0 Ratings

ID

205

Description

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

Link

http://clinicaltrials.gov/show/NCT00255281

Keywords

  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

    Eligibility

    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

    Similar models

    Eligibility

    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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