ID

37613

Description

Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers; ODM derived from: https://clinicaltrials.gov/show/NCT02153437

Link

https://clinicaltrials.gov/show/NCT02153437

Keywords

Versions (1)
  1. 8/11/19 8/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02153437

English

Eligibility Atrial Fibrillation NCT02153437

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years to 85 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eligible patients will have a dual-chamber permanent pacemaker
Description

Placement of dual-chamber permanent pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C2079529
women who are not of childbearing potential
Description

Gender Childbearing Potential Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of atrial fibrillation (af) that is either
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
(i) permanent (i.e. patients are only in af and never in sinus rhythm) or
Description

Permanent atrial fibrillation | Sinus rhythm Absent

Data type

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C0232201
UMLS CUI [2,2]
C0332197
(ii) persistent (i.e. patients who's episodes of af are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded
Description

Persistent atrial fibrillation | Atrial Fibrillation Episode Duration | Requirement Intervention | Requirement Electric Countershock | Requirement Pharmacological cardioversion

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0184661
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0013778
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C1963873
history of transient ischemic attack (tia) or stroke in the last 12 months
Description

Transient Ischemic Attack | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
history of clinically significant ventricular arrhythmia (not including isolated monomorphic premature ventricular contractions (pvcs)). such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention
Description

Ventricular arrhythmia | Exception Premature ventricular contractions Isolated | Unconscious State | Emergency Electric Countershock | Unstable vital signs Requirement Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0151636
UMLS CUI [2,3]
C0205409
UMLS CUI [3]
C0041657
UMLS CUI [4,1]
C0013956
UMLS CUI [4,2]
C0013778
UMLS CUI [5,1]
C2188217
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0184661
complete heart block
Description

Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0151517
planned surgery, endovascular intervention or cardioversion within the study period
Description

Operative Surgical Procedure Planned | Endovascular intervention Planned | Electric Countershock Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0411282
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0013778
UMLS CUI [3,2]
C1301732
history of atrial fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
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Similar models

Eligibility Atrial Fibrillation NCT02153437

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years to 85 years
boolean
C0001779 (UMLS CUI [1])
Placement of dual-chamber permanent pacemaker
Item
eligible patients will have a dual-chamber permanent pacemaker
boolean
C2079529 (UMLS CUI [1])
Gender Childbearing Potential Absent
Item
women who are not of childbearing potential
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation
Item
patients with a history of atrial fibrillation (af) that is either
boolean
C0004238 (UMLS CUI [1])
Permanent atrial fibrillation | Sinus rhythm Absent
Item
(i) permanent (i.e. patients are only in af and never in sinus rhythm) or
boolean
C2586056 (UMLS CUI [1])
C0232201 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Persistent atrial fibrillation | Atrial Fibrillation Episode Duration | Requirement Intervention | Requirement Electric Countershock | Requirement Pharmacological cardioversion
Item
(ii) persistent (i.e. patients who's episodes of af are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded
boolean
C2585653 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C1963873 (UMLS CUI [5,2])
Transient Ischemic Attack | Cerebrovascular accident
Item
history of transient ischemic attack (tia) or stroke in the last 12 months
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Ventricular arrhythmia | Exception Premature ventricular contractions Isolated | Unconscious State | Emergency Electric Countershock | Unstable vital signs Requirement Intervention
Item
history of clinically significant ventricular arrhythmia (not including isolated monomorphic premature ventricular contractions (pvcs)). such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention
boolean
C0085612 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0151636 (UMLS CUI [2,2])
C0205409 (UMLS CUI [2,3])
C0041657 (UMLS CUI [3])
C0013956 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])
C2188217 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0184661 (UMLS CUI [5,3])
Complete atrioventricular block
Item
complete heart block
boolean
C0151517 (UMLS CUI [1])
Operative Surgical Procedure Planned | Endovascular intervention Planned | Electric Countershock Planned
Item
planned surgery, endovascular intervention or cardioversion within the study period
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0411282 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0013778 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Atrial Fibrillation
Item
history of atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
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