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ID
13702
Beschrijving
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
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Versies (1)
- 29-02-16 29-02-16 -
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29 februari 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521
CABACS Case Report Form [surgery documentation]
- StudyEvent: ODM
Similar models
CABACS Case Report Form [surgery documentation]
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date of hospital admission
Item
Date of hospital admission
date
C0011008 (UMLS CUI [1,1])
C0184666 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,2])
pseudonymized copy
Item
Pseudonymized copy enclosed?
boolean
C3858753 (UMLS CUI [1])
Medical history
Item
Medical history and findings
boolean
C0262926 (UMLS CUI [1])
Item
Clinical severity of heart failure (NYHA-Classification)
text
C1275491 (UMLS CUI [1])
CL Item
I Normal physical capacity, asymptomatic (1)
CL Item
II symptoms under physical exertion (2)
CL Item
III symptoms under mild physical exertion (3)
CL Item
IV symptoms at rest (4)
CL Item
I. Ordinary physical activity does not cause angina (1)
CL Item
II. Slight limitation of ordinary activity (2)
CL Item
III. Marked limitation of ordinary activity (3)
CL Item
IV. Inability to carry out any physical activity without discomfort - angina syndrome may be present at rest (4)
CL Item
No (0)
CL Item
Yes, within last 48 hours (1)
CL Item
Yes,within past 21 days (2)
CL Item
Yes, longer than 21 but no longer than 91 days ago (3)
CL Item
Yes, more than 91 days ago (4)
CL Item
Yes but date of event unknown (8)
CL Item
unknown (9)
CL Item
No (0)
CL Item
Yes, within last 48 hours (1)
CL Item
Yes, within past 21 days (2)
CL Item
Yes, longer than 21 days ago (3)
CL Item
Yes, but date of event unknown (8)
CL Item
unknown (9)
CL Item
No (0)
CL Item
Yes, within last 48 hours (1)
CL Item
Yes, within past 21 days (2)
CL Item
Yes, longer than 21 days ago (3)
CL Item
Yes, date of event unknown (8)
CL Item
unknown (9)
Artificial ventilation
Item
Patient is on artificial respiration
boolean
C0035205 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
unknown (9)
CL Item
Normal sinus rhythm (1)
CL Item
Atrial fibrillation (2)
CL Item
Other (8)
Item
Patient wears an artificial cardiac pacemaker/defibrillator
text
C0030163 (UMLS CUI [1])
CL Item
No (0)
CL Item
Yes,Pacemaker (1)
CL Item
Yes,Defibrillator (2)
CL Item
A normal healthy patient (1)
CL Item
A patient with mild systemic disease (2)
CL Item
A patient with severe systemic disease (3)
CL Item
A patient with very severe systemic disease that is a constant threat to life (4)
CL Item
A moribund patient (5)
CL Item
bad or less than 30% (1)
CL Item
average or 30-50% (2)
CL Item
good or more than 50% (3)
Item
coronary angiography findings
text
C0085532 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
CL Item
no coronary heart disease (0)
CL Item
1-vessel disease (1)
CL Item
2-vessel disease (2)
CL Item
3-vessel disease (3)
CL Item
No (0)
CL Item
Yes equal to or more than 50% (1)
CL Item
unknown (9)
Previous PCI
Item
Previous percutaneous coronary intervention?
boolean
C1532338 (UMLS CUI [1])
Item
Previous heart surgery or aortic surgery
integer
C0018821 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
CL Item
number of interventions unknown, but at least one (8)
CL Item
unknown (9)
Item
Other current infection
text
C0009450 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
CL Item
none (0)
CL Item
Mediastinitis (1)
CL Item
Bacteremia (2)
CL Item
broncho-pulmonary infection (3)
CL Item
oto-laryngologic infection (4)
CL Item
florid endocarditis (5)
CL Item
Peritonitis (6)
CL Item
thoracic wound infection (7)
CL Item
pleural empyema (8)
CL Item
infection of venous puncture site (9)
CL Item
UTI (10)
CL Item
wound infection of lower extremities (11)
CL Item
HIV infection (12)
CL Item
Hepatitis b or C (13)
CL Item
other wound infection (18)
CL Item
other general infection (88)
CL Item
no (0)
CL Item
yes, only set dietary (1)
CL Item
yes, medical controlled (2)
CL Item
yes, insulin dependent (3)
CL Item
yes, untreated (4)
CL Item
unknown (9)
CL Item
no (0)
CL Item
Yes (1)
CL Item
unknown (9)
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
CL Item
No (0)
CL Item
Yes (1)
CL Item
unknown (9)
CL Item
no (0)
CL Item
Yes (1)
CL Item
unknown (9)
CL Item
No (0)
CL Item
Yes (1)
CL Item
unknown (9)
CL Item
No (0)
CL Item
Yes COPD with chronic medication (1)
CL Item
Yes COPD without chronic medication (2)
CL Item
Yes, other lung disease (8)
CL Item
unknown (9)
CL Item
No (0)
CL Item
Yes,CNS cerebrovascular (hemorrhage,ischemia) (1)
CL Item
Yes,CNS other (2)
CL Item
Yes, peripheral (3)
CL Item
Yes, combination (4)
CL Item
unknown (9)
Item
Modified Rankin Stroke Scale score if you answered the previous question with CNS-1
text
C2984908 (UMLS CUI [1])
Code List
Modified Rankin Stroke Scale score if you answered the previous question with CNS-1
CL Item
No symptoms at all (0)
CL Item
No significant disability despite symptoms; able to carry out all usual duties and activities (1)
CL Item
Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance (2)
CL Item
Moderate disability; requiring some help but able to walk without assistance (3)
CL Item
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance (4)
CL Item
Severe disability; bedridden, incontinent, and requiring constant nursing care and attention (5)
CL Item
No (0)
CL Item
Acute (1)
CL Item
Chronic (2)
Creatinine, Serum
Item
Serum creatinine preoperative
float
C0201976 (UMLS CUI [1])
Serum creatinine
Item
Serum creatinine preoperative
float
C0201976 (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])