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
UMLS CUI [1,2]
C0027051
Cardiac marker enzymes used for laboratory verification
Description

Cardiac marker enzymes

Data type

text

Alias
UMLS CUI [1]
C0443763
Highest level of cardiac marker enzyme
Description

Highest level of cardiac marker enzyme

Data type

float

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

Units used for measurement

Data type

text

Alias
UMLS CUI [1]
C1519795
Upper Limit of Normal for this marker enzyme
Description

Upper Limit of Normal

Data type

float

Alias
UMLS CUI [1]
C1519815
Unit of measure for ULN
Description

Unit of measure

Data type

text

Alias
UMLS CUI [1]
C1519795
Clinical symptoms of cardiac ischemia
Description

Myocardial Ischemia

Data type

integer

Alias
UMLS CUI [1]
C0151744
ST elevation in ECG
Description

ST elevation

Data type

integer

Alias
UMLS CUI [1]
C0520886
Development of pathological Q waves in the ECG
Description

Pathological Q wave

Data type

integer

Alias
UMLS CUI [1]
C0429090
Cardiac dyskinesia or ventricular asynergy
Description

Cardiac dyskinesia or ventricular asynergy

Data type

integer

Alias
UMLS CUI [1]
C0232168
UMLS CUI [2]
C0232171
Other relevant information,please specify
Description

Other relevant information

Data type

text

Alias
UMLS CUI [1]
C0517287
Correlation with trial procedure CABG +/- CEA
Description

Correlation

Data type

integer

Alias
UMLS CUI [1]
C1707520
Outcome
Description

Outcome

Data type

integer

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

Date of death

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011065
Date of completion of this form
Description

Date of completion

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

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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