ID

37583

Description

The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01887353

Link

https://clinicaltrials.gov/show/NCT01887353

Keywords

Versions (1)
  1. 8/8/19 8/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01887353

English

Eligibility Atrial Fibrillation NCT01887353

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or non-pregnant female > 18 years of age;
Description

Gender | Gender Pregnancy Absent | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0001779
documentation of heart failure and who are in nyha class ii or iii;
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
documented history of symptomatic af < 6 months in duration at the time of presentation, currently in af at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
Description

ATRIAL FIBRILLATION SYMPTOMATIC Duration | External elective cardioversion | Sinus rhythm Restore Successful

Data type

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C2191347
UMLS CUI [3,1]
C0232201
UMLS CUI [3,2]
C1283255
UMLS CUI [3,3]
C1272703
percutaneous coronary intervention (pci) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
Description

Percutaneous Coronary Intervention | Anticoagulation Therapy | Warfarin | Status post Electric Countershock

Data type

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0003281
UMLS CUI [3]
C0043031
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0013778
demonstration of preserved ejection fraction (ef) by echocardiography;
Description

Cardiac ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
echocardiographic evidence of impaired diastolic filling.
Description

Filling period.diastole Impaired Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0806126
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0013516
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known history of permanent or long-standing af (> 6 months);
Description

Permanent atrial fibrillation Disease length | Atrial Fibrillation Long-term Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C2586056
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0443252
UMLS CUI [2,3]
C0872146
other acutely reversible causes of af, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
Description

Causes Reversible Atrial Fibrillation | Hyperthyroidism | Pericarditis | Myocarditis | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0031046
UMLS CUI [4]
C0027059
UMLS CUI [5]
C0034065
known history of cirrhosis;
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
nyha class iv;
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
myocardial infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
Description

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
percutaneous coronary intervention (pci) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
Description

Percutaneous Coronary Intervention | Patient need for Rivaroxaban | Patient need for Dabigatran | Status post Electric Countershock

Data type

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1739768
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C2348066
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0013778
clinically significant valvular disease;
Description

Valvular disease

Data type

boolean

Alias
UMLS CUI [1]
C3258293
clinically significant pulmonary disease;
Description

Lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
stroke within 3 months prior to screening;
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
creatinine clearance < 30 ml/min as calculated by cockcroft-gault formula;
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
use of anti-arrhythmic drugs (class ia or iiic) within 3 months prior to screening;
Description

Anti-Arrhythmia Agents Class

Data type

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
concurrent use of drugs considered strong inhibitors of cyp3a;
Description

CYP3A Inhibitors Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
concurrent use of drugs considered as cyp3a inducers;
Description

CYP3A Inducers

Data type

boolean

Alias
UMLS CUI [1]
C3850044
prior treatment with ranolazine.
Description

ranolazine

Data type

boolean

Alias
UMLS CUI [1]
C0073633
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Similar models

Eligibility Atrial Fibrillation NCT01887353

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Gender Pregnancy Absent | Age
Item
male or non-pregnant female > 18 years of age;
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Heart failure New York Heart Association Classification
Item
documentation of heart failure and who are in nyha class ii or iii;
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
ATRIAL FIBRILLATION SYMPTOMATIC Duration | External elective cardioversion | Sinus rhythm Restore Successful
Item
documented history of symptomatic af < 6 months in duration at the time of presentation, currently in af at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
boolean
C0741283 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2191347 (UMLS CUI [2])
C0232201 (UMLS CUI [3,1])
C1283255 (UMLS CUI [3,2])
C1272703 (UMLS CUI [3,3])
Percutaneous Coronary Intervention | Anticoagulation Therapy | Warfarin | Status post Electric Countershock
Item
percutaneous coronary intervention (pci) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
boolean
C1532338 (UMLS CUI [1])
C0003281 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])
Cardiac ejection fraction Echocardiography
Item
demonstration of preserved ejection fraction (ef) by echocardiography;
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Filling period.diastole Impaired Echocardiography
Item
echocardiographic evidence of impaired diastolic filling.
boolean
C0806126 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Permanent atrial fibrillation Disease length | Atrial Fibrillation Long-term Disease length
Item
known history of permanent or long-standing af (> 6 months);
boolean
C2586056 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C0872146 (UMLS CUI [2,3])
Causes Reversible Atrial Fibrillation | Hyperthyroidism | Pericarditis | Myocarditis | Pulmonary Embolism
Item
other acutely reversible causes of af, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0020550 (UMLS CUI [2])
C0031046 (UMLS CUI [3])
C0027059 (UMLS CUI [4])
C0034065 (UMLS CUI [5])
Liver Cirrhosis
Item
known history of cirrhosis;
boolean
C0023890 (UMLS CUI [1])
New York Heart Association Classification
Item
nyha class iv;
boolean
C1275491 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery
Item
myocardial infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Percutaneous Coronary Intervention | Patient need for Rivaroxaban | Patient need for Dabigatran | Status post Electric Countershock
Item
percutaneous coronary intervention (pci) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
boolean
C1532338 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C1739768 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C2348066 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])
Valvular disease
Item
clinically significant valvular disease;
boolean
C3258293 (UMLS CUI [1])
Lung disease
Item
clinically significant pulmonary disease;
boolean
C0024115 (UMLS CUI [1])
Cerebrovascular accident
Item
stroke within 3 months prior to screening;
boolean
C0038454 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance < 30 ml/min as calculated by cockcroft-gault formula;
boolean
C2711451 (UMLS CUI [1])
Anti-Arrhythmia Agents Class
Item
use of anti-arrhythmic drugs (class ia or iiic) within 3 months prior to screening;
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
CYP3A Inhibitors Strong
Item
concurrent use of drugs considered strong inhibitors of cyp3a;
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
CYP3A Inducers
Item
concurrent use of drugs considered as cyp3a inducers;
boolean
C3850044 (UMLS CUI [1])
ranolazine
Item
prior treatment with ranolazine.
boolean
C0073633 (UMLS CUI [1])
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