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ID
13801
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 (2)
- 07-03-16 07-03-16 -
- 20-09-21 20-09-21 -
Geüploaded op
7 maart 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Third year follow up Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521
CABACS Case Report Form [third year follow up]
- StudyEvent: ODM
Similar models
CABACS Case Report Form [third year follow up]
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date
Item
Date of interview
date
C0011008 (UMLS CUI [1])
Visual impairment
Item
Did the patient experience any (transient) visual impairment (since last visit)?
boolean
C3665347 (UMLS CUI [1])
Paresthesia or hemiplegia
Item
Did the patient experience paresthesia or weakness on one side of the body (since last visit)?
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 last visit)?
boolean
C0037822 (UMLS CUI [1])
New signs or symptoms
Item
Did the patient experience any new signs or symptoms (since last visit)?
boolean
C0037088 (UMLS CUI [1])
Cerebral imaging
Item
If at least one of the above has been answered `yes`, has cerebral imaging been performed?
boolean
C0412675 (UMLS CUI [1])
Stroke or myocardial infarction
Item
Did the patient suffer a stroke or myocardial infarction since last visit?
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0027051 (UMLS CUI [2])
Item
Do you (your family member) need constant nursing care?
text
C0204650 (UMLS CUI [1])
CL Item
yes (severe disability,bedridden,incontinence,constant nursing care in almost every aspect of daily life) (1)
CL Item
No (2)
Item
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
text
C2599638 (UMLS CUI [1])
Code List
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
CL Item
Yes (moderately severe disability, walking without help impossible,assistance with ADL´s needed) (1)
CL Item
No (2)
Item
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
text
C0150250 (UMLS CUI [1])
Code List
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
CL Item
Yes (Moderate disability, assistance needed but can walk with or without walking aid) (1)
CL Item
No (2)
Item
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
text
C0815198 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,2])
Code List
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
CL Item
Yes (mild disability, not all former activities can be performed but independend life without help is still possible) (1)
CL Item
No (2)
Item
Do you (your family member) have problems with reading or writing or to find the right words durin conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
text
C0235031 (UMLS CUI [1,1])
C0497297 (UMLS CUI [1,2])
C0497297 (UMLS CUI [1,2])
Code List
Do you (your family member) have problems with reading or writing or to find the right words durin conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
CL Item
Yes (no significant disability, despite symptoms all daily activities can be performed independently) (1)
CL Item
No (2)
Disability
Item
No disability at all
boolean
C0231170 (UMLS CUI [1])
CL Item
non-smoker (1)
CL Item
ex-smoker (2)
CL Item
current smoker (3)
Weight
Item
Body weight
float
C0005910 (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
Other (4)
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
Full dose LMW heparin (Enoxaparin , Others) (1)
CL Item
Vitamin K Antagonists like Warfarin (Coumadin) (2)
CL Item
Dabigatran (3)
CL Item
Other (4)
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
C0003367 (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)
Antilipemic agent
Item
Please specify which antilipemic agent the patient takes, if you chose `other`.
text
C0003367 (UMLS CUI [1])
CL Item
No (0)
CL Item
oral antidiabetics (1)
CL Item
insulin (2)
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 the patient undergone any other relevant surgical procedures other than recorded on this form since last visit?
boolean
C0543467 (UMLS CUI [1])
Other surgical procedure
Item
Please specify the nature of the other surgical procedure
text
C0543467 (UMLS CUI [1])
Item
Interview answered by:
integer
C0021822 (UMLS CUI [1,1])
C0508431 (UMLS CUI [1,2])
C0508431 (UMLS CUI [1,2])
CL Item
Patient (1)
CL Item
Relative (2)
CL Item
residential care professional (3)
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by interviewer
text
C1519316 (UMLS CUI [1])
Name of interviewer
Item
Name of interviewer
text
C0027365 (UMLS CUI [1])