ID

31496

Beschrijving

Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

Trefwoorden

Versies (2)
  1. 28-08-18 28-08-18 -
  2. 28-08-18 28-08-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

28 augustus 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Study ID: 104574

Engels

Baseline Form

1 Formulieren  
  1. StudyEvent: ODM
    1. Baseline Form
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient ID, Centre No.
Beschrijving

Patient ID; Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2825181
UMLS CUI [1,3]
C1300638
Patient ID, Envelope No.
Beschrijving

Patient ID; Envelope Number

Datatype

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2348585
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient Information
Beschrijving

Patient Information

Alias
UMLS CUI-1
C1955348
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Birthdate
Beschrijving

Patient date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Subject Ethnicity
Beschrijving

Ethnic Group

Datatype

text

Alias
UMLS CUI [1]
C0015031
Height
Beschrijving

Body Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Clinical Assessment Pre-Randomization
Beschrijving

Clinical Assessment Pre-Randomization

Alias
UMLS CUI-1
C4534461
UMLS CUI-2
C0332152
UMLS CUI-3
C0034656
Date of onset of symptoms or procedure which prompted PCI
Beschrijving

Symptoms/procedure inducing PCI; date of onset

Datatype

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C1532338
UMLS CUI [1,4]
C0574845
UMLS CUI [2,1]
C0199171
UMLS CUI [2,2]
C0205263
UMLS CUI [2,3]
C1532338
UMLS CUI [2,4]
C0574845
Time of onset of symptoms or procedure which prompted PCI
Beschrijving

Symptoms/procedure inducing PCI; time of onset

Datatype

time

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C1532338
UMLS CUI [1,4]
C0449244
UMLS CUI [2,1]
C0199171
UMLS CUI [2,2]
C0205263
UMLS CUI [2,3]
C1532338
UMLS CUI [2,4]
C0449244
Baseline ECG - Date
Beschrijving

Baseline ECG; date

Datatype

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0011008
Baseline ECG - Time
Beschrijving

Baseline ECG; time

Datatype

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0040223
Baseline ECG - Result
Beschrijving

Baseline ECG; result

Datatype

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C1274040
ECG Rhythm
Beschrijving

ECG rhythm

Datatype

text

Alias
UMLS CUI [1]
C0232187
Left ventricular hypertrophy
Beschrijving

Left ventricular hypertrophy

Datatype

text

Alias
UMLS CUI [1]
C0149721
Intraventricular conduction delay (QRS > 120 msec)
Beschrijving

Intraventricular conduction delay (QRS > 120 msec)

Datatype

text

Alias
UMLS CUI [1,1]
C3697597
UMLS CUI [1,2]
C0429025
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Supine blood pressure
Beschrijving

Supine blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
Pre-Randomization Laboratory Tests
Beschrijving

Pre-Randomization Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0332152
UMLS CUI-3
C0034656
Date sample taken
Beschrijving

Laboratory Procedures; Specimen collection date

Datatype

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1302413
Time sample taken
Beschrijving

Laboratory Procedures; Specimen collection time

Datatype

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
Hemoglobin
Beschrijving

Hemoglobin

Datatype

float

Maateenheden
  • g/dl
Alias
UMLS CUI [1]
C0019046
g/dl
Hematocrit
Beschrijving

Hematocrit level

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1]
C0518014
%
Total WBC
Beschrijving

Total WBC

Datatype

float

Maateenheden
  • x 10⁹/L
Alias
UMLS CUI [1]
C0023508
x 10⁹/L
Platelet Count
Beschrijving

Platelet Count

Datatype

integer

Maateenheden
  • x 10⁹/L
Alias
UMLS CUI [1]
C0005821
x 10⁹/L
aPTT
Beschrijving

aPTT

Datatype

integer

Maateenheden
  • sec
Alias
UMLS CUI [1]
C0030605
sec
INR
Beschrijving

INR

Datatype

float

Alias
UMLS CUI [1]
C0525032
Creatinine
Beschrijving

Creatinine

Datatype

float

Maateenheden
  • µmol/L
Alias
UMLS CUI [1]
C0201976
µmol/L
Total CK
Beschrijving

Total CK

Datatype

integer

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201973
U/L
Total CK, Upper Limit of Normal
Beschrijving

Total CK; ULN

Datatype

integer

Maateenheden
  • U/L
Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C1519815
U/L
CK-MB
Beschrijving

CK-MB

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0523584
U/L
CK-MB; Upper Limit of Normal
Beschrijving

CK-MB; ULN

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1,1]
C0523584
UMLS CUI [1,2]
C1519815
U/L
CK-MB
Beschrijving

CK-MB

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1]
C0523584
%
CK-MB; Upper Limit of Normal
Beschrijving

CK-MB; ULN

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1,1]
C0523584
UMLS CUI [1,2]
C1519815
%
CK-MB Mass
Beschrijving

CK-MB Mass

Datatype

float

Maateenheden
  • µg/L
Alias
UMLS CUI [1,1]
C0523584
UMLS CUI [1,2]
C1306372
µg/L
CK-MB Mass
Beschrijving

CK-MB Mass ULN

Datatype

float

Maateenheden
  • µg/L
Alias
UMLS CUI [1,1]
C0523584
UMLS CUI [1,2]
C1306372
UMLS CUI [1,3]
C1519815
µg/L
Troponin T
Beschrijving

Troponin T

Datatype

float

Maateenheden
  • µg/L
Alias
UMLS CUI [1]
C1141947
µg/L
Troponin T; Upper Limit of Normal
Beschrijving

Troponin T; ULN

Datatype

float

Maateenheden
  • µg/L
Alias
UMLS CUI [1,1]
C1141947
UMLS CUI [1,2]
C1519815
µg/L
Troponin I
Beschrijving

Troponin I

Datatype

float

Maateenheden
  • µg/L
Alias
UMLS CUI [1]
C0920210
µg/L
Troponin I; Upper Limit of Normal
Beschrijving

Troponin I; ULN

Datatype

float

Maateenheden
  • µg/L
Alias
UMLS CUI [1,1]
C0920210
UMLS CUI [1,2]
C1519815
µg/L
Patient History
Beschrijving

Patient History

Alias
UMLS CUI-1
C0679831
MI
Beschrijving

Patient History; MI

Datatype

boolean

Alias
UMLS CUI [1]
C1275835
MI, Date of most recent
Beschrijving

Patient History; MI; Date of most recent

Datatype

date

Alias
UMLS CUI [1,1]
C1275835
UMLS CUI [1,2]
C2924287
UMLS CUI [1,3]
C1513491
Previous PCI with stent
Beschrijving

Patient History; Previous PCI with stent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0038257
Previous PCI with stent, Date of most recent
Beschrijving

Patient History; Previous PCI with stent; Date of most recent

Datatype

date

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0038257
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C1513491
Previous PCI without stent
Beschrijving

Patient History; Previous PCI without stent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C1532338
Previous PCI without stent, Date of most recent
Beschrijving

Patient History; Previous PCI without stent; Date of most recent

Datatype

date

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1513491
CABG Surgery
Beschrijving

Patient History; CABG Surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0010055
CABG Surgery, Date of most recent
Beschrijving

Patient History; CABG Surgery, Date of most recent

Datatype

date

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1513491
CABG Surgery, Date of most recent
Beschrijving

Patient History; CABG Surgery, Date of most recent

Datatype

date

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1513491
Other evidence of Coronary Artery Disease (CAD)
Beschrijving

Patient History; Coronary Artery Disease, Evidence, Other

Datatype

text

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C1956346
UMLS CUI [1,3]
C0332120
UMLS CUI [1,4]
C0205394
Family history of early onset CAD
Beschrijving

Patient History; Family history; Coronary Artery Disease, Early-onset

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0241889
UMLS CUI [1,3]
C1956346
UMLS CUI [1,4]
C1833334
Stroke
Beschrijving

Patient History; Stroke

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0038454
Stroke, Date of most recent
Beschrijving

Patient History; Stroke; Date in time; most recent

Datatype

date

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1513491
Peripheral arterial disease
Beschrijving

Patient History; Peripheral arterial disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C1704436
Hypertension
Beschrijving

Patient History; Hypertension

Datatype

text

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0020538
Heart Failure
Beschrijving

Patient History; Heart Failure

Datatype

text

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0018801
Diabetes
Beschrijving

Patient History; Diabetes

Datatype

text

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0011849
Diabetes, Date of first diagnosis
Beschrijving

Patient History; Diabetes; Date of diagnosis

Datatype

date

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C2316983
Hypercholesterolemia
Beschrijving

Patient History; Hypercholesterolemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0020443
Cancer
Beschrijving

Patient History; Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0006826
Cancer, Date of first diagnosis
Beschrijving

Patient History; Malignant Neoplasms, date of diagnosis

Datatype

date

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C2316983
Cancer, site
Beschrijving

Patient History; Malignant Neoplasms, site

Datatype

text

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C1515974
Other relevant ongoing medical conditions prior to randomization
Beschrijving

Patient History; concomitant disease

Datatype

text

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0243087
Other relevant ongoing medical conditions prior to randomization
Beschrijving

Patient History; smoker

Datatype

text

Alias
UMLS CUI [1,1]
C0679831
UMLS CUI [1,2]
C0243087
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Similar models

Baseline Form

1 Formulieren
  1. StudyEvent: ODM
    1. Baseline Form
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID; Centre Number
Item
Patient ID, Centre No.
text
C1269815 (UMLS CUI [1,1])
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
Patient ID; Envelope Number
Item
Patient ID, Envelope No.
text
C1269815 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female - Pre-menopausal - Postive Pregnancy Test (Female - Pre-menopausal - Postive Pregnancy Test)
CL Item
Female - Pre-menopausal - Negative Pregnancy Test (Female - Pre-menopausal - Negative Pregnancy Test)
CL Item
FEmale - Post-menopausal (FEmale - Post-menopausal)
Patient date of birth
Item
Birthdate
date
C0421451 (UMLS CUI [1])
Ethnic Group
Item
Subject Ethnicity
text
C0015031 (UMLS CUI [1])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Clinical Assessment Pre-Randomization
C4534461 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0034656 (UMLS CUI-3)
Symptoms/procedure inducing PCI; date of onset
Item
Date of onset of symptoms or procedure which prompted PCI
date
C1457887 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])
C0199171 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
C0574845 (UMLS CUI [2,4])
Symptoms/procedure inducing PCI; time of onset
Item
Time of onset of symptoms or procedure which prompted PCI
time
C1457887 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0449244 (UMLS CUI [1,4])
C0199171 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
C0449244 (UMLS CUI [2,4])
Baseline ECG; date
Item
Baseline ECG - Date
date
C0013798 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Baseline ECG; time
Item
Baseline ECG - Time
time
C0013798 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Baseline ECG - Result
text
C0013798 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Baseline ECG; result
Code List
Baseline ECG - Result
CL Item
Normal (Normal)
CL Item
Abnormal (specify type and location) (Abnormal (specify type and location))
Item
ECG Rhythm
text
C0232187 (UMLS CUI [1])
Baseline ECG; result
Code List
ECG Rhythm
Item
Left ventricular hypertrophy
text
C0149721 (UMLS CUI [1])
Left ventricular hypertrophy
Code List
Left ventricular hypertrophy
CL Item
No (No)
CL Item
Yes (Voltage criteria? Strain criteria?) (Yes (Voltage criteria? Strain criteria?))
Item
Intraventricular conduction delay (QRS > 120 msec)
text
C3697597 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Intraventricular conduction delay (QRS > 120 msec)
Code List
Intraventricular conduction delay (QRS > 120 msec)
CL Item
Right BBB (Right BBB)
CL Item
Left BBB (Left BBB)
CL Item
Non-specific (Non-specific)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Supine blood pressure
Item
Supine blood pressure
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Item Group
Pre-Randomization Laboratory Tests
C0022885 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0034656 (UMLS CUI-3)
Laboratory Procedures; Specimen collection date
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Laboratory Procedures; Specimen collection time
Item
Time sample taken
time
C0022885 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Hematocrit level
Item
Hematocrit
integer
C0518014 (UMLS CUI [1])
Total WBC
Item
Total WBC
float
C0023508 (UMLS CUI [1])
Platelet Count
Item
Platelet Count
integer
C0005821 (UMLS CUI [1])
aPTT
Item
aPTT
integer
C0030605 (UMLS CUI [1])
INR
Item
INR
float
C0525032 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Total CK
Item
Total CK
integer
C0201973 (UMLS CUI [1])
Total CK; ULN
Item
Total CK, Upper Limit of Normal
integer
C0201973 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
CK-MB
Item
CK-MB
float
C0523584 (UMLS CUI [1])
CK-MB; ULN
Item
CK-MB; Upper Limit of Normal
float
C0523584 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
CK-MB
Item
CK-MB
integer
C0523584 (UMLS CUI [1])
CK-MB; ULN
Item
CK-MB; Upper Limit of Normal
integer
C0523584 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
CK-MB Mass
Item
CK-MB Mass
float
C0523584 (UMLS CUI [1,1])
C1306372 (UMLS CUI [1,2])
CK-MB Mass ULN
Item
CK-MB Mass
float
C0523584 (UMLS CUI [1,1])
C1306372 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
Troponin T
Item
Troponin T
float
C1141947 (UMLS CUI [1])
Troponin T; ULN
Item
Troponin T; Upper Limit of Normal
float
C1141947 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Troponin I
Item
Troponin I
float
C0920210 (UMLS CUI [1])
Troponin I; ULN
Item
Troponin I; Upper Limit of Normal
float
C0920210 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Item Group
Patient History
C0679831 (UMLS CUI-1)
Patient History; MI
Item
MI
boolean
C1275835 (UMLS CUI [1])
Patient History; MI; Date of most recent
Item
MI, Date of most recent
date
C1275835 (UMLS CUI [1,1])
C2924287 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
Patient History; Previous PCI with stent
Item
Previous PCI with stent
boolean
C0679831 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
Patient History; Previous PCI with stent; Date of most recent
Item
Previous PCI with stent, Date of most recent
date
C0679831 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1513491 (UMLS CUI [1,5])
Patient History; Previous PCI without stent
Item
Previous PCI without stent
boolean
C0679831 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Patient History; Previous PCI without stent; Date of most recent
Item
Previous PCI without stent, Date of most recent
date
C0679831 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
Patient History; CABG Surgery
Item
CABG Surgery
boolean
C0679831 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Patient History; CABG Surgery, Date of most recent
Item
CABG Surgery, Date of most recent
date
C0679831 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
Patient History; CABG Surgery, Date of most recent
Item
CABG Surgery, Date of most recent
date
C0679831 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
Item
Other evidence of Coronary Artery Disease (CAD)
text
C0679831 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Patient History;
Code List
Other evidence of Coronary Artery Disease (CAD)
CL Item
No (No)
CL Item
Yes - Chronic stable angina (Yes - Chronic stable angina)
CL Item
Yes - Positive stress test (Yes - Positive stress test)
CL Item
Yes - Cardiac catheterization showing > 50% stenosis in at least 1 major coronary artery (Yes - Cardiac catheterization showing > 50% stenosis in at least 1 major coronary artery)
CL Item
Yes - Other objective evidence (specify) (Yes - Other objective evidence (specify))
Patient History; Family history; Coronary Artery Disease, Early-onset
Item
Family history of early onset CAD
boolean
C0679831 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C1956346 (UMLS CUI [1,3])
C1833334 (UMLS CUI [1,4])
Patient History; Stroke
Item
Stroke
boolean
C0679831 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
Patient History; Stroke; Date in time; most recent
Item
Stroke, Date of most recent
date
C0679831 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
Patient History; Peripheral arterial disease
Item
Peripheral arterial disease
boolean
C0679831 (UMLS CUI [1,1])
C1704436 (UMLS CUI [1,2])
Item
Hypertension
text
C0679831 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
Patient History; Hypertension
Code List
Hypertension
CL Item
No (No)
CL Item
Yes - treated medically (Yes - treated medically)
CL Item
Yes - not treated medically (Yes - not treated medically)
Item
Heart Failure
text
C0679831 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Patient History; Hypertension
Code List
Heart Failure
CL Item
No (No)
CL Item
Yes (give Killip Class at entry) (Yes (give Killip Class at entry))
Item
Diabetes
text
C0679831 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Patient History; Hypertension
Code List
Diabetes
CL Item
No (No)
CL Item
Yes - treated by Diet (Yes - treated by Diet)
CL Item
Yes - treated by Insulin (Yes - treated by Insulin)
CL Item
Yes - treated by Oral hypoglycemic (Yes - treated by Oral hypoglycemic)
CL Item
Yes - not treated (Yes - not treated)
Patient History; Diabetes; Date of diagnosis
Item
Diabetes, Date of first diagnosis
date
C0679831 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
Patient History; Hypercholesterolemia
Item
Hypercholesterolemia
boolean
C0679831 (UMLS CUI [1,1])
C0020443 (UMLS CUI [1,2])
Patient History; Malignant Neoplasms
Item
Cancer
boolean
C0679831 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Patient History; Malignant Neoplasms, date of diagnosis
Item
Cancer, Date of first diagnosis
date
C0679831 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
Patient History; Malignant Neoplasms, site
Item
Cancer, site
text
C0679831 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Item
Other relevant ongoing medical conditions prior to randomization
text
C0679831 (UMLS CUI [1,1])
C0243087 (UMLS CUI [1,2])
Patient History; concomitant disease
Code List
Other relevant ongoing medical conditions prior to randomization
CL Item
No (No)
CL Item
Yes (specify) (Yes (specify))
Item
Other relevant ongoing medical conditions prior to randomization
text
C0679831 (UMLS CUI [1,1])
C0243087 (UMLS CUI [1,2])
Patient History; concomitant disease
Code List
Other relevant ongoing medical conditions prior to randomization
CL Item
Never (Never)
CL Item
Current (give avg. no. of cigarettes per day and age started) (Current (give avg. no. of cigarettes per day and age started))
CL Item
Former (give avg. no. of cigarettes per day, age started and year stopped) (Former (give avg. no. of cigarettes per day, age started and year stopped))
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