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ID

13669

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

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Versions (1)
  1. 2/26/16 2/26/16 -
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February 26, 2016

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Creative Commons BY-NC 3.0
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    Patient randomization form Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

    English

    CABACS Case Report Form [Patient randomization form]

    1 forms  
    Patient randomization form
    Description

    Patient randomization form

    Patient ID
    Description

    Patient Study ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Are all inclusion criteria met?
    Description

    Verification of eligibility criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1516637
    UMLS CUI [1,2]
    C1711411
    Have any exclusion criteria been answered with yes?
    Description

    Verification of eligibility criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1516637
    UMLS CUI [1,2]
    C1711411
    Informed consent signed
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Date of informed consent
    Description

    Date of informed consent

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0021430
    Study site number
    Description

    Study site

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2825164
    Age
    Description

    Age

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001779
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Modified rankin scale score
    Description

    Modified rankin scale

    Data type

    text

    Alias
    UMLS CUI [1]
    C2984908
    Please enter a phone number for further questions that might occur
    Description

    Phone contact

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3476398
    Please enter a valid fax number
    Description

    Fax number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1549619
    Date of Randomization
    Description

    Date of Randomization

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    Signature by investigator
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519316
    Name of Investigator
    Description

    Name of Investigator

    Data type

    text

    Alias
    UMLS CUI [1]
    C0008961
    Patient has been randomized into following group
    Description

    Please send this form via FAX 049-201-92239-310 or 049-201-723-5933. Office time from 9AM until 4PM. You will receive the result of randomization within three hours if form is sent before 4PM. Otherwise the next morning. Shouldn´t you receive an answer after 3 hours, please give us a call. Anja Marr,Center for clinical trials in Essen, c/o Institute for medical informatics,biometrics and epidemiology, University Hospital Essen, Hufelandstraße 55, 45122 Essen,Germany

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034656
    Date of Randomization
    Description

    Date of Randomization

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    Signature by randomizing Person
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519316
    Name of randomizing person
    Description

    Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027365
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    Similar models

    CABACS Case Report Form [Patient randomization form]

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient randomization form
    Patient Study ID
    Item
    Patient ID
    text
    C2348585 (UMLS CUI [1])
    Verification of eligibility criteria
    Item
    Are all inclusion criteria met?
    boolean
    C1516637 (UMLS CUI [1,1])
    C1711411 (UMLS CUI [1,2])
    Verification of eligibility criteria
    Item
    Have any exclusion criteria been answered with yes?
    boolean
    C1516637 (UMLS CUI [1,1])
    C1711411 (UMLS CUI [1,2])
    Informed consent
    Item
    Informed consent signed
    boolean
    C0021430 (UMLS CUI [1])
    Date of informed consent
    Item
    Date of informed consent
    date
    C0011008 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Study site
    Item
    Study site number
    integer
    C2825164 (UMLS CUI [1])
    Item
    Age
    text
    C0001779 (UMLS CUI [1])
    Age
    Code List
    Age
    CL Item
    <60years (1)
    CL Item
    ≥ 60 Jahre (2)
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    male (1)
    CL Item
    female (2)
    Item
    Modified rankin scale score
    text
    C2984908 (UMLS CUI [1])
    Modified rankin scale
    Code List
    Modified rankin scale score
    CL Item
    0-1 (1)
    CL Item
    2-3 (2)
    Phone contact
    Item
    Please enter a phone number for further questions that might occur
    integer
    C3476398 (UMLS CUI [1])
    Fax number
    Item
    Please enter a valid fax number
    integer
    C1549619 (UMLS CUI [1])
    Date of Randomization
    Item
    Date of Randomization
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Signature
    Item
    Signature by investigator
    text
    C1519316 (UMLS CUI [1])
    Name of Investigator
    Item
    Name of Investigator
    text
    C0008961 (UMLS CUI [1])
    Item
    Patient has been randomized into following group
    text
    C0034656 (UMLS CUI [1])
    Randomization
    Code List
    Patient has been randomized into following group
    CL Item
    CABG with CEA (1)
    CL Item
    CABG without CEA (2)
    Date of Randomization
    Item
    Date of Randomization
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Signature
    Item
    Signature by randomizing Person
    text
    C1519316 (UMLS CUI [1])
    Name
    Item
    Name of randomizing person
    text
    C0027365 (UMLS CUI [1])
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