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ID
43730
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 (3)
- 01-03-16 01-03-16 -
- 02-03-16 02-03-16 -
- 20-09-21 20-09-21 -
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20 september 2021
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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 [Day 30 post-Op]
- StudyEvent: ODM
Similar models
CABACS Case Report Form [Day 30 post-Op]
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Common carotid artery stenosis
Item
Right common carotid artery % stenosis according to ECST
integer
C0751635 (UMLS CUI [1])
Common carotid artery stenosis
Item
Left common carotid artery % stenosis according to ECST
integer
C0751635 (UMLS CUI [1])
Internal Carotid Artery Stenosis
Item
Right internal Carotid Artery % stenosis according to ECST
integer
C0340569 (UMLS CUI [1])
Internal Carotid Artery Stenosis
Item
Left internal Carotid Artery % stenosis according to ECST
integer
C0340569 (UMLS CUI [1])
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
ECG findings
Item
Any pathologic findings in ECG?
boolean
C0438154 (UMLS CUI [1])
ECG findings
Item
Please specify any pathologic ECG findings
text
C0438154 (UMLS CUI [1])
Visual impairment
Item
Did the patient experience any (transient) visual impairment (since surgery)?
boolean
C3665347 (UMLS CUI [1])
Paresthesia or hemiplegia
Item
Did the patient experience paresthesia or weakness on one side of the body (since surgery)?
boolean
C0030554 (UMLS CUI [1,1])
C0018991 (UMLS CUI [1,2])
C0018991 (UMLS CUI [1,2])
Speech disorder
Item
Did the patient experience speech disorder (since surgery)?
boolean
C0037822 (UMLS CUI [1])
New signs or symptoms
Item
Did the patient experience any new signs or symptoms (since surgery)?
boolean
C0037088 (UMLS CUI [1])
Adverse event
Item
Is at least one of the following adverse events present: cerebrovascular stroke, myocardial infaction,carotid occlusion, recurrent carotid stenosis or death? If `yes` please fill in Adverse event form and send to study coordinator within 7 days.
boolean
C0877248 (UMLS CUI [1])
Wound infection
Item
Deep wound infection
boolean
C0043241 (UMLS CUI [1])
Sepsis
Item
Sepsis
boolean
C0243026 (UMLS CUI [1])
Venous thrombosis
Item
Deep vein thrombosis
boolean
C0040053 (UMLS CUI [1])
Pulmonary Embolism
Item
Pulmonary Embolism
boolean
C0034065 (UMLS CUI [1])
Pneumonia
Item
Pneumonia
boolean
C0032285 (UMLS CUI [1])
Hemodynamic instability
Item
Severe hemodynamic instability longer than 24h
boolean
C0948268 (UMLS CUI [1])
Carotid dilatation
Item
Carotid dilatation
boolean
C0012359 (UMLS CUI [1,1])
C0007272 (UMLS CUI [1,2])
C0007272 (UMLS CUI [1,2])
Hemorrhage
Item
Carotid bleeding requiring revision
boolean
C0019080 (UMLS CUI [1])
Deterioration of comorbidity
Item
Deterioration of comorbidity (possibly) because of surgical procedure
boolean
C0563273 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
Deterioration of comorbidity
Item
Deterioration of comorbidity:If `yes` please specify
text
C0563273 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
Other relevant complications
Item
Other relevant complications
boolean
C0009566 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Other relevant complications
Item
Other relevant complications:Please specify
text
C0009566 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Re-CEA
Item
Re-CEA/unplanned CEA
boolean
C0014099 (UMLS CUI [1,1])
C1527075 (UMLS CUI [1,2])
C1527075 (UMLS CUI [1,2])
Resuscitation
Item
Resuscitation
boolean
C0007203 (UMLS CUI [1])
Serious adverse events
Item
Did any serious adverse events occur?
boolean
C1519255 (UMLS CUI [1])
Artificial ventilation
Item
Patient is on artificial respiration longer than 30 days after surgery
boolean
C0035205 (UMLS CUI [1])
Concomitant Medication
Item
Does the patient take antiplatelet agents?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose from the list below, which antiplatelet drug the patient takes
integer
C0085826 (UMLS CUI [1])
Code List
Please choose from the list below, which antiplatelet drug the patient takes
CL Item
Acetyl salicylic acid (1)
CL Item
Clopidogrel (2)
CL Item
Acetyl salicylic acid plus Dipyridamole (3)
CL Item
More than one of the list (4)
CL Item
Other (5)
Antiplatelet drugs
Item
Please specify which antiplatelet drugs the patient took, if you chose `other`
text
C0085826 (UMLS CUI [1])
Concomitant Medication
Item
Does the patient take any anticoagulants?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose which one of the anticoagulants listed below the patient takes.
integer
C0003280 (UMLS CUI [1])
Code List
Please choose which one of the anticoagulants listed below the patient takes.
CL Item
Unfractionated heparin IV (1)
CL Item
Full dose LMW heparin (Enoxaparin , Others) (2)
CL Item
Vitamin K Antagonists like Warfarin (Coumadin) (3)
CL Item
Dabigatran (4)
CL Item
Other (5)
CL Item
More than one of the list (6)
Anticoagulants
Item
Please specify which anticoagulant the patient takes, if you chose `other`.
text
C0003280 (UMLS CUI [1])
Concomitant Medication
Item
Does the patient take any antihypertensive drugs?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose which one of the antihypertensive drugs listed below the patient takes.
integer
C0003364 (UMLS CUI [1])
Code List
Please choose which one of the antihypertensive drugs listed below the patient takes.
CL Item
ACE inhibitor (1)
CL Item
angiotensin receptor blocker (2)
CL Item
Diuretics (3)
CL Item
Calcium Antagonist (4)
CL Item
Beta blocker (5)
CL Item
Other (6)
CL Item
More than one of the list (7)
antihypertensive agent
Item
Please specify which antihypertensive agent the patient takes, if you chose `other`.
text
C0003364 (UMLS CUI [1])
Concomitant Medication
Item
Does the patient take any lipid lowering agents?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose which one of the antilipemic agents listed below the patient takes
integer
C0086440 (UMLS CUI [1])
Code List
Please choose which one of the antilipemic agents listed below the patient takes
CL Item
Statine (1)
CL Item
Other (2)
CL Item
More than one (3)
antilipemic agent
Item
Please specify which antilipemic agent the patient takes, if you chose `other`.
text
C0086440 (UMLS CUI [1])
Concomitant Medication
Item
Any other relevant concomitant medication the patient takes?
boolean
C2347852 (UMLS CUI [1])
Concomitant Medication
Item
Please specify what other concomitant medication the patient takes
text
C2347852 (UMLS CUI [1])
Other surgical procedures
Item
Has Subject undergone any other relevant surgical procedures other than recorded on this form
boolean
C0543467 (UMLS CUI [1])
Other surgical procedure
Item
Please specify the nature of the other surgical procedure
text
C0543467 (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])