ID

13703

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. 2/29/16 2/29/16 -
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February 29, 2016

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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 [surgery:basic data]

1 forms  
Surgery documentation
Description

Surgery documentation

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Number of surgical procedures, which number is this current procedure?
Description

Number of surgical procedures

Data type

integer

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0449788
Date of surgery
Description

Date of surgery

Data type

date

Alias
UMLS CUI [1]
C0011008
Category of surgical procedure: coronary surgery
Description

Category of surgical procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0543467
Category of surgical procedure: aortic valve surgery
Description

Category of surgical procedure

Data type

text

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0543467
Category of surgical procedure: other surgical procedure
Description

Category of surgical procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0543467
Surgical procedure:OPS-Code
Description

Surgical procedure

Data type

text

Alias
UMLS CUI [1]
C0543467
Urgency of procedure
Description

Urgency

Data type

integer

Nitrates preoperative
Description

Nitrates

Data type

boolean

Alias
UMLS CUI [1]
C0017887
Elevated troponin levels
Description

Troponin

Data type

boolean

Alias
UMLS CUI [1]
C0523952
Inotropic agent preoperative
Description

Inotropic agent

Data type

boolean

Alias
UMLS CUI [1]
C0304509
Mechanical circulatory support
Description

Mechanical circulatory support

Data type

text

Alias
UMLS CUI [1]
C3274791
Wound contamination classifcation (according to definition by CDC)
Description

Wundkontaminationsklassifikation

Data type

integer

Alias
UMLS CUI [1]
C1629491
Type of surgical procedure
Description

Type of surgical procedure

Data type

integer

Alias
UMLS CUI [1]
C0679638
Surgical approach
Description

Surgical approach

Data type

integer

Alias
UMLS CUI [1]
C0449446
Operative time: from first incision to suture
Description

Operative time

Data type

time

Alias
UMLS CUI [1]
C3494201
Bypass time
Description

Bypass time

Data type

time

Alias
UMLS CUI [1,1]
C0741847
UMLS CUI [1,2]
C0040223
Aortic clamp time in minutes from placement to removal of aortic cross clamp
Description

Aortic clamp time (in minutes)

Data type

integer

Measurement units
  • Minutes
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0578559
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0578561
Minutes
Number of grafts
Description

Number of grafts

Data type

integer

Alias
UMLS CUI [1]
C1260596
Type of Graft(s)
Description

Type of Graft

Data type

text

Alias
UMLS CUI [1]
C0449494
Count of central anastomoses
Description

Central anastomosis

Data type

integer

Alias
UMLS CUI [1]
C3164806
Number of peripheral arterial anastomoses
Description

Peripheral arterial anastomosis

Data type

integer

Alias
UMLS CUI [1,1]
C0205100
UMLS CUI [1,2]
C0398035
Number of peripheral venous anastomoses
Description

Peripheral venous anastomosis

Data type

integer

Alias
UMLS CUI [1,1]
C0205100
UMLS CUI [1,2]
C0450432
Endarterectomy with thrombectomy
Description

Endarterectomy with thrombectomy

Data type

integer

Alias
UMLS CUI [1]
C0863670
Coronary arteries surgically treated
Description

Coronary arteries surgical procedure

Data type

integer

Alias
UMLS CUI [1]
C0190188
Other surgical procedure on coronary arteries
Description

Other surgical procedure on coronary arteries

Data type

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205394
Hypothermia
Description

Hypothermia

Data type

boolean

Alias
UMLS CUI [1]
C0150255
If hypothermia was induced, please specify body temperature during hypothermia
Description

Hypothermia

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0150255
°C
Manipulation of arteria ascendens
Description

Manipulation of arteria ascendens

Data type

boolean

Alias
UMLS CUI [1,1]
C1185917
UMLS CUI [1,2]
C0185111
If "yes" please specify number of central anastomoses
Description

Number of central anastomoses

Data type

integer

Alias
UMLS CUI [1,1]
C3164806
UMLS CUI [1,2]
C0449788
Application of clamp
Description

Application of clamp

Data type

integer

Alias
UMLS CUI [1]
C1444194
If no manipulation of arteria ascendens, bypass graft:T-Graft
Description

Bypass Graft

Data type

integer

Alias
UMLS CUI [1]
C0185098
Intraoperative epiaortic ultrasonography, if "yes" please fill in optional form
Description

Intraoperative epiaortic ultrasonography

Data type

boolean

Alias
UMLS CUI [1]
C2315763
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 [surgery:basic data]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Surgery documentation
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Number of surgical procedures
Item
Number of surgical procedures, which number is this current procedure?
integer
C0543467 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Date of surgery
Item
Date of surgery
date
C0011008 (UMLS CUI [1])
Category of surgical procedure
Item
Category of surgical procedure: coronary surgery
boolean
C0683312 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item
Category of surgical procedure: aortic valve surgery
text
C0683312 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Category of surgical procedure
Code List
Category of surgical procedure: aortic valve surgery
CL Item
no (0)
CL Item
yes, conventional surgical procedure (1)
CL Item
yes, catheter supported endovascular (2)
CL Item
yes,catheter supported transapically (3)
Category of surgical procedure
Item
Category of surgical procedure: other surgical procedure
boolean
C0683312 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Surgical procedure
Item
Surgical procedure:OPS-Code
text
C0543467 (UMLS CUI [1])
Item
Urgency of procedure
integer
Urgency
Code List
Urgency of procedure
CL Item
elective (1)
CL Item
urgent (2)
CL Item
emergency (3)
CL Item
resuscitation/ultima ratio (4)
Nitrates
Item
Nitrates preoperative
boolean
C0017887 (UMLS CUI [1])
Troponin
Item
Elevated troponin levels
boolean
C0523952 (UMLS CUI [1])
Inotropic agent
Item
Inotropic agent preoperative
boolean
C0304509 (UMLS CUI [1])
Item
Mechanical circulatory support
text
C3274791 (UMLS CUI [1])
Mechanical circulatory support
Code List
Mechanical circulatory support
CL Item
No (0)
CL Item
yes, intra-aortic balloon pump (iabp) (1)
CL Item
yes, other device (2)
Item
Wound contamination classifcation (according to definition by CDC)
integer
C1629491 (UMLS CUI [1])
Wundkontaminationsklassifikation
Code List
Wound contamination classifcation (according to definition by CDC)
CL Item
aseptic procedure (1)
CL Item
partially aseptic procedure (2)
CL Item
procedure with contamination (3)
CL Item
septic procedure (4)
Item
Type of surgical procedure
integer
C0679638 (UMLS CUI [1])
Type of surgical procedure
Code List
Type of surgical procedure
CL Item
with life support machine (1)
CL Item
without life support machine (2)
CL Item
change from procedure without life support machine to procedure with life support machine (3)
Item
Surgical approach
integer
C0449446 (UMLS CUI [1])
Surgical approach
Code List
Surgical approach
CL Item
conventional sternotomy (1)
CL Item
other procedure (2)
Operative time
Item
Operative time: from first incision to suture
time
C3494201 (UMLS CUI [1])
Bypass time
Item
Bypass time
time
C0741847 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Aortic clamp time (in minutes)
Item
Aortic clamp time in minutes from placement to removal of aortic cross clamp
integer
C0040223 (UMLS CUI [1,1])
C0578559 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0578561 (UMLS CUI [2,2])
Number of grafts
Item
Number of grafts
integer
C1260596 (UMLS CUI [1])
Item
Type of Graft(s)
text
C0449494 (UMLS CUI [1])
Type of Graft
Code List
Type of Graft(s)
CL Item
Vein  (1)
CL Item
Right internal thoracic artery  (2)
CL Item
Left internal thoracic artery  (3)
CL Item
Radial artery (4)
CL Item
Other grafts (5)
Central anastomosis
Item
Count of central anastomoses
integer
C3164806 (UMLS CUI [1])
Peripheral arterial anastomosis
Item
Number of peripheral arterial anastomoses
integer
C0205100 (UMLS CUI [1,1])
C0398035 (UMLS CUI [1,2])
Peripheral venous anastomosis
Item
Number of peripheral venous anastomoses
integer
C0205100 (UMLS CUI [1,1])
C0450432 (UMLS CUI [1,2])
Item
Endarterectomy with thrombectomy
integer
C0863670 (UMLS CUI [1])
Endarterectomy with thrombectomy
Code List
Endarterectomy with thrombectomy
CL Item
no (0)
CL Item
yes, left side (1)
CL Item
yes, right side (2)
CL Item
yes, bilateral (3)
Item
Coronary arteries surgically treated
integer
C0190188 (UMLS CUI [1])
Coronary arteries surgical procedure
Code List
Coronary arteries surgically treated
CL Item
LAD and/or branches (1)
CL Item
RCA and or branches (2)
CL Item
RCX and/or branches (3)
Other surgical procedure on coronary arteries
Item
Other surgical procedure on coronary arteries
boolean
C0205042 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Hypothermia
Item
Hypothermia
boolean
C0150255 (UMLS CUI [1])
Hypothermia
Item
If hypothermia was induced, please specify body temperature during hypothermia
float
C0150255 (UMLS CUI [1])
Manipulation of arteria ascendens
Item
Manipulation of arteria ascendens
boolean
C1185917 (UMLS CUI [1,1])
C0185111 (UMLS CUI [1,2])
Number of central anastomoses
Item
If "yes" please specify number of central anastomoses
integer
C3164806 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Application of clamp
integer
C1444194 (UMLS CUI [1])
Application of clamp
Code List
Application of clamp
CL Item
no (0)
CL Item
cross clamp (1)
CL Item
partial clamping (2)
Item
If no manipulation of arteria ascendens, bypass graft:T-Graft
integer
C0185098 (UMLS CUI [1])
Bypass Graft
Code List
If no manipulation of arteria ascendens, bypass graft:T-Graft
CL Item
T-Graft (1)
CL Item
other graft (2)
Intraoperative epiaortic ultrasonography
Item
Intraoperative epiaortic ultrasonography, if "yes" please fill in optional form
boolean
C2315763 (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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