ID
49
Description
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation. Inclusion criteria: - Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening - Require the procedure of cardioversion (electric shock to correct abnormal rhythm) - In the investigator's opinion, is likely to maintain sinus rhythm after cardioversion. - Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines. Exclusion criteria: - Previously unsuccessful electrical cardioversions - Failed to respond to any Class III antiarrhythmic drugs - Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
Keywords
Versions (2)
- 11/11/11 11/11/11 -
- 3/21/14 3/21/14 - Martin Dugas
Uploaded on
November 11, 2011
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0 Legacy
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Criteria NCT00035451 AF
Eligibility
- StudyEvent: Eligibility
Description
Exclusion criteria
Description
Previous cardioversions
Data type
boolean
Description
Antiarrhythmic drugs
Data type
boolean
Description
Qualifying arrhythmia
Data type
boolean
Description
Medical Concepts
Description
Diagnosis
Data type
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Description
AF
Data type
string
Alias
- UMLS CUI
- C0004238
- SNOMED CT 2010_0731
- 49436004
- MedDRA 13.1
- 10003658
- ICD-9-CM Version 2011
- 427.31
- ICD-10-CM Version 2010
- I48.0
- CTCAE Version 4.03
- E10081
Description
ECG
Data type
string
Alias
- UMLS CUI
- C1623258
- SNOMED CT 2010_0731
- 46825001
- MedDRA 13.1
- 10014084
Description
Therapeutic procedure
Data type
string
Alias
- UMLS CUI
- C0087111
Description
Cardioversion
Data type
string
Alias
- UMLS CUI
- C0013778
- SNOMED CT 2010_0731
- 250980009
- MedDRA 13.1
- 10007661
- LOINC Version 232
- LP97905-1
Description
Use of anticoagulation
Data type
string
Alias
- UMLS CUI
- C0449867
- SNOMED CT 2010_0731
- 260678004
Description
Pharmaceutical Preparations
Data type
string
Alias
- UMLS CUI
- C0013227
Description
Antiarrhythmic drug
Data type
string
Alias
- UMLS CUI
- C0003195
- SNOMED CT 2010_0731
- 67507000
Description
Cardiac Arrhythmia
Data type
string
Alias
- UMLS CUI
- C0003811
- SNOMED CT 2010_0731
- 44808001
- MedDRA 13.1
- 10003119
- ICD-10-CM Version 2010
- I49.9
- ICD-9-CM Version 2011
- 427.9
Similar models
Eligibility
- StudyEvent: Eligibility
439401001 (SNOMED CT 2010_0731)
49436004 (SNOMED CT 2010_0731)
10003658 (MedDRA 13.1)
427.31 (ICD-9-CM Version 2011)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE Version 4.03)
46825001 (SNOMED CT 2010_0731)
10014084 (MedDRA 13.1)
250980009 (SNOMED CT 2010_0731)
10007661 (MedDRA 13.1)
LP97905-1 (LOINC Version 232)
260678004 (SNOMED CT 2010_0731)
67507000 (SNOMED CT 2010_0731)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
I49.9 (ICD-10-CM Version 2010)
427.9 (ICD-9-CM Version 2011)