ID

13795

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2016-03-07 2016-03-07 -
Uppladdad den

7 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Outcome event technical failure/restenosis Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

Engelsk

CABACS Case Report Form [Outcome event technical failure/restenosis]

1 Formulär  
Endpoint event "technical failure/restenosis"
Beskrivning

Endpoint event "technical failure/restenosis"

Patient ID
Beskrivning

Patient Study ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of diagnosis
Beskrivning

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

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
Extent of restenosis
Beskrivning

(percentage according to ECST)

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1,1]
C0333186
UMLS CUI [1,2]
C0449279
%
Localization
Beskrivning

Localization

Datatyp

integer

Alias
UMLS CUI [1]
C0475264
Reason for restenosis
Beskrivning

Reason for restenosis

Datatyp

integer

Alias
UMLS CUI [1,1]
C0333186
UMLS CUI [1,2]
C0566251
Additional medical examination
Beskrivning

Additional medical examination

Datatyp

integer

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0940824
Additional medical examination, please specify other method used
Beskrivning

Additional medical examination

Datatyp

text

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0940824
Extent of disease confirmed?
Beskrivning

Extent of disease confirmed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449279
UMLS CUI [1,2]
C0750484
Symptomatic technical failure
Beskrivning

Symptomatic

Datatyp

integer

Alias
UMLS CUI [1]
C0231220
Treatment
Beskrivning

Treatment

Datatyp

integer

Alias
UMLS CUI [1]
C0087111
Treatment
Beskrivning

Treatment

Datatyp

integer

Alias
UMLS CUI [1]
C0087111
Date of repeated surgery or Percutaneous Transluminal Angioplasty/Stent
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0035110
Correlation with trial procedure CABG +/- CEA
Beskrivning

Correlation

Datatyp

integer

Alias
UMLS CUI [1]
C1707520
Outcome
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
Other relevant information,please specify
Beskrivning

Other relevant information

Datatyp

text

Alias
UMLS CUI [1]
C0517287
Date of completion of this form
Beskrivning

Date of completion

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beskrivning

Name of Investigator

Datatyp

text

Alias
UMLS CUI [1]
C0008961
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Similar models

CABACS Case Report Form [Outcome event technical failure/restenosis]

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Endpoint event "technical failure/restenosis"
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date of diagnosis
Item
Date of diagnosis
date
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Extent of restenosis
Item
Extent of restenosis
integer
C0333186 (UMLS CUI [1,1])
C0449279 (UMLS CUI [1,2])
Item
Localization
integer
C0475264 (UMLS CUI [1])
Localization
Code List
Localization
CL Item
right (1)
CL Item
left (2)
Item
Reason for restenosis
integer
C0333186 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for restenosis
Code List
Reason for restenosis
CL Item
hyperplasia of tunica intima (1)
CL Item
atherosclerotic plaque (2)
CL Item
dissection of vessel (3)
CL Item
thrombotic event (4)
CL Item
hematoma (5)
CL Item
intervention termination (6)
CL Item
unknown (7)
Item
Additional medical examination
integer
C0582103 (UMLS CUI [1,1])
C0940824 (UMLS CUI [1,2])
Additional medical examination
Code List
Additional medical examination
CL Item
CTA-computed angiography (1)
CL Item
MRA- magnetic resonance angiography  (2)
CL Item
DSA-digital subtraction angiography (3)
CL Item
Other (specify) (4)
Additional medical examination
Item
Additional medical examination, please specify other method used
text
C0582103 (UMLS CUI [1,1])
C0940824 (UMLS CUI [1,2])
Extent of disease confirmed
Item
Extent of disease confirmed?
boolean
C0449279 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Item
Symptomatic technical failure
integer
C0231220 (UMLS CUI [1])
Symptomatic
Code List
Symptomatic technical failure
CL Item
No (0)
CL Item
TIA/Amaurosis (1)
CL Item
cerebrovascular accident (please fill in outcome event form "Stroke") (2)
Item
Treatment
integer
C0087111 (UMLS CUI [1])
Treatment
Code List
Treatment
CL Item
No (0)
CL Item
Yes (please fill in SAE form) (1)
Item
Treatment
integer
C0087111 (UMLS CUI [1])
Treatment
Code List
Treatment
CL Item
Percutaneous Transluminal Angioplasty/Stent (1)
CL Item
Repeated surgical procedure (2)
Date
Item
Date of repeated surgery or Percutaneous Transluminal Angioplasty/Stent
date
C0011008 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
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)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
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)
Other relevant information
Item
Other relevant information,please specify
text
C0517287 (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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