ID

13796

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

Versions (1)
  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 death/SAE Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

English

CABACS Case Report Form [Outcome event death/SAE]

1 forms  
Endpoint event "death/SAE"
Description

Endpoint event "death/SAE"

Patient ID
Description

Time frame for SAE: 30 days post-OP; Time frame for death notification:until last follow up Study:CABACS-Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis Indication:Carotid stenosis Sponsor:University hospital Essen Please fill in completely and legibly

Data type

text

Alias
UMLS CUI [1]
C2348585
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Patient date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Study site number
Description

Study site number

Data type

integer

Alias
UMLS CUI [1]
C2825164
SAE number
Description

SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Date of first notification about the SAE
Description

Information on notification

Data type

date

Alias
UMLS CUI [1,1]
C0422202
UMLS CUI [1,2]
C0589362
Date of follow up notification about previously documented SAE (please specify number of SAE)
Description

Information on notification

Data type

date

Alias
UMLS CUI [1,1]
C0422202
UMLS CUI [1,2]
C0589362
If you chose "Follow-up notification" please specify previously documented SAE number
Description

SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Hospital Name/medical department
Description

Hospital Name

Data type

text

Alias
UMLS CUI [1]
C2926025
Phone number of hospital or medical department
Description

Phone Number

Data type

integer

Alias
UMLS CUI [1]
C1515258
Diagnostic criteria for SAE
Description

Diagnostic criteria for SAE

Data type

integer

Alias
UMLS CUI [1,1]
C0679228
UMLS CUI [1,2]
C1519255
Correlation with trial procedure CABG +/- CEA
Description

Correlation

Data type

integer

Alias
UMLS CUI [1]
C1707520
SAE diagnosis: please specify including symptoms if possible.
Description

SAE diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
SAE Start date
Description

SAE Start date

Data type

date

Alias
UMLS CUI [1]
C2697888
SAE End Date
Description

SAE End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
Date of death if applicable
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Outcome of SAE
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Cause of death if SAE was fatal
Description

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
Date of completion of this form
Description

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

Data type

date

Alias
UMLS CUI [1]
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
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Similar models

CABACS Case Report Form [Outcome event death/SAE]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Endpoint event "death/SAE"
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Date of birth
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Study site number
Item
Study site number
integer
C2825164 (UMLS CUI [1])
SAE number
Item
SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Information on notification
Item
Date of first notification about the SAE
date
C0422202 (UMLS CUI [1,1])
C0589362 (UMLS CUI [1,2])
Information on notification
Item
Date of follow up notification about previously documented SAE (please specify number of SAE)
date
C0422202 (UMLS CUI [1,1])
C0589362 (UMLS CUI [1,2])
SAE number
Item
If you chose "Follow-up notification" please specify previously documented SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Hospital Name
Item
Hospital Name/medical department
text
C2926025 (UMLS CUI [1])
Phone Number
Item
Phone number of hospital or medical department
integer
C1515258 (UMLS CUI [1])
Item
Diagnostic criteria for SAE
integer
C0679228 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Diagnostic criteria for SAE
Code List
Diagnostic criteria for SAE
CL Item
fatal outcome (1)
CL Item
life threatening event (2)
CL Item
lead to hospitalization or prolonged hospitalization (3)
CL Item
lead to permanent or significant disability/invalidity (4)
CL Item
congenital abnormality or birth defect (5)
CL Item
longterm artificial respiration 30 days after CABG/CAE (6)
Item
Correlation with trial procedure CABG +/- CEA
integer
C1707520 (UMLS CUI [1])
Correlation
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)
SAE diagnosis
Item
SAE diagnosis: please specify including symptoms if possible.
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
SAE Start date
Item
SAE Start date
date
C2697888 (UMLS CUI [1])
SAE End Date
Item
SAE End Date
date
C2697886 (UMLS CUI [1])
Date of death
Item
Date of death if applicable
date
C1148348 (UMLS CUI [1])
Item
Outcome of SAE
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome of SAE
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)
Cause of death
Item
Cause of death if SAE was fatal
text
C0007465 (UMLS CUI [1])
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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