ID

37482

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01395836

Stichworte

Versionen (1)
  1. 01.08.19 01.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. August 2019

DOI

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Eligibility Atrial Fibrillation NCT01395836

Englisch

Eligibility Atrial Fibrillation NCT01395836

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Informed Consent

Datentyp

boolean

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

Age

Datentyp

boolean

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

Study Subject Available Follow-up visits

Datentyp

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.
Beschreibung

Protocol Compliance

Datentyp

boolean

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

CHADS2 score

Datentyp

boolean

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

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

Datentyp

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).
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

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

Datentyp

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.
Beschreibung

Pregnancy

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT01395836

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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