ID

37482

Description

Management of New-Onset Postoperative Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01395836

Link

https://clinicaltrials.gov/show/NCT01395836

Keywords

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

See clinicaltrials.gov

Uploaded on

August 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01395836

English

Eligibility Atrial Fibrillation NCT01395836

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is able and willing to sign and date the patient consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subject is 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject is expected to remain available for at least 12 months of follow- up visits.
Description

Study Subject Available Follow-up visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0589121
subject is willing to comply with the protocol, including follow-up visits, medication compliance, carelink transmissions, and randomization assignment.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
subject has a chads2 score of ≥ 1.
Description

CHADS2 score

Data type

boolean

Alias
UMLS CUI [1]
C2585876
subject is hospitalized post isolated cabg or is within 72 hours post hospital discharge from a cabg procedure.
Description

Hospitalization Post Coronary Artery Bypass Surgery Isolated | Coronary Artery Bypass Surgery Followed by Discharge from hospital

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0010055
UMLS CUI [1,4]
C0205409
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C0332283
UMLS CUI [2,3]
C0586003
subject has no previous history of af and has developed new-onset postoperative atrial fibrillation according to the established sts definition, which defines it as the occurrence of poaf or atrial flutter requiring treatment (i.e. beta-blockers, calcium-channel blockers, amiodarone, anticoagulation, or cardioversion).
Description

Atrial Fibrillation Previous Absent | Atrial Fibrillation Postoperative Treatment required for | Adrenergic beta-1 Receptor Antagonists | Calcium Channel Blockers | Amiodarone | Anticoagulation Therapy | Electric Countershock

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0032790
UMLS CUI [2,3]
C0332121
UMLS CUI [3]
C0304516
UMLS CUI [4]
C0006684
UMLS CUI [5]
C0002598
UMLS CUI [6]
C0003281
UMLS CUI [7]
C0013778
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a medically documented history of paroxysmal or persistent atrial fibrillation or atrial flutter.
Description

Paroxysmal atrial fibrillation | Paroxysmal atrial flutter | Persistent atrial fibrillation | Atrial Flutter Persistent

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C0741292
UMLS CUI [3]
C2585653
UMLS CUI [4,1]
C0004239
UMLS CUI [4,2]
C0205322
subject is pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Interference Research results

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C0683954
subject has previously or is scheduled to undergo valve repair or valve replacement during the course of the study.
Description

Repair of heart valve | Valve replacement | Repair of heart valve Scheduled | Valve replacement Scheduled

Data type

boolean

Alias
UMLS CUI [1]
C0190112
UMLS CUI [2]
C1410969
UMLS CUI [3,1]
C0190112
UMLS CUI [3,2]
C0205539
UMLS CUI [4,1]
C1410969
UMLS CUI [4,2]
C0205539
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Similar models

Eligibility Atrial Fibrillation NCT01395836

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subject is able and willing to sign and date the patient consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
subject is 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Study Subject Available Follow-up visits
Item
subject is expected to remain available for at least 12 months of follow- up visits.
boolean
C0681850 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Protocol Compliance
Item
subject is willing to comply with the protocol, including follow-up visits, medication compliance, carelink transmissions, and randomization assignment.
boolean
C0525058 (UMLS CUI [1])
CHADS2 score
Item
subject has a chads2 score of ≥ 1.
boolean
C2585876 (UMLS CUI [1])
Hospitalization Post Coronary Artery Bypass Surgery Isolated | Coronary Artery Bypass Surgery Followed by Discharge from hospital
Item
subject is hospitalized post isolated cabg or is within 72 hours post hospital discharge from a cabg procedure.
boolean
C0019993 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C0205409 (UMLS CUI [1,4])
C0010055 (UMLS CUI [2,1])
C0332283 (UMLS CUI [2,2])
C0586003 (UMLS CUI [2,3])
Atrial Fibrillation Previous Absent | Atrial Fibrillation Postoperative Treatment required for | Adrenergic beta-1 Receptor Antagonists | Calcium Channel Blockers | Amiodarone | Anticoagulation Therapy | Electric Countershock
Item
subject has no previous history of af and has developed new-onset postoperative atrial fibrillation according to the established sts definition, which defines it as the occurrence of poaf or atrial flutter requiring treatment (i.e. beta-blockers, calcium-channel blockers, amiodarone, anticoagulation, or cardioversion).
boolean
C0004238 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0032790 (UMLS CUI [2,2])
C0332121 (UMLS CUI [2,3])
C0304516 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
C0002598 (UMLS CUI [5])
C0003281 (UMLS CUI [6])
C0013778 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Paroxysmal atrial fibrillation | Paroxysmal atrial flutter | Persistent atrial fibrillation | Atrial Flutter Persistent
Item
subject has a medically documented history of paroxysmal or persistent atrial fibrillation or atrial flutter.
boolean
C0235480 (UMLS CUI [1])
C0741292 (UMLS CUI [2])
C2585653 (UMLS CUI [3])
C0004239 (UMLS CUI [4,1])
C0205322 (UMLS CUI [4,2])
Pregnancy
Item
subject is pregnant.
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Interference Research results
Item
subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0521102 (UMLS CUI [4,1])
C0683954 (UMLS CUI [4,2])
Repair of heart valve | Valve replacement | Repair of heart valve Scheduled | Valve replacement Scheduled
Item
subject has previously or is scheduled to undergo valve repair or valve replacement during the course of the study.
boolean
C0190112 (UMLS CUI [1])
C1410969 (UMLS CUI [2])
C0190112 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C1410969 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
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