ID

13795

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.03.16 07.03.16 -
Hochgeladen am

7. März 2016

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Endpoint event "technical failure/restenosis"
Beschreibung

Endpoint event "technical failure/restenosis"

Patient ID
Beschreibung

Patient Study ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of diagnosis
Beschreibung

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

Datentyp

date

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

(percentage according to ECST)

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0333186
UMLS CUI [1,2]
C0449279
%
Localization
Beschreibung

Localization

Datentyp

integer

Alias
UMLS CUI [1]
C0475264
Reason for restenosis
Beschreibung

Reason for restenosis

Datentyp

integer

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

Additional medical examination

Datentyp

integer

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

Additional medical examination

Datentyp

text

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

Extent of disease confirmed

Datentyp

boolean

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

Symptomatic

Datentyp

integer

Alias
UMLS CUI [1]
C0231220
Treatment
Beschreibung

Treatment

Datentyp

integer

Alias
UMLS CUI [1]
C0087111
Treatment
Beschreibung

Treatment

Datentyp

integer

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

Date

Datentyp

date

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

Correlation

Datentyp

integer

Alias
UMLS CUI [1]
C1707520
Outcome
Beschreibung

Outcome

Datentyp

integer

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

Other relevant information

Datentyp

text

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

Date of completion

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beschreibung

Name of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C0008961
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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