ID

13720

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. 3/1/16 3/1/16 -
Uploaded on

March 1, 2016

DOI

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License

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

English

CABACS Case Report Form [carotid reconstruction]

1 forms  
Surgery documentation "CABG with CEA"
Description

Surgery documentation "CABG with CEA"

Patient ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Outcome event "technical failure":Did the carotid stenosis prove to be inoperable or could be reduced inadequately (less than 70 percent according to ECST)
Description

If yes, please fill in technical failure Outcome event form and send via FAX to study coordinator within 7 days.

Data type

boolean

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C0162643
Sequence of surgical procedures
Description

Sequence of surgical procedures

Data type

integer

Alias
UMLS CUI [1,1]
C1519249
UMLS CUI [1,2]
C0543467
Surgical procedures,OPS codes
Description

Surgical Procedures

Data type

text

Alias
UMLS CUI [1]
C0543467
General anaesthesia
Description

General Anesthesia

Data type

boolean

Alias
UMLS CUI [1]
C0002915
Regional anesthesia
Description

Regional anesthesia

Data type

boolean

Alias
UMLS CUI [1]
C0002911
Creation of shunt
Description

Creation of shunt

Data type

boolean

Alias
UMLS CUI [1]
C0813207
Endarterectomy with thrombectomy
Description

Endarterectomy with thrombectomy

Data type

integer

Alias
UMLS CUI [1]
C0863670
Endarterectomy of internal carotid artery with eversion and end-to-end anastomosis
Description

Endarterectomy of internal carotid artery with eversion and end-to-end anastomosis

Data type

boolean

Alias
UMLS CUI [1]
C1320889
Carotid interposition
Description

Carotid interposition

Data type

integer

Alias
UMLS CUI [1]
C0843316
Other surgical procedures
Description

Surgical procedures

Data type

integer

Alias
UMLS CUI [1]
C0543467
Additional intraoperative procedures/actions
Description

Additional intraoperative procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0243164
UMLS CUI [1,2]
C0940824
Time vessels have been clamped
Description

Clamp time

Data type

time

Measurement units
  • Minutes
Alias
UMLS CUI [1,1]
C1718394
UMLS CUI [1,2]
C1718391
Minutes
Neurological monitoring
Description

Neurological monitoring

Data type

boolean

Alias
UMLS CUI [1]
C0150281
Neurological monitoring:please specify
Description

Neurological monitoring

Data type

integer

Alias
UMLS CUI [1]
C0150281
Intraprocedural control
Description

Intraprocedural control

Data type

boolean

Alias
UMLS CUI [1,1]
C0585033
UMLS CUI [1,2]
C0243148
Intraprocedural control:Please specify
Description

Intraprocedural control

Data type

integer

Alias
UMLS CUI [1,1]
C0585033
UMLS CUI [1,2]
C0243148
Operative time from first incision to suture
Description

Operative time

Data type

time

Measurement units
  • Minutes
Alias
UMLS CUI [1]
C3494201
Minutes
Recurrent procedure
Description

Recurrent procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C2945760
UMLS CUI [1,2]
C0543467
Hypothermia,induced
Description

Hypothermia,induced

Data type

boolean

Alias
UMLS CUI [1]
C0020674
Hypothermia,induced: please specify body temperature
Description

Hypothermia,induced

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0020674
°C
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
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Similar models

CABACS Case Report Form [carotid reconstruction]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Surgery documentation "CABG with CEA"
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Outcome event "technical failure"
Item
Outcome event "technical failure":Did the carotid stenosis prove to be inoperable or could be reduced inadequately (less than 70 percent according to ECST)
boolean
C1705586 (UMLS CUI [1,1])
C0162643 (UMLS CUI [1,2])
Item
Sequence of surgical procedures
integer
C1519249 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Sequence of surgical procedures
Code List
Sequence of surgical procedures
CL Item
First CEA, then CABG (1)
CL Item
First CABG, then CEA (2)
Surgical Procedures
Item
Surgical procedures,OPS codes
text
C0543467 (UMLS CUI [1])
General Anesthesia
Item
General anaesthesia
boolean
C0002915 (UMLS CUI [1])
Regional anesthesia
Item
Regional anesthesia
boolean
C0002911 (UMLS CUI [1])
Creation of shunt
Item
Creation of shunt
boolean
C0813207 (UMLS CUI [1])
Item
Endarterectomy with thrombectomy
integer
C0863670 (UMLS CUI [1])
Endarterectomy with thrombectomy
Code List
Endarterectomy with thrombectomy
CL Item
no (0)
CL Item
venous patch (1)
CL Item
PTFE-Patch (2)
CL Item
polyurethane patch (3)
CL Item
dacron patch (4)
CL Item
direct suture (5)
CL Item
other (6)
Endarterectomy of internal carotid artery with eversion and end-to-end anastomosis
Item
Endarterectomy of internal carotid artery with eversion and end-to-end anastomosis
boolean
C1320889 (UMLS CUI [1])
Item
Carotid interposition
integer
C0843316 (UMLS CUI [1])
Carotid interposition
Code List
Carotid interposition
CL Item
no (0)
CL Item
vein (1)
CL Item
PTFE (2)
CL Item
Dacron (3)
CL Item
other (9)
Item
Other surgical procedures
integer
C0543467 (UMLS CUI [1])
Surgical procedures
Code List
Other surgical procedures
CL Item
no (0)
CL Item
Externa plastic (1)
CL Item
carotid-carotid bypass (2)
CL Item
other (9)
Additional intraoperative procedures
Item
Additional intraoperative procedures/actions
boolean
C0243164 (UMLS CUI [1,1])
C0940824 (UMLS CUI [1,2])
Clamp time
Item
Time vessels have been clamped
time
C1718394 (UMLS CUI [1,1])
C1718391 (UMLS CUI [1,2])
Neurological monitoring
Item
Neurological monitoring
boolean
C0150281 (UMLS CUI [1])
Item
Neurological monitoring:please specify
integer
C0150281 (UMLS CUI [1])
Neurological monitoring
Code List
Neurological monitoring:please specify
CL Item
SEP (1)
CL Item
EEG (2)
CL Item
Oxymetry (3)
CL Item
other (9)
Intraprocedural control
Item
Intraprocedural control
boolean
C0585033 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
Item
Intraprocedural control:Please specify
integer
C0585033 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
Intraprocedural control
Code List
Intraprocedural control:Please specify
CL Item
Ultrasound (1)
CL Item
Angiography (2)
CL Item
Doppler-Flowmetry (3)
CL Item
other (9)
Operative time
Item
Operative time from first incision to suture
time
C3494201 (UMLS CUI [1])
Recurrent procedure
Item
Recurrent procedure
boolean
C2945760 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Hypothermia,induced
Item
Hypothermia,induced
boolean
C0020674 (UMLS CUI [1])
Hypothermia,induced
Item
Hypothermia,induced: please specify body temperature
float
C0020674 (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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