ID

28733

Beschrijving

Investigation of the Athero-Protective Effects of Clopidogrel; ODM derived from: https://clinicaltrials.gov/show/NCT01283282

Link

https://clinicaltrials.gov/show/NCT01283282

Trefwoorden

Versies (1)
  1. 29-01-18 29-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT01283282

Engels

Eligibility Coronary Artery Disease NCT01283282

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or females without child bearing potential aged 21-80 years
Beschrijving

Gender | Childbearing Potential Absent | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0001779
known coronary artery disease by angiogram or documented myocardial infarction.
Beschrijving

Coronary Artery Disease Angiogram | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0002978
UMLS CUI [2]
C0027051
able to provide written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treated with clopidogrel or ticlodipine in the previous 3 months
Beschrijving

Clopidogrel | Ticlopidine

Datatype

boolean

Alias
UMLS CUI [1]
C0070166
UMLS CUI [2]
C0040207
age < 21 or >80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
premenopausal females with potential for pregnancy
Beschrijving

Premenopausal state Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C3831118
allergy to clopidogrel or aspirin
Beschrijving

Hypersensitivity clopidogrel | Aspirin allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0070166
UMLS CUI [2]
C0004058
initiation or change in dose of any concomitant medical therapy within 2 months before the study
Beschrijving

Concomitant Therapy Initiation | Concomitant Therapy Medication dose changed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C1704686
UMLS CUI [2,1]
C1707479
UMLS CUI [2,2]
C1608430
uncontrolled hypertension with bp>180 mmhg systolic and >120 mmhg diastolic
Beschrijving

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
treated with coumadin therapy
Beschrijving

Coumadin

Datatype

boolean

Alias
UMLS CUI [1]
C0699129
intolerance or allergy to statins
Beschrijving

Intolerance to Statins | Hypersensitivity Statins

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0360714
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0360714
acute infection in previous 4 weeks
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
history of substance abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
uninterpretable pat test
Beschrijving

Tonometry Arterial Peripheral | Test Uninterpretable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040420
UMLS CUI [1,2]
C0221464
UMLS CUI [1,3]
C0205100
UMLS CUI [2,1]
C0039593
UMLS CUI [2,2]
C3897243
current neoplasm
Beschrijving

Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C0027651
chronic renal failure [creatinine > 2.5 mg/dl] or liver failure (liver enzymes >2x normal)
Beschrijving

Kidney Failure, Chronic | Creatinine measurement, serum | Liver Failure | Elevated liver enzymes

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0085605
UMLS CUI [4]
C0235996
acute coronary syndrome, heart failure, cva, coronary intervention within 3 months
Beschrijving

Acute Coronary Syndrome | Heart failure | Cerebrovascular accident | Intervention Coronary

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C1522318
known aortic stenosis, hypertrophic cardiomyopathy, symptomatic heart failure.
Beschrijving

Aortic Stenosis | Hypertrophic Cardiomyopathy | Heart failure Symptomatic

Datatype

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2]
C0007194
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0231220
inability to give informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
inability to return to emory for follow-up
Beschrijving

Follow-up Availability Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Coronary Artery Disease NCT01283282

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Childbearing Potential Absent | Age
Item
male or females without child bearing potential aged 21-80 years
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Coronary Artery Disease Angiogram | Myocardial Infarction
Item
known coronary artery disease by angiogram or documented myocardial infarction.
boolean
C1956346 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Informed Consent
Item
able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Clopidogrel | Ticlopidine
Item
treated with clopidogrel or ticlodipine in the previous 3 months
boolean
C0070166 (UMLS CUI [1])
C0040207 (UMLS CUI [2])
Age
Item
age < 21 or >80 years
boolean
C0001779 (UMLS CUI [1])
Premenopausal state Childbearing Potential
Item
premenopausal females with potential for pregnancy
boolean
C0232969 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Hypersensitivity clopidogrel | Aspirin allergy
Item
allergy to clopidogrel or aspirin
boolean
C0020517 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
Concomitant Therapy Initiation | Concomitant Therapy Medication dose changed
Item
initiation or change in dose of any concomitant medical therapy within 2 months before the study
boolean
C1707479 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C1608430 (UMLS CUI [2,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension with bp>180 mmhg systolic and >120 mmhg diastolic
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Coumadin
Item
treated with coumadin therapy
boolean
C0699129 (UMLS CUI [1])
Intolerance to Statins | Hypersensitivity Statins
Item
intolerance or allergy to statins
boolean
C1744706 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0360714 (UMLS CUI [2,2])
Communicable Disease
Item
acute infection in previous 4 weeks
boolean
C0009450 (UMLS CUI [1])
Substance Use Disorders
Item
history of substance abuse
boolean
C0038586 (UMLS CUI [1])
Tonometry Arterial Peripheral | Test Uninterpretable
Item
uninterpretable pat test
boolean
C0040420 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C0039593 (UMLS CUI [2,1])
C3897243 (UMLS CUI [2,2])
Neoplasm
Item
current neoplasm
boolean
C0027651 (UMLS CUI [1])
Kidney Failure, Chronic | Creatinine measurement, serum | Liver Failure | Elevated liver enzymes
Item
chronic renal failure [creatinine > 2.5 mg/dl] or liver failure (liver enzymes >2x normal)
boolean
C0022661 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0085605 (UMLS CUI [3])
C0235996 (UMLS CUI [4])
Acute Coronary Syndrome | Heart failure | Cerebrovascular accident | Intervention Coronary
Item
acute coronary syndrome, heart failure, cva, coronary intervention within 3 months
boolean
C0948089 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C1522318 (UMLS CUI [4,2])
Aortic Stenosis | Hypertrophic Cardiomyopathy | Heart failure Symptomatic
Item
known aortic stenosis, hypertrophic cardiomyopathy, symptomatic heart failure.
boolean
C0003507 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Follow-up Availability Unable
Item
inability to return to emory for follow-up
boolean
C3274571 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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