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ID
12553
Descrição
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.
Palavras-chave
Versões (2)
- 28/11/2015 28/11/2015 -
- 17/09/2021 17/09/2021 -
Titular dos direitos
ATLAS ACS-TIMI 46 study group
Transferido a
28 de novembro de 2015
DOI
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Licença
Creative Commons BY-NC 3.0
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Excerpt TIMI 46 Acute Coronary Syndrome NCT00402597
Similar models
ATLAS ACS TIMI 46
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Patient ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Subject Initials (first middle last)
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date (ddmonyyyy)
date
C1320303 (UMLS CUI [1])
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])
CL Item
Male (1)
CL Item
Female (2)
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)
CL Item
Hispanic or Latino (1)
CL Item
Not hispanic or Latino (2)
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
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])
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
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])
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])
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])
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])
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
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])
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)
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
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])
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])
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])
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])
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])
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])
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])
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)
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])
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])
C0007787 (UMLS CUI [1,2])
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])
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])
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])
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])
C0011008 (UMLS CUI [1,2])
Chronic Kidney Failure
Item
Chronic Renal Insufficiency
boolean
C0022661 (UMLS CUI [1])
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])
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 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
Aspirin dose
Item
Total daily dose
integer
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Aspirin Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
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
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])
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])
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
Unfractionated Heparin dose
Item
Total daily dose
text
C2825026 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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
Accession number
Item
Accession number
text
Date of Echocardiogram
Item
Date of Echocardiogram
date
C0013516 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
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])
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)
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])
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)
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)
CL Item
CARDIOVASCULAR (CARDIOVASCULAR)
CL Item
NON-CARDIOVASCULAR (NON-CARDIOVASCULAR)
CL Item
UNKNOWN (UNKNOWN)
CL Item
FIRST MI (FIRST MI)
CL Item
RE-MI (RE-MI)
CL Item
STEMI (STEMI)
C1536220 (UMLS CUI-1)
CL Item
NSTEMI (NSTEMI)
C3537184 (UMLS CUI-1)
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)
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])
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)
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])
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
Clinically Significant Bleeding Event Adjudication Form
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)
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
C1826995 (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
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])
CL Item
CARDIOVASCULAR (CARDIOVASCULAR)
CL Item
NON-CARDIOVASCULAR (NON-CARDIOVASCULAR)
CL Item
UNKNOWN (UNKNOWN)
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])
Date of Coronary Revascularization
Item
Date of Coronary Revascularization
date
C0877341 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
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)
CL Item
NO GRAFT (NO GRAFT)
CL Item
SAPHENOUS VEIN GRAFT (SAPHENOUS VEIN GRAFT)
CL Item
ARTERIAL GRAFT (ARTERIAL GRAFT)
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])
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)
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)
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)
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)
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])
C0011008 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
Item
Primary location of bleeding
text
C0019080 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
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)
CL Item
HEMOGLOBIN (HEMOGLOBIN)
C0518015 (UMLS CUI-1)
CL Item
HEMATOCRIT (HEMATOCRIT)
C0018935 (UMLS CUI-1)
Date of Sample Collection
Item
Date of Sample Collection
date
C1549498 (UMLS CUI [1])
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
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])
Hospital Admission Date
Item
Hospital Admission Date
date
C0806429 (UMLS CUI [1])
Hospital Discharge Date
Item
Hospital Discharge Date
date
C2361123 (UMLS CUI [1])
CL Item
GENERAL/REGIONAL (GENERAL/REGIONAL)
CL Item
UNIVERSITY HOSPITAL (UNIVERSITY HOSPITAL)
CL Item
OTHER (OTHER)
CL Item
EMERGENCY (EMERGENCY)
CL Item
URGENT (URGENT)
CL Item
ELECTIVE (ELECTIVE)
CL Item
UNKNOWN (UNKNOWN)
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)
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])
C0392360 (UMLS CUI [1,2])
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])