  1. StudyEvent: ODM
    1. ATLAS ACS TIMI 46
Subject Identification
Description

Subject Identification

Subject Identifier
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials (first middle last)
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of Visit
Description

Date of Visit

Visit Date (ddmonyyyy)
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demographics
Description

Demographics

Date of Initial Informed Consent
Description

Date of Informed Consent

Data type

date

Alias
UMLS CUI [1]
C2985782
Date of Birth (dd- mon- yyyy)
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0150831
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
Inclusion/Exclusion Criteria
Description

Inclusion/Exclusion Criteria

Have all criteria listed in the protocol been met?
Description

Patient eligible

Data type

boolean

Alias
UMLS CUI [1]
C1302261
Criteria not met
Description

Criteria not met

Data type

text

Index ACS Event
Description

Index ACS Event

Onset date of index event
Description

Onset date of event

Data type

date

Alias
UMLS CUI [1]
C2985916
Onset time of index event
Description

Symptom onset time

Data type

time

Alias
UMLS CUI [1]
C1320528
Onset time of index event is unknown
Description

Onset time unknown

Data type

boolean

Cardiac ischemic symptoms >= 10 minutes at rest
Description

Cardiac ischemic symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0151744
Cardiac ischemic symptoms duration
Description

Cardiac ischemic symptoms duration

Data type

time

Alias
UMLS CUI [1,1]
C0436359
UMLS CUI [1,2]
C0151744
During 24 hours prior to Index Event, how many additional episodes of severe cardiac ischemic symptoms?
Description

Number of cardiac ischemic symptoms episodes

Data type

integer

Alias
UMLS CUI [1]
N
Date of hospital arrival for index event
Description

Date of hospital arrival for index event

Data type

date

Alias
UMLS CUI [1]
C1320532
Time of hospital arrival for index event
Description

Time of hospital arrival for index event

Data type

time

Alias
UMLS CUI [1]
C1320532
Time of hospital arrival for index event is unknown
Description

Time of hospital arrival unknown

Data type

boolean

Index Event Diagnosis
Description

Working diagnosis

Data type

text

Alias
UMLS CUI [1]
C0332135
If 'STEMI', was fibrinolytic therapy given?
Description

Thrombolytic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0040044
Fibrinolytic therapy start time
Description

Thrombolytic therapy start time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0040044
Time therapy started is unknown
Description

Time therapy started is unknown

Data type

boolean

Was this an anterior STEMI?
Description

Anterior STEMI

Data type

boolean

Alias
UMLS CUI [1]
C2882090
Elevated cardiac enzyme marker
Description

Elevated enzymes increased

Data type

boolean

Alias
UMLS CUI [1]
C0741921
>= 1 mm ST deviation
Description

ST deviation

Data type

boolean

Alias
UMLS CUI [1]
C1116089
TIMI risk score >= 3
Description

TIMI risk score

Data type

boolean

Alias
UMLS CUI [1]
C3272266
Killip class
Description

Killip class

Data type

text

Alias
UMLS CUI [1]
C1881332
Left Ventricular Function Assessment
Description

Left Ventricular Ejection Fraction

Data type

text

Alias
UMLS CUI [1]
C0428772
Heart Rate (beats/min)
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure (mmHg)
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure (mmHg)
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Date of index event ECG
Description

Date of index event ECG

Data type

date

Alias
UMLS CUI [1]
C2826846
Time of index event ECG
Description

Time of index event ECG

Data type

time

Alias
UMLS CUI [1]
C2826846
Time of index event ECG is unknown
Description

Time of index event ECG is unknown

Data type

boolean

New persistent ST elevation >= 1 mm
Description

Persistent ST elevation

Data type

boolean

Alias
UMLS CUI [1]
C2216134|C0520886
New transient ST elevation >= 1 mm
Description

Transient ST elevation

Data type

boolean

Alias
UMLS CUI [1]
C0520886
New significant Q wave
Description

Q wave

Data type

boolean

Alias
UMLS CUI [1]
C1305738
New ST depression >= 1 mm
Description

ST depression

Data type

boolean

Alias
UMLS CUI [1]
C0520887
New ST depression between 0.5 mm and 1 mm
Description

ST depression

Data type

boolean

Alias
UMLS CUI [1]
C0520887
New non-specific ST or T wave changes
Description

ST or T wave changes

Data type

boolean

Alias
UMLS CUI [1]
C1112720
New left bundle branch block
Description

Left bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0023211
No new changes but abnormal
Description

ECG abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
Normal
Description

ECG Normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Lab Test Name
Description

Lab Test Name

Data type

text

Date of sample collection
Description

Date of sample collection

Data type

date

Alias
UMLS CUI [1]
N
Time of sample collection (24 hour clock)
Description

Time of sample collection

Data type

time

Alias
UMLS CUI [1]
N
Time of sample collection is unknown
Description

Time of sample collection is unknown

Data type

boolean

Numeric Result
Description

Numeric Result

Data type

boolean

Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Upper Limit of Normal(ULN)
Description

Upper Limit of Normal(ULN)

Data type

float

Alias
UMLS CUI [1]
C1519815
x ULN or Positive/Negative
Description

x ULN or Positive/Negative

Data type

text

Hospital Discharge for Index Event
Description

Hospital Discharge for Index Event

Date of hospital discharge for index event
Description

Date of discharge

Data type

date

Alias
UMLS CUI [1]
C2361123
Time of hospital discharge for index event
Description

Time of discharge

Data type

time

Alias
UMLS CUI [1]
C3864299
Time of hospital discharge for index event is unknown
Description

Time of hospital discharge unknown

Data type

boolean

Medical History of Special Interest
Description

Medical History of Special Interest

Previous Myocardial Infarction
Description

Prior MI

Data type

boolean

Alias
UMLS CUI [1]
C1275835
Most recent onset date prior to event admission
Description

Date of MI

Data type

date

Alias
UMLS CUI [1]
C2924287
Angina
Description

Angina pectoris

Data type

boolean

Alias
UMLS CUI [1]
C0002962
Most recent onset date prior to event admission
Description

Angina onset date

Data type

date

Alias
UMLS CUI [1]
C2984181
If 'Yes', Canadian Classification at 1 month prior to admission
Description

Canadian Classification

Data type

text

Alias
UMLS CUI [1]
C1277207
Coronary Artery Disease with Stenosis >= 50%
Description

Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
Most recent onset date prior to event admission
Description

Onset of coronary heart disease

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1956346
Family History of Coronary Heart Disease
Description

Family History of Coronary Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C2317524
Congestive Heart Disease
Description

Congestive Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018802
Most recent onset date prior to event admission
Description

Congestive heart disease onset date

Data type

date

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0574845
Atrial Fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
Most recent onset date prior to event admission
Description

Atrial fibrillation onset date

Data type

date

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0574845
Percutaneous Coronary Intervention
Description

Prior PCI

Data type

boolean

Alias
UMLS CUI [1]
C1320647
Most recent onset date prior to event admission
Description

Date of prior PCI

Data type

date

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C1532338
Coronary Artery Bypass Graft Surgery
Description

CABG

Data type

boolean

Alias
UMLS CUI [1]
C0010055
Most recent onset date prior to event admission
Description

Date of CABG

Data type

date

Alias
UMLS CUI [1]
C2164190
Diabetes Mellitus
Description

Diabetes Mellitus

Data type

text

Alias
UMLS CUI [1]
C0011849
Hypertension Requiring Medical Therapy
Description

Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
Valvular Heart Disease
Description

Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
Hypercholesterolemia Requiring Medical Therapy
Description

Hypercholesterolemia

Data type

boolean

Alias
UMLS CUI [1]
C0020443
Cigarette Smoking
Description

Tobacco use

Data type

text

Alias
UMLS CUI [1]
C0543414
Alcohol Consumption
Description

Alcohol Consumption

Data type

text

Alias
UMLS CUI [1]
C0001948
Peripheral Arterial Disease
Description

Peripheral Arterial Disease

Data type

boolean

Alias
UMLS CUI [1]
C0085096
Stroke
Description

Stroke

Data type

boolean

Alias
UMLS CUI [1]
C0038454
Most recent onset date prior to event admission
Description

Stroke date

Data type

date

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0011008
Transient Ischemic Attack
Description

Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0007787
Most recent onset date prior to event admission
Description

TIA date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0007787
Known Carotid Stenosis (>=50%)
Description

Carotid Stenosis

Data type

text

Alias
UMLS CUI [1]
C0007282
Most recent onset date prior to event admission
Description

Date of carotid stenosis

Data type

date

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0011008
Liver Disease
Description

Liver Disease

Data type

boolean

Alias
UMLS CUI [1]
C0085605
Most recent onset date prior to event admission
Description

Liver disease date

Data type

date

Alias
UMLS CUI [1,1]
C0085605
UMLS CUI [1,2]
C0011008
Peptic Ulcer Disease
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
Most recent onset date prior to event admission
Description

Date of Peptic Ulcer

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030920
Gastrointestinal Bleeding
Description

Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0017181
Most recent onset date prior to event admission
Description

Date of gastrointestinal hemorrhage

Data type

date

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C0011008
Chronic Renal Insufficiency
Description

Chronic Kidney Failure

Data type

boolean

Alias
UMLS CUI [1]
C0022661
Vital Signs at Screening
Description

Vital Signs at Screening

Weight
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Height
Description

Height

Data type

float

Alias
UMLS CUI [1]
C0005890
Waist Circumference
Description

Waist Circumference

Data type

float

Alias
UMLS CUI [1]
C0455829
Heart Rate (beats/min)
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic Blood Pressure (mmHg)
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure (mmHg)
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Vital Signs
Description

Vital Signs

Heart Rate (beats/min)
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic Blood Pressure (mmHg)
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure (mmHg)
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Study Medication Review
Description

Study Medication Review

First Dose of Study Medication
Description

First Dose of Study Medication

Date of first dose
Description

Date of first dose

Data type

date

Alias
UMLS CUI [1]
C3173309
Time of first dose
Description

Time of first dose

Data type

time

Time of first dose is unknown
Description

Time of first dose is unknown

Data type

boolean

Concomitant Therapy
Description

Concomitant Therapy

Aspirin Concomitant Therapy
Description

Aspirin Concomitant Therapy

Alias
UMLS CUI-1
C0004057
Total daily dose
Description

Aspirin dose

Data type

integer

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
Start Date
Description

Aspirin Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0004057
Start Time
Description

Aspirin Start Time

Data type

time

Start time is unknown
Description

Start time is unknown

Data type

boolean

Prior to Study Entry?
Description

Prior to Study Entry?

Data type

text

Stop Date
Description

Aspirin Stop Date

Data type

text

Stop Time
Description

Aspirin Stop Time

Data type

text

Stop time is unknown
Description

Stop time is unknown

Data type

text

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

text

Thienopyridine Concomitant Therapy
Description

Thienopyridine Concomitant Therapy

Alias
UMLS CUI-1
C2936588
Reported Name of Drug, Med or Therapy
Description

Reported Name of Drug, Med or Therapy

Data type

text

Total daily dose
Description

Thienopyridine dose

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2936588
Prior to Study Entry?
Description

Prior to Study Entry?

Data type

boolean

Start Date
Description

Thienopyridine Start Date

Data type

text

Alias
UMLS CUI [1,1]
C2936588
UMLS CUI [1,2]
C1301880
Start Time
Description

Thienopyridine Start Time

Data type

time

Start Time is unknown
Description

Start Time is unknown

Data type

boolean

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

boolean

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

Stop Time is unknown
Description

Stop Time is unknown

Data type

boolean

Unfractionated Heparin
Description

Unfractionated Heparin

Alias
UMLS CUI-1
C2825026
Total daily dose
Description

Unfractionated Heparin dose

Data type

text

Alias
UMLS CUI [1,1]
C2825026
UMLS CUI [1,2]
C0178602
Prior to Study Entry?
Description

Prior to Study Entry?

Data type

boolean

Start Date
Description

Unfractionated Heparin Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2825026
Start Time
Description

Unfractionated Heparin Start Time

Data type

time

Start Time is unknown
Description

Start Time is unknown

Data type

boolean

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

boolean

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

Stop Time is unknown
Description

Stop Time is unknown

Data type

boolean

Low Molecular Weight Heparin
Description

Low Molecular Weight Heparin

Alias
UMLS CUI-1
C0019139
Reported Name of Drug, Med or Therapy
Description

Reported Name of Drug, Med or Therapy

Data type

text

Total Daily Dose
Description

LMWH dose

Data type

text

Alias
UMLS CUI [1,1]
C3536766
UMLS CUI [1,2]
C0178602
Prior to Study Entry?
Description

Prior to Study Entry?

Data type

boolean

Start Date
Description

LMWH Start Date

Data type

date

Alias
UMLS CUI [1,1]
C3536766
UMLS CUI [1,2]
C1301880
Start Time
Description

LMWH Start Time

Data type

time

Start Time is unknown
Description

Start Time is unknown

Data type

boolean

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

boolean

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

End Time is unknown
Description

End Time is unknown

Data type

boolean

Other Parenteral Anticoagulant
Description

Other Parenteral Anticoagulant

Alias
UMLS CUI-1
C3536847
Reported Name of Drug, Med or Therapy
Description

Reported Name of Drug, Med or Therapy

Data type

text

Total Daily Dose
Description

Anticoagulant dose

Data type

text

Alias
UMLS CUI [1,1]
C3536847
UMLS CUI [1,2]
C0178602
Prior to Study Entry?
Description

Prior to Study Entry?

Data type

boolean

Start Date
Description

Anticoagulant Start Date

Data type

date

Alias
UMLS CUI [1,1]
C3536847
UMLS CUI [1,2]
C0808070
Start Time
Description

Anticoagulant Start Time

Data type

time

Start Time is unknown
Description

Start Time is unknown

Data type

boolean

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

boolean

Stop Date
Description

Anticoagulant Stop Date

Data type

date

Stop Time
Description

Anticoagulant Stop Time

Data type

time

Stop Time is unknown
Description

Stop Time is unknown

Data type

boolean

Oral Anticoagulant
Description

Oral Anticoagulant

Alias
UMLS CUI-1
C0354604
Reported Name of Drug, Med or Therapy
Description

Reported Name of Drug, Med or Therapy

Data type

text

Total Daily Dose
Description

Oral Anticoagulant dose

Data type

text

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C0178602
Prior to Study Entry?
Description

Prior to Study Entry?

Data type

boolean

Start Date
Description

Oral Anticoagulant Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C0808070
Start Time
Description

Oral Anticoagulant Start Time

Data type

time

Start Time is unknown
Description

Start Time is unknown

Data type

boolean

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

boolean

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

Stop Time is unknown
Description

Stop Time is unknown

Data type

boolean

Glycoprotein IIb/IIIa Inhibitor
Description

Glycoprotein IIb/IIIa Inhibitor

Alias
UMLS CUI-1
C3640054
Reported Name of Drug, Med or Therapy
Description

Reported Name of Drug, Med or Therapy

Data type

text

Total Daily Dose
Description

GP IIb/IIIa inhibitor dose

Data type

text

Alias
UMLS CUI [1,1]
C3640054
UMLS CUI [1,2]
C0178602
Prior to Study Entry?
Description

Prior to Study Entry?

Data type

boolean

Start Date
Description

GP IIb/IIIa inhibitor Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1301880
Start Time
Description

GP IIb/IIIa inhibitor Start Time

Data type

time

Start Time Unknown
Description

Start Time Unknown

Data type

boolean

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

boolean

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

Stop Time Unknown
Description

Stop Time Unknown

Data type

boolean

Fibrinolytic
Description

Fibrinolytic

Alias
UMLS CUI-1
C0040044
Reported Name of Drug, Med or Therapy
Description

Reported Name of Drug, Med or Therapy

Data type

text

Total Daily Dose
Description

Fibrinolytic dose

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040044
Prior to Study Entry?
Description

Prior to Study Entry?

Data type

boolean

Start Date
Description

Fibrinolytic start date

Data type

date

Alias
UMLS CUI [1,1]
C0040044
UMLS CUI [1,2]
C1301880
Start time
Description

Fibrinolytic start time

Data type

time

Start Time is unknown
Description

Start Time is unknown

Data type

boolean

Ongoing at Study End?
Description

Ongoing at Study End?

Data type

boolean

Stop Date
Description

Fibrinolytic Stop Date

Data type

date

Stop Time
Description

Fibrinolytic Stop Time

Data type

time

Stop time is unknown
Description

Stop time is unknown

Data type

boolean

ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
Date of ECG
Description

ECG date

Data type

date

Alias
UMLS CUI [1]
C2826846
Time of ECG
Description

Time of ECG

Data type

time

Time of ECG is unknown
Description

Time of ECG is unknown

Data type

boolean

Unscheduled ECG
Description

Unscheduled ECG

DNA Sample
Description

DNA Sample

DNA Sample Consent Modification
Description

DNA Sample Consent Modification

DNA Sample Replacement
Description

DNA Sample Replacement

Neurological Exam/Modified Rankin Scale
Description

Neurological Exam/Modified Rankin Scale

Seattle Angina Questionnaire (Question 1)
Description

Seattle Angina Questionnaire (Question 1)

Echocardiogram
Description

Echocardiogram

Alias
UMLS CUI-1
C0013516
Accession number
Description

Accession number

Data type

text

Date of Echocardiogram
Description

Date of Echocardiogram

Data type

date

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0011008
Time of Echocardiogram
Description

Time of Echocardiogram

Data type

time

Time of Echocardiogram is unknown
Description

Time of Echocardiogram is unknown

Data type

boolean

High Frequency Probe Used?
Description

High Frequency Probe Used?

Data type

boolean

Alias
UMLS CUI [1]
N
LV Thrombis Present or Absent?
Description

Left ventricular thrombus

Data type

boolean

Alias
UMLS CUI [1]
C0587044
Ejection Fraction
Description

Ejection Fraction

Data type

text

Alias
UMLS CUI [1]
C0232174
Holter
Description

Holter

Medication Kit Number
Description

Medication Kit Number

Central Lab Sample Collection
Description

Central Lab Sample Collection

PK/PD Sample Collection
Description

PK/PD Sample Collection

End of Screening / Randomization
Description

End of Screening / Randomization

Did subject complete the screening period including randomization?
Description

Did subject complete the screening period including randomization?

Data type

boolean

Randomization Number
Description

Randomization Number

Data type

text

Primary reason for premature termination
Description

Primary reason for premature termination

Data type

text

Alias
UMLS CUI [1]
C2348570
End of Treatment / Early Withdrawal
Description

End of Treatment / Early Withdrawal

Did subject complete a double-blind treatment period?
Description

Did subject complete a double-blind treatment period?

Data type

boolean

Date of last dose
Description

Date of last dose

Data type

date

Alias
UMLS CUI [1]
C1762893
Time of last dose
Description

Time of last dose

Data type

time

Time of last dose is unknown
Description

Time of last dose is unknown

Data type

time

Primary reason for premature termination
Description

Primary reason for premature termination

Data type

text

Alias
UMLS CUI [1]
C2348570
End of Follow-up
Description

End of Follow-up

Alias
UMLS CUI-1
C0589120
Did the subject complete follow-up period
Description

Did the subject complete follow-up period

Data type

boolean

Alias
UMLS CUI [1]
C0589120
Date of final contact
Description

Date of final contact

Data type

date

Alias
UMLS CUI [1]
C0805839
If 'Not complete follow-up period' indicate reason
Description

If 'Not complete follow-up period' indicate reason

Data type

text

CEC Adjudicated Form
Description

CEC Adjudicated Form

DEATH
Description

Death

Data type

text

Alias
UMLS CUI [1]
C1306577
MIOCARDIAL INFARCTION
Description

Myocardial Infarction

Data type

text

Alias
UMLS CUI [1]
C0027051
MI Sub-category
Description

MI Sub-category

Data type

text

STROKE
Description

Stroke

Data type

text

Alias
UMLS CUI [1]
C0038454
RECURRENT ISCHEMIA
Description

Myocardial ischemia

Data type

text

Alias
UMLS CUI [1]
C0151744
NON-CNS SYSTEMIC EMBOLISM
Description

Embolism

Data type

text

Alias
UMLS CUI [1]
C0013922
BLEEDING EVENTS
Description

Hemorrhage

Data type

text

Alias
UMLS CUI [1]
C0019080
Death Adjudication
Description

Death Adjudication

Myocardial Infarction and Recurrent Ischemia Adjudication
Description

Myocardial Infarction and Recurrent Ischemia Adjudication

MI (not within 72 hours of index event or following PCI/CABG):
Description

Myocardial infarction

Data type

text

Alias
UMLS CUI [1]
C0027051
Troponin or CK-MB > ULN
Description

Troponin or CK-MB

Data type

text

Alias
UMLS CUI [1]
C0523584|C0523952
ECG evidence of new Q waves
Description

Q waves

Data type

text

Alias
UMLS CUI [1]
C1305738
MI within the first 72 hours after the index MI
Description

Myocardial Infarction

Data type

text

Alias
UMLS CUI [1]
C0027051
Re-elevation of the troponin or CK-MB > ULN and increased by at least 50% over the previous value, which was stable or decreasing (if not available, CK > 2 times ULN and increased by at least 50% over the previous value, which was stable or decreasing )
Description

Troponin or CK-MB

Data type

text

Alias
UMLS CUI [1]
C0523584|C0523952
Following PCI, CK-MB (or CK ) > 3 times ULN and increased by at least 50% over the previous value, which was stable or decreasing
Description

CK-MB

Data type

text

Alias
UMLS CUI [1]
C0523584
ECG evidence of new Q waves
Description

Q wave

Data type

text

Alias
UMLS CUI [1]
C1305738
MI within 24 hours after PCI (not within 72 hours of the index event):
Description

Myocardial Infarction

Data type

text

Alias
UMLS CUI [1]
C0027051
CK-MB (or CK) > 3 times ULN and if the pre-PCI level > ULN, then increased by at least 50% over the previous value, which was stable or decreasing)
Description

CK-MB

Data type

text

Alias
UMLS CUI [1]
C0523584
Severe Recurrent Ischemia Adjudication
Description

Severe Recurrent Ischemia Adjudication

New ischemic ECG changes (i.e., ST-segment elevation or depression or T wave inversion in at least 2 adjacent leads)
Description

ECG signs of myocardial ischaemia

Data type

text

Alias
UMLS CUI [1]
C1141959
Increase in CK-MB not meeting criteria for MI
Description

CK-MB

Data type

text

Alias
UMLS CUI [1]
C0523584
Need for unplanned coronary angiography, PCI, or CABG
Description

Coronary angiography, PCI, or CABG

Data type

text

Alias
UMLS CUI [1]
C0085532|C1532338|C0010055
Stroke Adjudication
Description

Stroke Adjudication

NON-CNS Systemic Embolization Adjudication
Description

NON-CNS Systemic Embolization Adjudication

Clinically Significant Bleeding Event Adjudication Form
Description

Clinically Significant Bleeding Event Adjudication Form

Stent Thrombosis Adjudication
Description

Stent Thrombosis Adjudication

Canadian Cardiovascular Society Classification of Angina
Description

Canadian Cardiovascular Society Classification of Angina

Canadian Cardiovascular Society Classification of Angina
Description

Canadian Cardiovascular Society Classification of Angina

Data type

text

Alias
UMLS CUI [1]
C1879987
Events and Procedures Review
Description

Events and Procedures Review

Death
Description

Death

Data type

boolean

Alias
UMLS CUI [1]
C1306577
Cardiac Ischemic Event
Description

Myocardial Ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0151744
Coronary Revascularization
Description

Coronary Revascularization

Data type

text

Alias
UMLS CUI [1]
C0877341
Stroke / TIA
Description

Stroke

Data type

boolean

Alias
UMLS CUI [1]
C0038454
Bleeding Event
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
Non-CNS Systemic Embolization
Description

Embolization

Data type

boolean

Alias
UMLS CUI [1]
C0013931
Adverse Event
Description

Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Stress Test
Description

Stress Test

Data type

boolean

Alias
UMLS CUI [1]
C1384495
Echocardiography
Description

Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0013516
Radionucleotide Angiography
Description

Radionucleotide Angiography

Data type

boolean

Alias
UMLS CUI [1]
C3865861
Pacemaker
Description

Cardiac Pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0030163
Intracardiac Defibrillator
Description

Cardiac Defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C1273352
Intra-aortic Balloon Pump
Description

Intra-aortic Balloon Pump

Data type

boolean

Alias
UMLS CUI [1]
C0021860
Left Ventricular Assist Device
Description

Left Ventricular Assist Device

Data type

boolean

Alias
UMLS CUI [1]
C0181598
Electrophysiology Study
Description

Electrophysiology Study

Data type

boolean

Alias
UMLS CUI [1]
C1446476
Unplanned Holter Monitor
Description

Holter Electrocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0013801
Pulmonary Artery Catheter
Description

Pulmonary Artery Catheter

Data type

boolean

Alias
UMLS CUI [1]
C0190658
Ventilator
Description

Ventilator

Data type

boolean

Alias
UMLS CUI [1]
C0087153
Ventilation/Perfusion Scan
Description

Ventilation/Perfusion Scan

Data type

boolean

Alias
UMLS CUI [1]
C0560738
Pulmonary Angiography
Description

Pulmonary Angiography

Data type

boolean

Alias
UMLS CUI [1]
C0677490
CT or MRI Imaging
Description

CT or MRI Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0024485|C0040405
Coronary Angiography
Description

Coronary Angiography

Data type

boolean

Alias
UMLS CUI [1]
C0085532
Percutaneous Peripheral Vascular Intervention
Description

Percutaneous Peripheral Vascular Intervention

Data type

boolean

Alias
UMLS CUI [1]
C2609295
Percutaneous Cerebrovascular Intervention
Description

Percutaneous Cerebrovascular Intervention

Data type

boolean

Alias
UMLS CUI [1]
N
Surgical Procedure (other than CABG)
Description

Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1]
C0543467
Other
Description

Other

Data type

boolean

Death
Description

Death

Event Unique Identifier
Description

Event Unique Identifier

Data type

text

Date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Time of death
Description

Time of death

Data type

time

Alias
UMLS CUI [1]
C1301931
Autopsy performed
Description

Autopsy performed

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Death witnessed
Description

Death witnessed

Data type

boolean

Alias
UMLS CUI [1]
C2924291
Cause of death
Description

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
Cardiac Ischemic Events
Description

Cardiac Ischemic Events

Event Unique Identifier
Description

Event Unique Identifier

Data type

text

Cardiac Ischemic Event
Description

Myocardial Ischemia

Data type

text

Alias
UMLS CUI [1]
C0151744
New persistent ST elevation >= 1 mm
Description

ST elevation

Data type

text

Alias
UMLS CUI [1]
C0520886
New transient ST elevation >=1 mm
Description

ST elevation

Data type

text

Alias
UMLS CUI [1]
C0520886
New significant Q wave
Description

Q wave

Data type

text

Alias
UMLS CUI [1]
C1305738
New ST depression >= 1 mm
Description

ST depression

Data type

text

Alias
UMLS CUI [1]
C0520887
New ST depression >= 0.5 to 1 mm
Description

ST depression

Data type

text

Alias
UMLS CUI [1]
C0520887
New non-specific ST or T wave changes
Description

on-specific ST or T wave changes

Data type

text

Alias
UMLS CUI [1]
C1112720
New left bundle branch block
Description

Left bundle branch block

Data type

text

Alias
UMLS CUI [1]
C0023211
No new changes but abnormal
Description

ECG abnormal

Data type

text

Alias
UMLS CUI [1]
C0522055
Normal
Description

ECG normal

Data type

text

Alias
UMLS CUI [1]
C0522054
Coronary Revascularization
Description

Coronary Revascularization

Alias
UMLS CUI-1
C0877341
Date of Coronary Revascularization
Description

Date of Coronary Revascularization

Data type

date

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0011008
Did subject undergo CABG?
Description

CABG

Data type

boolean

Alias
UMLS CUI [1]
C0010055
Lesion number
Description

Lesion number

Data type

integer

Alias
UMLS CUI [1]
C0449791
Site of Lesion
Description

Site of Lesion

Data type

text

Alias
UMLS CUI [1]
C0449695
Graft Type
Description

Graft Type

Data type

text

Alias
UMLS CUI [1]
C0449494
Graft Location
Description

Graft Location

Data type

text

Alias
UMLS CUI [1]
N
Culprit Lesion?
Description

Culprit Lesion

Data type

text

Alias
UMLS CUI [1]
C1299364
Total Stent Length
Description

Stent Length

Data type

text

Alias
UMLS CUI [1]
C0449462
Stent size
Description

Stent size

Data type

text

Alias
UMLS CUI [1]
N
Device used
Description

Device used

Data type

text

Alias
UMLS CUI [1]
N
Coronary Revascularization Prior to Signed Informed Consent
Description

Coronary Revascularization Prior to Signed Informed Consent

Local Cardiac Biomarker Measurements
Description

Local Cardiac Biomarker Measurements

Alias
UMLS CUI-1
C1271630
Lab Test Name
Description

Lab Test Name

Data type

text

Blood Transfusion
Description

Blood Transfusion

Alias
UMLS CUI-1
C0005841
Stroke/TIA Events
Description

Stroke/TIA Events

Event Unique Identifier
Description

Event Unique Identifier

Data type

text

Stroke / TIA Event
Description

Stroke

Data type

text

Alias
UMLS CUI [1]
C0038454
Start Date
Description

Stroke date

Data type

date

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0011008
Bleeding Events
Description

Bleeding Events

Alias
UMLS CUI-1
C0019080
Event Unique Identifier
Description

Event Unique Identifier

Data type

text

Bleeding Event
Description

Hemorrhage

Data type

text

Alias
UMLS CUI [1]
C0019080
Start date of bleeding event
Description

Date of hemorrhage

Data type

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0011008
Primary location of bleeding
Description

Bleeding location

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0450429
Local Hematology Measurements
Description

Local Hematology Measurements

Lab Test Name
Description

Lab Test Name

Data type

text

Non-CNS Systemic Embolization Events
Description

Non-CNS Systemic Embolization Events

Other Adverse Events
Description

Other Adverse Events

Local Lab
Description

Local Lab

Date of Sample Collection
Description

Date of Sample Collection

Data type

date

Alias
UMLS CUI [1]
C1549498
Lab Test Name
Description

Lab Test Name

Data type

text

Numeric Result
Description

Numeric Result

Data type

text

Health Resource Utilization Review
Description

Health Resource Utilization Review

Emergency Room Visit
Description

Emergency Room

Data type

boolean

Alias
UMLS CUI [1]
C0583237
Hospitalization
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
Urgent Care or Physician Office Visit
Description

Urgent Care or Physician Office Visit

Data type

boolean

Alias
UMLS CUI [1]
C1551285
Skilled Nursing / Rehabilitation Facility
Description

Skilled Nursing / Rehabilitation Facility

Data type

boolean

Alias
UMLS CUI [1]
C0037265
Rehabilitation (Outpatient)
Description

Rehabilitation

Data type

boolean

Alias
UMLS CUI [1]
C0034991
Home Care Visit
Description

Home Care

Data type

boolean

Alias
UMLS CUI [1]
C0204977
Emergency Room Visits
Description

Emergency Room Visits

Hospitalization
Description

Hospitalization

Hospital Admission Date
Description

Hospital Admission Date

Data type

date

Alias
UMLS CUI [1]
C0806429
Hospital Discharge Date
Description

Hospital Discharge Date

Data type

date

Alias
UMLS CUI [1]
C2361123
Type of Hospital
Description

Type of Hospital

Data type

text

Alias
UMLS CUI [1]
N
Type of Admission
Description

Type of Admission

Data type

text

Alias
UMLS CUI [1]
C1550330
Type of Unit or Ward
Description

Type of Unit or Ward

Data type

text

Alias
UMLS CUI [1]
N
Reason Type
Description

Reason type for admission

Data type

text

Alias
UMLS CUI [1]
N
Primary Reason for Hospitalization
Description

Primary Reason for Hospitalization

Data type

text

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0392360
Urgent Care or Physician Office Visit
Description

Urgent Care or Physician Office Visit

Skilled Nursing/Rehabilitation Facility
Description

Skilled Nursing/Rehabilitation Facility

Rehabilitation (Outpatient)
Description

Rehabilitation (Outpatient)

Home Care Visits
Description

Home Care Visits

Investigator Signature
Description

Investigator Signature

I have verified the data entries for this subject and have determined that they are complete, accurate, and in accordance with source documents.
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316

Similar models

ATLAS ACS TIMI 46

  1. StudyEvent: ODM
    1. ATLAS ACS TIMI 46
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Identification
Patient ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Subject Initials (first middle last)
text
C2986440 (UMLS CUI [1])
Item Group
Date of Visit
Visit Date
Item
Visit Date (ddmonyyyy)
date
C1320303 (UMLS CUI [1])
Item Group
Demographics
Date of Informed Consent
Item
Date of Initial Informed Consent
date
C2985782 (UMLS CUI [1])
Date of Birth
Item
Date of Birth (dd- mon- yyyy)
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0150831 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
American Indian or Alaska Native (4)
CL Item
Native Hawaiian or Pacific Native (5)
CL Item
Other (6)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not hispanic or Latino (2)
Item Group
Inclusion/Exclusion Criteria
Patient eligible
Item
Have all criteria listed in the protocol been met?
boolean
C1302261 (UMLS CUI [1])
Criteria not met
Item
Criteria not met
text
Item Group
Index ACS Event
Onset date of event
Item
Onset date of index event
date
C2985916 (UMLS CUI [1])
Symptom onset time
Item
Onset time of index event
time
C1320528 (UMLS CUI [1])
Onset time unknown
Item
Onset time of index event is unknown
boolean
Cardiac ischemic symptoms
Item
Cardiac ischemic symptoms >= 10 minutes at rest
boolean
C0151744 (UMLS CUI [1])
Cardiac ischemic symptoms duration
Item
Cardiac ischemic symptoms duration
time
C0436359 (UMLS CUI [1,1])
C0151744 (UMLS CUI [1,2])
Number of cardiac ischemic symptoms episodes
Item
During 24 hours prior to Index Event, how many additional episodes of severe cardiac ischemic symptoms?
integer
N (UMLS CUI [1])
Date of hospital arrival for index event
Item
Date of hospital arrival for index event
date
C1320532 (UMLS CUI [1])
Time of hospital arrival for index event
Item
Time of hospital arrival for index event
time
C1320532 (UMLS CUI [1])
Time of hospital arrival unknown
Item
Time of hospital arrival for index event is unknown
boolean
Item
Index Event Diagnosis
text
C0332135 (UMLS CUI [1])
Code List
Index Event Diagnosis
CL Item
STEMI (1)
C1536220 (UMLS CUI-1)
CL Item
NSTEMI (2)
C3537184 (UMLS CUI-1)
CL Item
Unstable Angina (3)
C0002965 (UMLS CUI-1)
Thrombolytic therapy
Item
If 'STEMI', was fibrinolytic therapy given?
boolean
C0040044 (UMLS CUI [1])
Thrombolytic therapy start time
Item
Fibrinolytic therapy start time
time
C1301880 (UMLS CUI [1,1])
C0040044 (UMLS CUI [1,2])
Time therapy started is unknown
Item
Time therapy started is unknown
boolean
Anterior STEMI
Item
Was this an anterior STEMI?
boolean
C2882090 (UMLS CUI [1])
Elevated enzymes increased
Item
Elevated cardiac enzyme marker
boolean
C0741921 (UMLS CUI [1])
ST deviation
Item
>= 1 mm ST deviation
boolean
C1116089 (UMLS CUI [1])
TIMI risk score
Item
TIMI risk score >= 3
boolean
C3272266 (UMLS CUI [1])
Item
Killip class
text
C1881332 (UMLS CUI [1])
Code List
Killip class
CL Item
I (1)
I (UMLS CUI-1)
CL Item
II (2)
I (UMLS CUI-1)
CL Item
III (3)
I (UMLS CUI-1)
CL Item
IV (4)
I (UMLS CUI-1)
CL Item
Unknwon (5)
I (UMLS CUI-1)
Item
Left Ventricular Function Assessment
text
C0428772 (UMLS CUI [1])
Code List
Left Ventricular Function Assessment
CL Item
Normal (1)
I (UMLS CUI-1)
CL Item
Mild dysfunction (2)
I (UMLS CUI-1)
CL Item
Moderate dysfunction (3)
I (UMLS CUI-1)
CL Item
Severe Dysfunction (4)
I (UMLS CUI-1)
CL Item
Unknown (6)
I (UMLS CUI-1)
Heart Rate
Item
Heart Rate (beats/min)
integer
C0018810 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure (mmHg)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure (mmHg)
integer
C0428883 (UMLS CUI [1])
Date of index event ECG
Item
Date of index event ECG
date
C2826846 (UMLS CUI [1])
Time of index event ECG
Item
Time of index event ECG
time
C2826846 (UMLS CUI [1])
Time of index event ECG is unknown
Item
Time of index event ECG is unknown
boolean
Persistent ST elevation
Item
New persistent ST elevation >= 1 mm
boolean
C2216134|C0520886 (UMLS CUI [1])
Transient ST elevation
Item
New transient ST elevation >= 1 mm
boolean
C0520886 (UMLS CUI [1])
Q wave
Item
New significant Q wave
boolean
C1305738 (UMLS CUI [1])
ST depression
Item
New ST depression >= 1 mm
boolean
C0520887 (UMLS CUI [1])
ST depression
Item
New ST depression between 0.5 mm and 1 mm
boolean
C0520887 (UMLS CUI [1])
ST or T wave changes
Item
New non-specific ST or T wave changes
boolean
C1112720 (UMLS CUI [1])
Left bundle branch block
Item
New left bundle branch block
boolean
C0023211 (UMLS CUI [1])
ECG abnormal
Item
No new changes but abnormal
boolean
C0522055 (UMLS CUI [1])
ECG Normal
Item
Normal
boolean
C0522054 (UMLS CUI [1])
Item
Lab Test Name
text
Code List
Lab Test Name
CL Item
Troponin I (1)
C0920210 (UMLS CUI-1)
CL Item
Troponin T (2)
C1141947 (UMLS CUI-1)
CL Item
Creatine Kinase (CK, CPK) (3)
C0201973 (UMLS CUI-1)
CL Item
CK Isoenzyme MB (4)
C0523584 (UMLS CUI-1)
Date of sample collection
Item
Date of sample collection
date
N (UMLS CUI [1])
Time of sample collection
Item
Time of sample collection (24 hour clock)
time
N (UMLS CUI [1])
Time of sample collection is unknown
Item
Time of sample collection is unknown
boolean
Numeric Result
Item
Numeric Result
boolean
Item
Unit
text
C1519795 (UMLS CUI [1])
Code List
Unit
CL Item
IU/L (IU/L)
I (UMLS CUI-1)
CL Item
Ukat/L (Ukat/L)
I (UMLS CUI-1)
CL Item
ULN (ULN)
I (UMLS CUI-1)
CL Item
U/L (U/L)
I (UMLS CUI-1)
CL Item
MIU/ml (MIU/ml)
I (UMLS CUI-1)
CL Item
% (%)
I (UMLS CUI-1)
CL Item
ug/L (ug/L)
I (UMLS CUI-1)
CL Item
ng/ml (ng/ml)
I (UMLS CUI-1)
CL Item
mg/dL (mg/dL)
I (UMLS CUI-1)
Upper Limit of Normal(ULN)
Item
Upper Limit of Normal(ULN)
float
C1519815 (UMLS CUI [1])
Item
x ULN or Positive/Negative
text
Code List
x ULN or Positive/Negative
CL Item
< ULN (< ULN)
I (UMLS CUI-1)
CL Item
1-2 x ULN (1-2 x ULN)
I (UMLS CUI-1)
CL Item
2-3 x ULN (2-3 x ULN)
I (UMLS CUI-1)
CL Item
3-5 x ULN (3-5 x ULN)
I (UMLS CUI-1)
CL Item
5-10 x ULN (5-10 x ULN)
I (UMLS CUI-1)
CL Item
>10 x ULN (>10 x ULN)
I (UMLS CUI-1)
CL Item
POSITIVE (POSITIVE)
I (UMLS CUI-1)
CL Item
NEGATIVE (NEGATIVE)
I (UMLS CUI-1)
Item Group
Hospital Discharge for Index Event
Date of discharge
Item
Date of hospital discharge for index event
date
C2361123 (UMLS CUI [1])
Time of discharge
Item
Time of hospital discharge for index event
time
C3864299 (UMLS CUI [1])
Time of hospital discharge unknown
Item
Time of hospital discharge for index event is unknown
boolean
Item Group
Medical History of Special Interest
Prior MI
Item
Previous Myocardial Infarction
boolean
C1275835 (UMLS CUI [1])
Date of MI
Item
Most recent onset date prior to event admission
date
C2924287 (UMLS CUI [1])
Angina pectoris
Item
Angina
boolean
C0002962 (UMLS CUI [1])
Angina onset date
Item
Most recent onset date prior to event admission
date
C2984181 (UMLS CUI [1])
Item
If 'Yes', Canadian Classification at 1 month prior to admission
text
C1277207 (UMLS CUI [1])
Code List
If 'Yes', Canadian Classification at 1 month prior to admission
CL Item
None (1)
I (UMLS CUI-1)
CL Item
I (2)
I (UMLS CUI-1)
CL Item
II (3)
I (UMLS CUI-1)
CL Item
III (4)
I (UMLS CUI-1)
CL Item
IV (5)
I (UMLS CUI-1)
Coronary Artery Disease
Item
Coronary Artery Disease with Stenosis >= 50%
boolean
C1956346 (UMLS CUI [1])
Onset of coronary heart disease
Item
Most recent onset date prior to event admission
date
C0574845 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
Family History of Coronary Heart Disease
Item
Family History of Coronary Heart Disease
boolean
C2317524 (UMLS CUI [1])
Congestive Heart Disease
Item
Congestive Heart Disease
boolean
C0018802 (UMLS CUI [1])
Congestive heart disease onset date
Item
Most recent onset date prior to event admission
date
C0018802 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Atrial Fibrillation
Item
Atrial Fibrillation
boolean
C0004238 (UMLS CUI [1])
Atrial fibrillation onset date
Item
Most recent onset date prior to event admission
date
C0004238 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Prior PCI
Item
Percutaneous Coronary Intervention
boolean
C1320647 (UMLS CUI [1])
Date of prior PCI
Item
Most recent onset date prior to event admission
date
C1264639 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
CABG
Item
Coronary Artery Bypass Graft Surgery
boolean
C0010055 (UMLS CUI [1])
Date of CABG
Item
Most recent onset date prior to event admission
date
C2164190 (UMLS CUI [1])
Item
Diabetes Mellitus
text
C0011849 (UMLS CUI [1])
Code List
Diabetes Mellitus
CL Item
Insulin Use (1)
C0421248 (UMLS CUI-1)
CL Item
Retinopathy (2)
C0011884 (UMLS CUI-1)
Hypertension
Item
Hypertension Requiring Medical Therapy
boolean
C0020538 (UMLS CUI [1])
Heart valve disease
Item
Valvular Heart Disease
boolean
C0018824 (UMLS CUI [1])
Hypercholesterolemia
Item
Hypercholesterolemia Requiring Medical Therapy
boolean
C0020443 (UMLS CUI [1])
Item
Cigarette Smoking
text
C0543414 (UMLS CUI [1])
Code List
Cigarette Smoking
CL Item
Stopped <= 1 year ago (1)
I (UMLS CUI-1)
CL Item
Current smoker (3)
C3241966 (UMLS CUI-1)
CL Item
Stopped > 1 year ago (I)
I (UMLS CUI-1)
Item
Alcohol Consumption
text
C0001948 (UMLS CUI [1])
Code List
Alcohol Consumption
CL Item
Abstinent (1)
I (UMLS CUI-1)
CL Item
Light alcohol consumption (2)
I (UMLS CUI-1)
CL Item
Moderate alcohol consumption (3)
I (UMLS CUI-1)
CL Item
Heavy alcohol consumption (4)
I (UMLS CUI-1)
Peripheral Arterial Disease
Item
Peripheral Arterial Disease
boolean
C0085096 (UMLS CUI [1])
Stroke
Item
Stroke
boolean
C0038454 (UMLS CUI [1])
Stroke date
Item
Most recent onset date prior to event admission
date
C0038454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Transient Ischemic Attack
Item
Transient Ischemic Attack
boolean
C0007787 (UMLS CUI [1])
TIA date
Item
Most recent onset date prior to event admission
date
C0011008 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
Item
Known Carotid Stenosis (>=50%)
text
C0007282 (UMLS CUI [1])
Code List
Known Carotid Stenosis (>=50%)
CL Item
Carotid stent (1)
C0850458 (UMLS CUI-1)
CL Item
Angioplasty (2)
C0162577 (UMLS CUI-1)
Date of carotid stenosis
Item
Most recent onset date prior to event admission
date
C0007282 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Liver Disease
Item
Liver Disease
boolean
C0085605 (UMLS CUI [1])
Liver disease date
Item
Most recent onset date prior to event admission
date
C0085605 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Peptic Ulcer
Item
Peptic Ulcer Disease
boolean
C0030920 (UMLS CUI [1])
Date of Peptic Ulcer
Item
Most recent onset date prior to event admission
date
C0011008 (UMLS CUI [1,1])
C0030920 (UMLS CUI [1,2])
Gastrointestinal Hemorrhage
Item
Gastrointestinal Bleeding
boolean
C0017181 (UMLS CUI [1])
Date of gastrointestinal hemorrhage
Item
Most recent onset date prior to event admission
date
C0017181 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Chronic Kidney Failure
Item
Chronic Renal Insufficiency
boolean
C0022661 (UMLS CUI [1])
Item Group
Vital Signs at Screening
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C0455829 (UMLS CUI [1])
Heart Rate
Item
Heart Rate (beats/min)
integer
C0018810 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure (mmHg)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure (mmHg)
integer
C0428883 (UMLS CUI [1])
Item Group
Vital Signs
Heart Rate
Item
Heart Rate (beats/min)
integer
C0018810 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure (mmHg)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure (mmHg)
integer
C0428883 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item Group
Study Medication Review
Item Group
First Dose of Study Medication
Date of first dose
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Time of first dose
Item
Time of first dose
time
Time of first dose is unknown
Item
Time of first dose is unknown
boolean
Item Group
Concomitant Therapy
Item Group
Aspirin Concomitant Therapy
C0004057 (UMLS CUI-1)
Aspirin dose
Item
Total daily dose
integer
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Aspirin Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
Aspirin Start Time
Item
Start Time
time
Start time is unknown
Item
Start time is unknown
boolean
Prior to Study Entry?
Item
Prior to Study Entry?
text
Aspirin Stop Date
Item
Stop Date
text
Aspirin Stop Time
Item
Stop Time
text
Stop time is unknown
Item
Stop time is unknown
text
Ongoing at Study End?
Item
Ongoing at Study End?
text
Item Group
Thienopyridine Concomitant Therapy
C2936588 (UMLS CUI-1)
Item
Reported Name of Drug, Med or Therapy
text
Code List
Reported Name of Drug, Med or Therapy
CL Item
CLOPIDOGREL (CLOPIDOGREL)
C0070166 (UMLS CUI-1)
CL Item
TICLOPIDINE (TICLOPIDINE)
C0040207 (UMLS CUI-1)
CL Item
OTHER (OTHER)
I (UMLS CUI-1)
Thienopyridine dose
Item
Total daily dose
text
C0178602 (UMLS CUI [1,1])
C2936588 (UMLS CUI [1,2])
Prior to Study Entry?
Item
Prior to Study Entry?
boolean
Thienopyridine Start Date
Item
Start Date
text
C2936588 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Thienopyridine Start Time
Item
Start Time
time
Start Time is unknown
Item
Start Time is unknown
boolean
Ongoing at Study End?
Item
Ongoing at Study End?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Stop Time is unknown
Item
Stop Time is unknown
boolean
Item Group
Unfractionated Heparin
C2825026 (UMLS CUI-1)
Unfractionated Heparin dose
Item
Total daily dose
text
C2825026 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prior to Study Entry?
Item
Prior to Study Entry?
boolean
Unfractionated Heparin Start Date
Item
Start Date
date
C1301880 (UMLS CUI [1,1])
C2825026 (UMLS CUI [1,2])
Unfractionated Heparin Start Time
Item
Start Time
time
Start Time is unknown
Item
Start Time is unknown
boolean
Ongoing at Study End?
Item
Ongoing at Study End?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Stop Time is unknown
Item
Stop Time is unknown
boolean
Item Group
Low Molecular Weight Heparin
C0019139 (UMLS CUI-1)
Item
Reported Name of Drug, Med or Therapy
text
Code List
Reported Name of Drug, Med or Therapy
CL Item
ARDEPARIN (ARDEPARIN)
C0297269 (UMLS CUI-1)
CL Item
BEMIPARIN (BEMIPARIN)
C0916062 (UMLS CUI-1)
CL Item
CERTOPARIN (CERTOPARIN)
C0592532 (UMLS CUI-1)
CL Item
DALTEPARIN (DALTEPARIN)
C0206461 (UMLS CUI-1)
CL Item
ENOXAPARIN (ENOXAPARIN)
C0206460 (UMLS CUI-1)
CL Item
NADROPARIN (NADROPARIN)
C0206232 (UMLS CUI-1)
CL Item
PARNAPARIN (PARNAPARIN)
C0215717 (UMLS CUI-1)
CL Item
REVIPARIN (REVIPARIN)
C0254215 (UMLS CUI-1)
CL Item
TINZAPARIN (TINZAPARIN)
C0216278 (UMLS CUI-1)
CL Item
OTHER (OTHER)
LMWH dose
Item
Total Daily Dose
text
C3536766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prior to Study Entry?
Item
Prior to Study Entry?
boolean
LMWH Start Date
Item
Start Date
date
C3536766 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
LMWH Start Time
Item
Start Time
time
Start Time is unknown
Item
Start Time is unknown
boolean
Ongoing at Study End?
Item
Ongoing at Study End?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
End Time is unknown
Item
End Time is unknown
boolean
Item Group
Other Parenteral Anticoagulant
C3536847 (UMLS CUI-1)
Item
Reported Name of Drug, Med or Therapy
text
Code List
Reported Name of Drug, Med or Therapy
CL Item
BIVALIRUDIN (BIVALIRUDIN)
C0168273 (UMLS CUI-1)
CL Item
DANAPAROID (DANAPAROID)
C0259507 (UMLS CUI-1)
CL Item
FONDAPARINUX (FONDAPARINUX)
C1098510 (UMLS CUI-1)
CL Item
LEPIRUDIN (LEPIRUDIN)
C0772394 (UMLS CUI-1)
CL Item
OTHER (OTHER)
Anticoagulant dose
Item
Total Daily Dose
text
C3536847 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prior to Study Entry?
Item
Prior to Study Entry?
boolean
Anticoagulant Start Date
Item
Start Date
date
C3536847 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Anticoagulant Start Time
Item
Start Time
time
Start Time is unknown
Item
Start Time is unknown
boolean
Ongoing at Study End?
Item
Ongoing at Study End?
boolean
Anticoagulant Stop Date
Item
Stop Date
date
Anticoagulant Stop Time
Item
Stop Time
time
Stop Time is unknown
Item
Stop Time is unknown
boolean
Item Group
Oral Anticoagulant
C0354604 (UMLS CUI-1)
Item
Reported Name of Drug, Med or Therapy
text
Code List
Reported Name of Drug, Med or Therapy
CL Item
ACENOCOUMAROL (ACENOCOUMEROL)
C0000956 (UMLS CUI-1)
CL Item
ANISINDIONE (ANISINDIONE)
C0051919 (UMLS CUI-1)
CL Item
DICUMEROL (DICUMEROL)
N (UMLS CUI-1)
CL Item
FLUINDIONE (FLUINDIONE)
C0117899 (UMLS CUI-1)
CL Item
PHENINDIONE (PHENINDIONE)
C0031406 (UMLS CUI-1)
CL Item
PHENPROCOUMON (PHENPROCOUMON)
C0031444 (UMLS CUI-1)
CL Item
WARFARIN (WARFARIN)
C0043031 (UMLS CUI-1)
CL Item
OTHER (OTHER)
Oral Anticoagulant dose
Item
Total Daily Dose
text
C0354604 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prior to Study Entry?
Item
Prior to Study Entry?
boolean
Oral Anticoagulant Start Date
Item
Start Date
date
C0354604 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Oral Anticoagulant Start Time
Item
Start Time
time
Start Time is unknown
Item
Start Time is unknown
boolean
Ongoing at Study End?
Item
Ongoing at Study End?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Stop Time is unknown
Item
Stop Time is unknown
boolean
Item Group
Glycoprotein IIb/IIIa Inhibitor
C3640054 (UMLS CUI-1)
Item
Reported Name of Drug, Med or Therapy
text
Code List
Reported Name of Drug, Med or Therapy
CL Item
ABCIXIMAB (ABCIXIMAB)
C0288672 (UMLS CUI-1)
CL Item
EPTIFIBATIDE (EPTIFIBATIDE)
C0253563 (UMLS CUI-1)
CL Item
TIROFIBAN (TIROFIBAN)
C0247025 (UMLS CUI-1)
CL Item
OTHER (OTHER)
GP IIb/IIIa inhibitor dose
Item
Total Daily Dose
text
C3640054 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prior to Study Entry?
Item
Prior to Study Entry?
boolean
GP IIb/IIIa inhibitor Start Date
Item
Start Date
date
C1301880 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
GP IIb/IIIa inhibitor Start Time
Item
Start Time
time
Start Time Unknown
Item
Start Time Unknown
boolean
Ongoing at Study End?
Item
Ongoing at Study End?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Stop Time Unknown
Item
Stop Time Unknown
boolean
Item Group
Fibrinolytic
C0040044 (UMLS CUI-1)
Item
Reported Name of Drug, Med or Therapy
text
Code List
Reported Name of Drug, Med or Therapy
CL Item
ALTEPLASE (ALTEPLASE)
C0032143 (UMLS CUI-1)
CL Item
ANISTREPLASE (ANISTREPLASE)
C0078956 (UMLS CUI-1)
CL Item
RETEPLASE (RETEPLASE)
C0256103 (UMLS CUI-1)
CL Item
STREPTOKINASE (STREPTOKINASE)
C0038418 (UMLS CUI-1)
CL Item
TENECTEPLASE (TENECTEPLASE)
C0872913 (UMLS CUI-1)
CL Item
UROKINASE (UROKINASE)
C0042071 (UMLS CUI-1)
CL Item
OTHER (OTHER)
Fibrinolytic dose
Item
Total Daily Dose
text
C0178602 (UMLS CUI [1,1])
C0040044 (UMLS CUI [1,2])
Prior to Study Entry?
Item
Prior to Study Entry?
boolean
Fibrinolytic start date
Item
Start Date
date
C0040044 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Fibrinolytic start time
Item
Start time
time
Start Time is unknown
Item
Start Time is unknown
boolean
Ongoing at Study End?
Item
Ongoing at Study End?
boolean
Fibrinolytic Stop Date
Item
Stop Date
date
Fibrinolytic Stop Time
Item
Stop Time
time
Stop time is unknown
Item
Stop time is unknown
boolean
Item Group
ECG
C1623258 (UMLS CUI-1)
ECG date
Item
Date of ECG
date
C2826846 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
Time of ECG is unknown
Item
Time of ECG is unknown
boolean
Item Group
Unscheduled ECG
Item Group
DNA Sample
Item Group
DNA Sample Consent Modification
Item Group
DNA Sample Replacement
Item Group
Neurological Exam/Modified Rankin Scale
Item Group
Seattle Angina Questionnaire (Question 1)
Item Group
Echocardiogram
C0013516 (UMLS CUI-1)
Accession number
Item
Accession number
text
Date of Echocardiogram
Item
Date of Echocardiogram
date
C0013516 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Echocardiogram
Item
Time of Echocardiogram
time
Time of Echocardiogram is unknown
Item
Time of Echocardiogram is unknown
boolean
High Frequency Probe Used?
Item
High Frequency Probe Used?
boolean
N (UMLS CUI [1])
Left ventricular thrombus
Item
LV Thrombis Present or Absent?
boolean
C0587044 (UMLS CUI [1])
Ejection Fraction
Item
Ejection Fraction
text
C0232174 (UMLS CUI [1])
Item Group
Holter
Item Group
Medication Kit Number
Item Group
Central Lab Sample Collection
Item Group
PK/PD Sample Collection
Item Group
End of Screening / Randomization
Did subject complete the screening period including randomization?
Item
Did subject complete the screening period including randomization?
boolean
Randomization Number
Item
Randomization Number
text
Item
Primary reason for premature termination
text
C2348570 (UMLS CUI [1])
Code List
Primary reason for premature termination
CL Item
ADVERSE EVENT (ADVERSE EVENT)
CL Item
CONSENT WITHDRAWN (CONSENT WITHDRAWN)
CL Item
LOST TO FOLLOW UP (LOST TO FOLLOW UP)
CL Item
DEATH (DEATH)
CL Item
SUBJECT INELIGIBLE TO (SUBJECT INELIGIBLE TO)
CL Item
CONTINUE (CONTINUE)
Item Group
End of Treatment / Early Withdrawal
Did subject complete a double-blind treatment period?
Item
Did subject complete a double-blind treatment period?
boolean
Date of last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Time of last dose
Item
Time of last dose
time
Time of last dose is unknown
Item
Time of last dose is unknown
time
Item
Primary reason for premature termination
text
C2348570 (UMLS CUI [1])
Code List
Primary reason for premature termination
CL Item
ADVERSE EVENT (ADVERSE EVENT)
CL Item
CONSENT WITHDRAWN (CONSENT WITHDRAWN)
CL Item
LOST TO FOLLOW UP (LOST TO FOLLOW UP)
CL Item
DEATH (DEATH)
CL Item
OTHER (OTHER)
Item Group
End of Follow-up
C0589120 (UMLS CUI-1)
Did the subject complete follow-up period
Item
Did the subject complete follow-up period
boolean
C0589120 (UMLS CUI [1])
Date of final contact
Item
Date of final contact
date
C0805839 (UMLS CUI [1])
Item
If 'Not complete follow-up period' indicate reason
text
Code List
If 'Not complete follow-up period' indicate reason
CL Item
ADVERSE EVENT (ADVERSE EVENT)
CL Item
CONSENT WITHDRAWN (CONSENT WITHDRAWN)
CL Item
LOST TO FOLLOW UP (LOST TO FOLLOW UP)
CL Item
DEATH (DEATH)
CL Item
OTHER (OTHER)
Item Group
CEC Adjudicated Form
Item
DEATH
text
C1306577 (UMLS CUI [1])
Code List
DEATH
CL Item
CARDIOVASCULAR (CARDIOVASCULAR)
CL Item
NON-CARDIOVASCULAR (NON-CARDIOVASCULAR)
CL Item
UNKNOWN (UNKNOWN)
Item
MIOCARDIAL INFARCTION
text
C0027051 (UMLS CUI [1])
Code List
MIOCARDIAL INFARCTION
CL Item
FIRST MI (FIRST MI)
CL Item
RE-MI (RE-MI)
Item
MI Sub-category
text
Code List
MI Sub-category
CL Item
STEMI (STEMI)
C1536220 (UMLS CUI-1)
CL Item
NSTEMI (NSTEMI)
C3537184 (UMLS CUI-1)
Item
STROKE
text
C0038454 (UMLS CUI [1])
Code List
STROKE
CL Item
ISCHEMIC CEREBRAL (ISCHEMIC CEREBRAL)
CL Item
INFARCTION (INFARCTION)
CL Item
INFARCTION WITH (INFARCTION WITH)
CL Item
HEMORRHAGIC (HEMORRHAGIC)
CL Item
CONVERSION (CONVERSION)
CL Item
PRIMARY HEMORRHAGIC (PRIMARY HEMORRHAGIC)
CL Item
UNCERTAIN (UNCERTAIN)
Item
RECURRENT ISCHEMIA
text
C0151744 (UMLS CUI [1])
Code List
RECURRENT ISCHEMIA
CL Item
SEVERE RECURRENT (SEVERE RECURRENT)
CL Item
ISCHEMIA REQUIRING REVASCULARIZATION (ISCHEMIA REQUIRING REVASCULARIZATION)
Embolism
Item
NON-CNS SYSTEMIC EMBOLISM
text
C0013922 (UMLS CUI [1])
Item
BLEEDING EVENTS
text
C0019080 (UMLS CUI [1])
Code List
BLEEDING EVENTS
CL Item
TIMI MAJOR BLEEDING (TIMI MAJOR BLEEDING)
CL Item
TIMI MINOR BLEEDING (TIMI MINOR BLEEDING)
CL Item
BLEEDING REQUIRING (BLEEDING REQUIRING)
CL Item
MEDICAL ATTENTION (MEDICAL ATTENTION)
CL Item
CLINICALLY SIGNIFICANT BLEEDING (CLINICALLY SIGNIFICANT BLEEDING)
CL Item
INSIGNIFICANT BLEEDING (INSIGNIFICANT BLEEDING)
Item Group
Death Adjudication
Item Group
Myocardial Infarction and Recurrent Ischemia Adjudication
Myocardial infarction
Item
MI (not within 72 hours of index event or following PCI/CABG):
text
C0027051 (UMLS CUI [1])
Troponin or CK-MB
Item
Troponin or CK-MB > ULN
text
C0523584|C0523952 (UMLS CUI [1])
Q waves
Item
ECG evidence of new Q waves
text
C1305738 (UMLS CUI [1])
Myocardial Infarction
Item
MI within the first 72 hours after the index MI
text
C0027051 (UMLS CUI [1])
Troponin or CK-MB
Item
Re-elevation of the troponin or CK-MB > ULN and increased by at least 50% over the previous value, which was stable or decreasing (if not available, CK > 2 times ULN and increased by at least 50% over the previous value, which was stable or decreasing )
text
C0523584|C0523952 (UMLS CUI [1])
CK-MB
Item
Following PCI, CK-MB (or CK ) > 3 times ULN and increased by at least 50% over the previous value, which was stable or decreasing
text
C0523584 (UMLS CUI [1])
Q wave
Item
ECG evidence of new Q waves
text
C1305738 (UMLS CUI [1])
Myocardial Infarction
Item
MI within 24 hours after PCI (not within 72 hours of the index event):
text
C0027051 (UMLS CUI [1])
CK-MB
Item
CK-MB (or CK) > 3 times ULN and if the pre-PCI level > ULN, then increased by at least 50% over the previous value, which was stable or decreasing)
text
C0523584 (UMLS CUI [1])
Item Group
Severe Recurrent Ischemia Adjudication
ECG signs of myocardial ischaemia
Item
New ischemic ECG changes (i.e., ST-segment elevation or depression or T wave inversion in at least 2 adjacent leads)
text
C1141959 (UMLS CUI [1])
CK-MB
Item
Increase in CK-MB not meeting criteria for MI
text
C0523584 (UMLS CUI [1])
Coronary angiography, PCI, or CABG
Item
Need for unplanned coronary angiography, PCI, or CABG
text
C0085532|C1532338|C0010055 (UMLS CUI [1])
Item Group
Stroke Adjudication
Item Group
NON-CNS Systemic Embolization Adjudication
Item Group
Clinically Significant Bleeding Event Adjudication Form
Item Group
Stent Thrombosis Adjudication
Item Group
Canadian Cardiovascular Society Classification of Angina
Item
Canadian Cardiovascular Society Classification of Angina
text
C1879987 (UMLS CUI [1])
Code List
Canadian Cardiovascular Society Classification of Angina
CL Item
NONE (NONE)
CL Item
I (I)
CL Item
II (II)
CL Item
III (III)
CL Item
IV (IV)
Item Group
Events and Procedures Review
Death
Item
Death
boolean
C1306577 (UMLS CUI [1])
Myocardial Ischemia
Item
Cardiac Ischemic Event
boolean
C0151744 (UMLS CUI [1])
Coronary Revascularization
Item
Coronary Revascularization
text
C0877341 (UMLS CUI [1])
Stroke
Item
Stroke / TIA
boolean
C0038454 (UMLS CUI [1])
Hemorrhage
Item
Bleeding Event
boolean
C0019080 (UMLS CUI [1])
Embolization
Item
Non-CNS Systemic Embolization
boolean
C0013931 (UMLS CUI [1])
Adverse Event
Item
Adverse Event
boolean
C0877248 (UMLS CUI [1])
Stress Test
Item
Stress Test
boolean
C1384495 (UMLS CUI [1])
Echocardiography
Item
Echocardiography
boolean
C0013516 (UMLS CUI [1])
Radionucleotide Angiography
Item
Radionucleotide Angiography
boolean
C3865861 (UMLS CUI [1])
Cardiac Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1])
Cardiac Defibrillator
Item
Intracardiac Defibrillator
boolean
C1273352 (UMLS CUI [1])
Intra-aortic Balloon Pump
Item
Intra-aortic Balloon Pump
boolean
C0021860 (UMLS CUI [1])
Left Ventricular Assist Device
Item
Left Ventricular Assist Device
boolean
C0181598 (UMLS CUI [1])
Electrophysiology Study
Item
Electrophysiology Study
boolean
C1446476 (UMLS CUI [1])
Holter Electrocardiography
Item
Unplanned Holter Monitor
boolean
C0013801 (UMLS CUI [1])
Pulmonary Artery Catheter
Item
Pulmonary Artery Catheter
boolean
C0190658 (UMLS CUI [1])
Ventilator
Item
Ventilator
boolean
C0087153 (UMLS CUI [1])
Ventilation/Perfusion Scan
Item
Ventilation/Perfusion Scan
boolean
C0560738 (UMLS CUI [1])
Pulmonary Angiography
Item
Pulmonary Angiography
boolean
C0677490 (UMLS CUI [1])
CT or MRI Imaging
Item
CT or MRI Imaging
boolean
C0024485|C0040405 (UMLS CUI [1])
Coronary Angiography
Item
Coronary Angiography
boolean
C0085532 (UMLS CUI [1])
Percutaneous Peripheral Vascular Intervention
Item
Percutaneous Peripheral Vascular Intervention
boolean
C2609295 (UMLS CUI [1])
Percutaneous Cerebrovascular Intervention
Item
Percutaneous Cerebrovascular Intervention
boolean
N (UMLS CUI [1])
Surgical Procedure
Item
Surgical Procedure (other than CABG)
boolean
C0543467 (UMLS CUI [1])
Other
Item
Other
boolean
Item Group
Death
Event Unique Identifier
Item
Event Unique Identifier
text
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Time of death
Item
Time of death
time
C1301931 (UMLS CUI [1])
Autopsy performed
Item
Autopsy performed
boolean
C0004398 (UMLS CUI [1])
Death witnessed
Item
Death witnessed
boolean
C2924291 (UMLS CUI [1])
Item
Cause of death
text
C0007465 (UMLS CUI [1])
Code List
Cause of death
CL Item
CARDIOVASCULAR (CARDIOVASCULAR)
CL Item
NON-CARDIOVASCULAR (NON-CARDIOVASCULAR)
CL Item
UNKNOWN (UNKNOWN)
Item Group
Cardiac Ischemic Events
Event Unique Identifier
Item
Event Unique Identifier
text
Myocardial Ischemia
Item
Cardiac Ischemic Event
text
C0151744 (UMLS CUI [1])
ST elevation
Item
New persistent ST elevation >= 1 mm
text
C0520886 (UMLS CUI [1])
ST elevation
Item
New transient ST elevation >=1 mm
text
C0520886 (UMLS CUI [1])
Q wave
Item
New significant Q wave
text
C1305738 (UMLS CUI [1])
ST depression
Item
New ST depression >= 1 mm
text
C0520887 (UMLS CUI [1])
ST depression
Item
New ST depression >= 0.5 to 1 mm
text
C0520887 (UMLS CUI [1])
on-specific ST or T wave changes
Item
New non-specific ST or T wave changes
text
C1112720 (UMLS CUI [1])
Left bundle branch block
Item
New left bundle branch block
text
C0023211 (UMLS CUI [1])
ECG abnormal
Item
No new changes but abnormal
text
C0522055 (UMLS CUI [1])
ECG normal
Item
Normal
text
C0522054 (UMLS CUI [1])
Item Group
Coronary Revascularization
C0877341 (UMLS CUI-1)
Date of Coronary Revascularization
Item
Date of Coronary Revascularization
date
C0877341 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CABG
Item
Did subject undergo CABG?
boolean
C0010055 (UMLS CUI [1])
Lesion number
Item
Lesion number
integer
C0449791 (UMLS CUI [1])
Item
Site of Lesion
text
C0449695 (UMLS CUI [1])
Code List
Site of Lesion
CL Item
RCA (RCA)
CL Item
LMT (LMT)
CL Item
LAD (LAD)
CL Item
LCX (LCX)
CL Item
DIAG (DIAG)
CL Item
OM (OM)
CL Item
LM (LM)
CL Item
SVG (SVG)
CL Item
LIMA (LIMA)
CL Item
OTHER (OTHER)
Item
Graft Type
text
C0449494 (UMLS CUI [1])
Code List
Graft Type
CL Item
NO GRAFT (NO GRAFT)
CL Item
SAPHENOUS VEIN GRAFT (SAPHENOUS VEIN GRAFT)
CL Item
ARTERIAL GRAFT (ARTERIAL GRAFT)
Item
Graft Location
text
N (UMLS CUI [1])
Code List
Graft Location
CL Item
NO GRAFT (NO GRAFT)
CL Item
PROXIMAL ANASTOMOSIS (PROXIMAL ANASTOMOSIS)
CL Item
SHAFT (<3 mm OF (SHAFT (<3 mm OF)
CL Item
ANASTOMOSIS) (ANASTOMOSIS))
CL Item
DISTAL ANASTOMOSIS (<3 (DISTAL ANASTOMOSIS (<3)
CL Item
mm OF ANASTOMOSIS (mm OF ANASTOMOSIS)
Culprit Lesion
Item
Culprit Lesion?
text
C1299364 (UMLS CUI [1])
Item
Total Stent Length
text
C0449462 (UMLS CUI [1])
Code List
Total Stent Length
CL Item
20 mm (<)
CL Item
21 - 30 mm (21 - 30 mm)
CL Item
31 - 40 mm (31 - 40 mm)
CL Item
> 40 mm (> 40 mm)
Item
Stent size
text
N (UMLS CUI [1])
Code List
Stent size
CL Item
1.5 (1.5)
CL Item
2.0 (2.0)
CL Item
2.5 (2.5)
CL Item
2.75 (2.75)
CL Item
3.0 (3.0)
CL Item
3.5 (3.5)
CL Item
4.0 (4.0)
CL Item
4.5 (4.5)
CL Item
5.0 (5.0)
CL Item
5.5 (5.5)
Item
Device used
text
N (UMLS CUI [1])
Code List
Device used
CL Item
BARE METAL STENT (BARE METAL STENT)
CL Item
BALLOON ANGIOPLASTY (BALLOON ANGIOPLASTY)
CL Item
BALLOON OCCLUSION (BALLOON OCCLUSION)
CL Item
DEVICE (E.G. PERCUSURGE) (DEVICE (E.G. PERCUSURGE))
CL Item
DIRECT ATHERECTOMY (DIRECT ATHERECTOMY)
CL Item
BRACHYTHERAPY (BRACHYTHERAPY)
CL Item
LASER (LASER)
CL Item
OTHER (OTHER)
CL Item
CYPHER STENT (E.G. SIROLIMUS) (CYPHER STENT (E.G. SIROLIMUS))
CL Item
TAXUS STENT (E.G. PACLITAXEL) (TAXUS STENT (E.G. PACLITAXEL))
CL Item
OTHER DRUG ELUTING STENT (OTHER DRUG ELUTING STENT)
CL Item
FILTRATION WIRE DEVICE (E.G. ANGIOGUARD, FILTER WIRE) (FILTRATION WIRE DEVICE (E.G. ANGIOGUARD, FILTER WIRE))
CL Item
RHEOLYTIC THROMBECTOMY (E.G. ANGIOJET) (RHEOLYTIC THROMBECTOMY (E.G. ANGIOJET))
CL Item
ROTATIONAL ATHERECTOMY (ROTATIONAL ATHERECTOMY)
CL Item
EXTRACTION ATHERECTOMY (EXTRACTION ATHERECTOMY)
Item Group
Coronary Revascularization Prior to Signed Informed Consent
Item Group
Local Cardiac Biomarker Measurements
C1271630 (UMLS CUI-1)
Item
Lab Test Name
text
Code List
Lab Test Name
CL Item
TROPONIN I (TROPONIN I)
C0920210 (UMLS CUI-1)
CL Item
TROPONIN T (TROPONIN T)
C1141947 (UMLS CUI-1)
CL Item
CREATINE KINASE (CREATINE KINASE (CK, CPK))
C0201973 (UMLS CUI-1)
CL Item
CK MB (CK ISOENZYME MB)
C0523584 (UMLS CUI-1)
Item Group
Blood Transfusion
C0005841 (UMLS CUI-1)
Item Group
Stroke/TIA Events
Event Unique Identifier
Item
Event Unique Identifier
text
Stroke
Item
Stroke / TIA Event
text
C0038454 (UMLS CUI [1])
Stroke date
Item
Start Date
date
C0038454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Bleeding Events
C0019080 (UMLS CUI-1)
Event Unique Identifier
Item
Event Unique Identifier
text
Hemorrhage
Item
Bleeding Event
text
C0019080 (UMLS CUI [1])
Date of hemorrhage
Item
Start date of bleeding event
date
C0019080 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Primary location of bleeding
text
C0019080 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Code List
Primary location of bleeding
CL Item
BLEEDING ASSOCIATED WITH CARDIAC SURGERY (INCLUDING CABG) (BLEEDING ASSOCIATED WITH CARDIAC SURGERY (INCLUDING CABG))
CL Item
BLEEDING ASSOCIATED WITH NONCARDIAC SURGERY (BLEEDING ASSOCIATED WITH NONCARDIAC SURGERY)
CL Item
EPISTAXIS (EPISTAXIS)
CL Item
GASTROINTESTINAL (HEMATEMESIS OR MELENA) (GASTROINTESTINAL (HEMATEMESIS OR MELENA))
CL Item
GINGIVAL (GINGIVAL)
CL Item
HEMATOMA (HEMATOMA)
CL Item
HEMOPTYSIS (HEMOPTYSIS)
CL Item
INCREASED OR PROLONGED MENSTRUAL OR ABNORMAL VAGINAL BLEEDING (INCREASED OR PROLONGED MENSTRUAL OR ABNORMAL VAGINAL BLEEDING)
CL Item
INTRAARTICULAR (INTRAARTICULAR)
CL Item
INTRACRANIAL (INTRACRANIAL)
CL Item
INTRAMUSCULAR (WITH COMPARTMENT SYNDROME) (INTRAMUSCULAR (WITH COMPARTMENT SYNDROME))
CL Item
INTRAOCULAR (INTRAOCULAR)
CL Item
INTRASPINAL (INTRASPINAL)
CL Item
MACROSCOPIC (GROSS) (MACROSCOPIC (GROSS))
CL Item
HEMATURIA (HEMATURIA)
CL Item
PERICARDIAL (PERICARDIAL)
CL Item
PUNCTURE SITE (PUNCTURE SITE)
CL Item
RECTAL (RECTAL)
CL Item
RETROPERITONEAL (RETROPERITONEAL)
CL Item
SKIN (ECCHYMOSIS OTHER THAN AT INSTRUMENTED SITE) (SKIN (ECCHYMOSIS OTHER THAN AT INSTRUMENTED SITE))
CL Item
SUBCONJUNCTIVAL OR OTHER OCULAR (SUBCONJUNCTIVAL OR OTHER OCULAR)
CL Item
OTHER (OTHER)
Item Group
Local Hematology Measurements
Item
Lab Test Name
text
Code List
Lab Test Name
CL Item
HEMOGLOBIN (HEMOGLOBIN)
C0518015 (UMLS CUI-1)
CL Item
HEMATOCRIT (HEMATOCRIT)
C0018935 (UMLS CUI-1)
Item Group
Non-CNS Systemic Embolization Events
Item Group
Other Adverse Events
Item Group
Local Lab
Date of Sample Collection
Item
Date of Sample Collection
date
C1549498 (UMLS CUI [1])
Item
Lab Test Name
text
Code List
Lab Test Name
CL Item
HEMOGLOBIN (HEMOGLOBIN)
C0518015 (UMLS CUI-1)
CL Item
HEMATOCRIT (HEMATOCRIT)
C0018935 (UMLS CUI-1)
CL Item
BILIRUBIN, TOTAL (BILIRUBIN, TOTAL)
C0201913 (UMLS CUI-1)
CL Item
BILIRUBIN, DIRECT (BILIRUBIN, DIRECT)
C0201916 (UMLS CUI-1)
CL Item
BILIRUBIN, INDIRECT (BILIRUBIN, INDIRECT)
C1881193 (UMLS CUI-1)
CL Item
SGOT/AST (SGOT/AST)
C0201899 (UMLS CUI-1)
CL Item
SGPT/ALT (SGPT/ALT)
C0201836 (UMLS CUI-1)
CL Item
ALKALINE PHOSPHATASE (ALKALINE PHOSPHATASE)
C0201850 (UMLS CUI-1)
CL Item
TROPONIN I (TROPONIN I)
C0920210 (UMLS CUI-1)
CL Item
TROPONIN T (TROPONIN T)
C1141947 (UMLS CUI-1)
CL Item
CREATINE KINASE (CK,CPK) (CREATINE KINASE (CK,CPK))
C0201973 (UMLS CUI-1)
CL Item
CK ISOENZYME MB (CK ISOENZYME MB)
C0523584 (UMLS CUI-1)
CL Item
PLATELETS (PLATELETS)
C0032181 (UMLS CUI-1)
CL Item
CREATININE (CREATININE)
C0201975 (UMLS CUI-1)
Numeric Result
Item
Numeric Result
text
Item Group
Health Resource Utilization Review
Emergency Room
Item
Emergency Room Visit
boolean
C0583237 (UMLS CUI [1])
Hospitalization
Item
Hospitalization
boolean
C0019993 (UMLS CUI [1])
Urgent Care or Physician Office Visit
Item
Urgent Care or Physician Office Visit
boolean
C1551285 (UMLS CUI [1])
Skilled Nursing / Rehabilitation Facility
Item
Skilled Nursing / Rehabilitation Facility
boolean
C0037265 (UMLS CUI [1])
Rehabilitation
Item
Rehabilitation (Outpatient)
boolean
C0034991 (UMLS CUI [1])
Home Care
Item
Home Care Visit
boolean
C0204977 (UMLS CUI [1])
Item Group
Emergency Room Visits
Item Group
Hospitalization
Hospital Admission Date
Item
Hospital Admission Date
date
C0806429 (UMLS CUI [1])
Hospital Discharge Date
Item
Hospital Discharge Date
date
C2361123 (UMLS CUI [1])
Item
Type of Hospital
text
N (UMLS CUI [1])
Code List
Type of Hospital
CL Item
GENERAL/REGIONAL (GENERAL/REGIONAL)
CL Item
UNIVERSITY HOSPITAL (UNIVERSITY HOSPITAL)
CL Item
OTHER (OTHER)
Item
Type of Admission
text
C1550330 (UMLS CUI [1])
Code List
Type of Admission
CL Item
EMERGENCY (EMERGENCY)
CL Item
URGENT (URGENT)
CL Item
ELECTIVE (ELECTIVE)
CL Item
UNKNOWN (UNKNOWN)
Item
Type of Unit or Ward
text
N (UMLS CUI [1])
Code List
Type of Unit or Ward
CL Item
GENERAL / INTERNAL (GENERAL / INTERNAL)
CL Item
MEDICINE (MEDICINE)
CL Item
INTENSIVE CARE UNIT (INTENSIVE CARE UNIT)
CL Item
SURGERY (SURGERY)
CL Item
OTHER (OTHER)
Item
Reason Type
text
N (UMLS CUI [1])
Code List
Reason Type
CL Item
ADVERSE EVENTS RELATED TO ENDPOINTS (ADVERSE EVENTS RELATED TO ENDPOINTS)
CL Item
OTHER ADVERSE EVENT  (OTHER ADVERSE EVENT )
CL Item
SOCIAL REASONS (RESPITE, FAMILY RELATED) (SOCIAL REASONS (RESPITE, FAMILY RELATED))
CL Item
PREPLANNED / ELECTIVE (PREPLANNED / ELECTIVE)
Primary Reason for Hospitalization
Item
Primary Reason for Hospitalization
text
C0184666 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Urgent Care or Physician Office Visit
Item Group
Skilled Nursing/Rehabilitation Facility
Item Group
Rehabilitation (Outpatient)
Item Group
Home Care Visits
Item Group
Investigator Signature
Signature
Item
I have verified the data entries for this subject and have determined that they are complete, accurate, and in accordance with source documents.
text
C1519316 (UMLS CUI [1])

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