Informações:
Falhas:
ID
37481
Descrição
Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden; ODM derived from: https://clinicaltrials.gov/show/NCT01356914
Link
https://clinicaltrials.gov/show/NCT01356914
Palavras-chave
Versões (1)
- 01/08/2019 01/08/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
1 de agosto de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01356914
Eligibility Atrial Fibrillation NCT01356914
- StudyEvent: Eligibility
Similar models
Eligibility Atrial Fibrillation NCT01356914
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Paroxysmal atrial fibrillation
Item
paroxysmal atrial fibrillation (af)
boolean
C0235480 (UMLS CUI [1])
Dual Chamber Pacemaker | Arrhythmia Diagnostic Appropriate
Item
programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
boolean
C2911683 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C1548787 (UMLS CUI [2,3])
C0003811 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C1548787 (UMLS CUI [2,3])
Atrial Fibrillation Percentage Artificial cardiac pacemaker
Item
1-50% af burden on pacemaker interrogation at screening.
boolean
C0004238 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0030163 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,2])
C0030163 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
women of childbearing potential (wocbp) and men must be using an acceptable method of contraception to avoid pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
persistent or permanent af.
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
C2586056 (UMLS CUI [2])
Atrial Fibrillation Percentage
Item
af burden <1% or > 50%.
boolean
C0004238 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
Nervous system disorder | Mental disorders
Item
current or history of neurological diseases and mental disorders.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0004936 (UMLS CUI [2])
Cardiac ejection fraction
Item
ejection fraction < 45%.
boolean
C0232174 (UMLS CUI [1])
Mitral Valve Dysfunction Severe | Aortic valve Dysfunction Severe
Item
severe mitral or aortic valve dysfunction.
boolean
C0026264 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0003501 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C3887504 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0003501 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Transient Ischemic Attack
Item
tia (transient ischemic attack) within last 12 months.
boolean
C0007787 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome in the last 2 months.
boolean
C0948089 (UMLS CUI [1])
Catheter ablation for atrial fibrillation
Item
previous af ablation.
boolean
C2702800 (UMLS CUI [1])
Electric Countershock
Item
cardioversion in last 3 months.
boolean
C0013778 (UMLS CUI [1])
Kidney Disease | Liver disease | Malignant Neoplasms
Item
current kidney or liver disease, or current cancer.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0023895 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
Nervous system disorder | Mental disorders
Item
history of neurological and mental disorders.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0004936 (UMLS CUI [2])
Major surgery | Cardiac Surgery
Item
major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
boolean
C0679637 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
C0018821 (UMLS CUI [2])
Laboratory Results Inconsistent Study Protocol
Item
screening lab test results outside of allowed limits per protocol.
boolean
C1254595 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0442809 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
QTcF - Fridericia's Correction Formula
Item
qtcf > 450 msec.
boolean
C1882513 (UMLS CUI [1])