ID

205

Description

ODM derived from http://clinicaltrials.gov/show/NCT00255281

Link

http://clinicaltrials.gov/show/NCT00255281

Keywords

Versions (2)
  1. 2/24/12 2/24/12 -
  2. 6/6/17 6/6/17 - Martin Dugas
Uploaded on

February 24, 2012

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility NCT00255281 Atrial Fibrillation

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 18 Years to 80 Years
Description

Age

Data type

boolean

Clinical indication for cardioversion of Atrial Fibrillation. Effective oral anticoagulation according to local routines or a TEE without any finding of intracardial thrombus or signs of thrombogenecity
Description

cardioversion of Atrial Fibrillation

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Clinically significant sinus and/or AV node dysfunction. Serum or plasma potassium <3.8 mmol/L or >5.0 mmol/L. QTc(Bazett) >450 ms. Any QRS duration >150 ms
Description

sinus and/or AV node dysfunction

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Cardioversion
Description

Cardioversion

Data type

string

Alias
UMLS CUI
C0013778
SNOMED CT 2010_0731
250980009
MedDRA 13.1
10007661
Atrial fibrillation
Description

AF

Data type

string

Alias
UMLS CUI
C0004238
SNOMED CT 2010_0731
49436004
MedDRA 13.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE Version 4.03
E10081
Use of anticoagulation
Description

Use of anticoagulation

Data type

string

Alias
UMLS CUI
C0449867
SNOMED CT 2010_0731
260678004
Echocardiography, Transesophageal
Description

TEE

Data type

string

Alias
UMLS CUI
C0206054
SNOMED CT 2010_0731
105376000
MedDRA 13.1
10053367
Thrombus
Description

Thrombus

Data type

string

Alias
UMLS CUI
C0087086
SNOMED CT 2010_0731
396339007
Coronary sinus rhythm disorder
Description

Sinus Node Dysfunction

Data type

string

Alias
UMLS CUI
C0428908
SNOMED CT 2010_0731
60423000
MedDRA 13.1
10040737
ICD-10-CM Version 2010
I49.8
ICD-9-CM Version 2011
427.81
Atrioventricular nodal disease
Description

Atrioventricular nodal disease

Data type

string

Alias
UMLS CUI
C1841659
Serum potassium abnormal
Description

Serum potassium abnormal

Data type

string

Alias
UMLS CUI
C0858156
MedDRA 13.1
10040377
Plasma potassium abnormal
Description

Plasma potassium abnormal

Data type

string

Alias
UMLS CUI
C0858157
MedDRA 13.1
10035408
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age 18 Years to 80 Years
boolean
cardioversion of Atrial Fibrillation
Item
Clinical indication for cardioversion of Atrial Fibrillation. Effective oral anticoagulation according to local routines or a TEE without any finding of intracardial thrombus or signs of thrombogenecity
boolean
Item Group
Exclusion Criteria
sinus and/or AV node dysfunction
Item
Clinically significant sinus and/or AV node dysfunction. Serum or plasma potassium <3.8 mmol/L or >5.0 mmol/L. QTc(Bazett) >450 ms. Any QRS duration >150 ms
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Cardioversion
Item
Cardioversion
string
C0013778 (UMLS CUI)
250980009 (SNOMED CT 2010_0731)
10007661 (MedDRA 13.1)
AF
Item
Atrial fibrillation
string
C0004238 (UMLS CUI)
49436004 (SNOMED CT 2010_0731)
10003658 (MedDRA 13.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE Version 4.03)
Use of anticoagulation
Item
Use of anticoagulation
string
C0449867 (UMLS CUI)
260678004 (SNOMED CT 2010_0731)
TEE
Item
Echocardiography, Transesophageal
string
C0206054 (UMLS CUI)
105376000 (SNOMED CT 2010_0731)
10053367 (MedDRA 13.1)
Thrombus
Item
Thrombus
string
C0087086 (UMLS CUI)
396339007 (SNOMED CT 2010_0731)
Sinus Node Dysfunction
Item
Coronary sinus rhythm disorder
string
C0428908 (UMLS CUI)
60423000 (SNOMED CT 2010_0731)
10040737 (MedDRA 13.1)
I49.8 (ICD-10-CM Version 2010)
427.81 (ICD-9-CM Version 2011)
Atrioventricular nodal disease
Item
Atrioventricular nodal disease
string
C1841659 (UMLS CUI)
Serum potassium abnormal
Item
Serum potassium abnormal
string
C0858156 (UMLS CUI)
10040377 (MedDRA 13.1)
Plasma potassium abnormal
Item
Plasma potassium abnormal
string
C0858157 (UMLS CUI)
10035408 (MedDRA 13.1)
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