ID

31227

Description

Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00684307

Link

https://clinicaltrials.gov/show/NCT00684307

Keywords

Versions (2)
  1. 7/30/18 7/30/18 -
  2. 7/30/18 7/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 30, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Nonvalvular Atrial Fibrillation NCT00684307

English

Eligibility Nonvalvular Atrial Fibrillation NCT00684307

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
nonvalvular af (nvaf) verified by at least two ecgs in the last year separated by at least one week.
Description

Atrial Fibrillation ECG Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0013798
UMLS CUI [1,3]
C1265611
previous cerebral ischemic attack (stroke or tia, >30 days prior to randomization)
Description

Ischemic attack cerebral | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1,1]
C0745413
UMLS CUI [1,2]
C0006104
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
previous systemic embolism.
Description

Embolism Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013922
UMLS CUI [1,2]
C0205373
symptomatic congestive heart failure (chf)
Description

Symptomatic congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0742758
impaired left ventricular systolic function
Description

Depression of left ventricular systolic function

Data type

boolean

Alias
UMLS CUI [1]
C1299337
diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
hypertension requiring anti-hypertensive treatment.
Description

Hypertensive disease Requirement Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0585941
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
af secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
Description

Atrial Fibrillation Secondary to Disease Reversible | Hyperthyroidism | Drug-induced embolism | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0205343
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0544765
UMLS CUI [4]
C0034065
known contraindication to vka treatment
Description

Medical contraindication Treatment with Vitamin K antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1096489
presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than af requiring chronic anticoagulation treatment
Description

Heart valve disease | HEART-VALVE, MECHANICAL | Endocarditis | Left ventricular aneurysm | Left ventricular thrombus | Atrial myxoma | Exception Atrial Fibrillation Requirement ANTICOAGULATION TREATMENT CHRONIC

Data type

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2]
C0493527
UMLS CUI [3]
C0014118
UMLS CUI [4]
C0519097
UMLS CUI [5]
C0587044
UMLS CUI [6]
C0151241
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0004238
UMLS CUI [7,3]
C1514873
UMLS CUI [7,4]
C0741136
conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization
Description

Condition At risk Hemorrhage Major | Intracranial Hemorrhages | Gastrointestinal Hemorrhage | Major surgery | Trauma

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0019080
UMLS CUI [1,4]
C0205164
UMLS CUI [2]
C0151699
UMLS CUI [3]
C0017181
UMLS CUI [4]
C0679637
UMLS CUI [5]
C3714660
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Similar models

Eligibility Nonvalvular Atrial Fibrillation NCT00684307

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation ECG Quantity
Item
nonvalvular af (nvaf) verified by at least two ecgs in the last year separated by at least one week.
boolean
C0004238 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Ischemic attack cerebral | Cerebrovascular accident | Transient Ischemic Attack
Item
previous cerebral ischemic attack (stroke or tia, >30 days prior to randomization)
boolean
C0745413 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Embolism Systemic
Item
previous systemic embolism.
boolean
C0013922 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Symptomatic congestive heart failure
Item
symptomatic congestive heart failure (chf)
boolean
C0742758 (UMLS CUI [1])
Depression of left ventricular systolic function
Item
impaired left ventricular systolic function
boolean
C1299337 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Hypertensive disease Requirement Antihypertensive therapy
Item
hypertension requiring anti-hypertensive treatment.
boolean
C0020538 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0585941 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Secondary to Disease Reversible | Hyperthyroidism | Drug-induced embolism | Pulmonary Embolism
Item
af secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
C0020550 (UMLS CUI [2])
C0544765 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
Medical contraindication Treatment with Vitamin K antagonist
Item
known contraindication to vka treatment
boolean
C1301624 (UMLS CUI [1,1])
C1096489 (UMLS CUI [1,2])
Heart valve disease | HEART-VALVE, MECHANICAL | Endocarditis | Left ventricular aneurysm | Left ventricular thrombus | Atrial myxoma | Exception Atrial Fibrillation Requirement ANTICOAGULATION TREATMENT CHRONIC
Item
presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than af requiring chronic anticoagulation treatment
boolean
C0018824 (UMLS CUI [1])
C0493527 (UMLS CUI [2])
C0014118 (UMLS CUI [3])
C0519097 (UMLS CUI [4])
C0587044 (UMLS CUI [5])
C0151241 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0004238 (UMLS CUI [7,2])
C1514873 (UMLS CUI [7,3])
C0741136 (UMLS CUI [7,4])
Condition At risk Hemorrhage Major | Intracranial Hemorrhages | Gastrointestinal Hemorrhage | Major surgery | Trauma
Item
conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0151699 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0679637 (UMLS CUI [4])
C3714660 (UMLS CUI [5])
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