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ID

13794

Description

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Keywords

  1. 3/7/16 3/7/16 -
Uploaded on

March 7, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    Outcome event myocardial infarction Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

    CABACS Case Report Form [Outcome event myocardial infarction]

    Endpoint event "myocardial infarction"
    Description

    Endpoint event "myocardial infarction"

    Date of myocardial infarction
    Description

    Please send via Fax within 7 days to:0201-723-947-4134

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    Cardiac marker enzymes used for laboratory verification
    Description

    Cardiac marker enzymes

    Data type

    text

    Alias
    UMLS CUI [1]
    C0443763 (Cardiac enzymes)
    SNOMED
    259669000
    LOINC
    LP98886-2
    Highest level of cardiac marker enzyme
    Description

    Highest level of cardiac marker enzyme

    Data type

    float

    Alias
    UMLS CUI [1]
    C0741921 (Cardiac enzymes increased)
    Units used for measurement of cardiac marker enzymes
    Description

    Units used for measurement

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Upper Limit of Normal for this marker enzyme
    Description

    Upper Limit of Normal

    Data type

    float

    Alias
    UMLS CUI [1]
    C1519815 (Upper Limit of Normal)
    Unit of measure for ULN
    Description

    Unit of measure

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Clinical symptoms of cardiac ischemia
    Description

    Myocardial Ischemia

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0151744 (Myocardial Ischemia)
    SNOMED
    414545008
    ST elevation in ECG
    Description

    ST elevation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0520886 (ST segment elevation (finding))
    SNOMED
    164931005
    Development of pathological Q waves in the ECG
    Description

    Pathological Q wave

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0429090 (Pathological Q wave)
    SNOMED
    164918000
    Cardiac dyskinesia or ventricular asynergy
    Description

    Cardiac dyskinesia or ventricular asynergy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0232168 (Cardiac dyskinesia)
    SNOMED
    25437005
    UMLS CUI [2]
    C0232171 (Ventricular asynergy)
    SNOMED
    195675009
    Other relevant information,please specify
    Description

    Other relevant information

    Data type

    text

    Alias
    UMLS CUI [1]
    C0517287 (Identifies relevant information)
    Correlation with trial procedure CABG +/- CEA
    Description

    Correlation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1707520 (Correlation)
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    If myocardial infarction was fatal,please specify the date of death
    Description

    Date of death

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0011065 (Cessation of life)
    SNOMED
    419620001
    Date of completion of this form
    Description

    Date of completion

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Signature by investigator
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Name of Investigator
    Description

    Name of Investigator

    Data type

    text

    Alias
    UMLS CUI [1]
    C0008961 (Clinical Investigators)

    Similar models

    CABACS Case Report Form [Outcome event myocardial infarction]

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Endpoint event "myocardial infarction"
    Date of myocardial infarction
    Item
    Date of myocardial infarction
    date
    C0011008 (UMLS CUI [1,1])
    C0027051 (UMLS CUI [1,2])
    Item
    Cardiac marker enzymes used for laboratory verification
    text
    C0443763 (UMLS CUI [1])
    Code List
    Cardiac marker enzymes used for laboratory verification
    CL Item
    Troponin T (1)
    CL Item
    Troponin I (2)
    CL Item
    Creatine Kinase (3)
    CL Item
    Creatine Kinase MB (4)
    Highest level of cardiac marker enzyme
    Item
    Highest level of cardiac marker enzyme
    float
    C0741921 (UMLS CUI [1])
    Units used for measurement
    Item
    Units used for measurement of cardiac marker enzymes
    text
    C1519795 (UMLS CUI [1])
    Upper Limit of Normal
    Item
    Upper Limit of Normal for this marker enzyme
    float
    C1519815 (UMLS CUI [1])
    Unit of measure
    Item
    Unit of measure for ULN
    text
    C1519795 (UMLS CUI [1])
    Item
    Clinical symptoms of cardiac ischemia
    integer
    C0151744 (UMLS CUI [1])
    Code List
    Clinical symptoms of cardiac ischemia
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    unknown (3)
    Item
    ST elevation in ECG
    integer
    C0520886 (UMLS CUI [1])
    Code List
    ST elevation in ECG
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    unknown (3)
    Item
    Development of pathological Q waves in the ECG
    integer
    C0429090 (UMLS CUI [1])
    Code List
    Development of pathological Q waves in the ECG
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    unknown (3)
    Item
    Cardiac dyskinesia or ventricular asynergy
    integer
    C0232168 (UMLS CUI [1])
    C0232171 (UMLS CUI [2])
    Code List
    Cardiac dyskinesia or ventricular asynergy
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    unknown (3)
    Other relevant information
    Item
    Other relevant information,please specify
    text
    C0517287 (UMLS CUI [1])
    Item
    Correlation with trial procedure CABG +/- CEA
    integer
    C1707520 (UMLS CUI [1])
    Code List
    Correlation with trial procedure CABG +/- CEA
    CL Item
    definite (1)
    CL Item
    probable (2)
    CL Item
    possible (3)
    CL Item
    not likely (4)
    CL Item
    no correlation (5)
    CL Item
    can not be assessed (6)
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Code List
    Outcome
    CL Item
    recovered (1)
    CL Item
    not yet recovered (2)
    CL Item
    improvement (3)
    CL Item
    recovered with sequelae (4)
    CL Item
    fatal (5)
    CL Item
    unknown (6)
    Date of death
    Item
    If myocardial infarction was fatal,please specify the date of death
    date
    C0011008 (UMLS CUI [1,1])
    C0011065 (UMLS CUI [1,2])
    Date of completion
    Item
    Date of completion of this form
    date
    C0011008 (UMLS CUI [1])
    Signature
    Item
    Signature by investigator
    text
    C1519316 (UMLS CUI [1])
    Name of Investigator
    Item
    Name of Investigator
    text
    C0008961 (UMLS CUI [1])

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