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ID
13793
Beschreibung
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
Stichworte
Versionen (1)
- 07.03.16 07.03.16 -
Hochgeladen am
7. März 2016
DOI
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Creative Commons BY-NC 3.0
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Outcome event stroke Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521
CABACS Case Report Form [Outcome event stroke]
- StudyEvent: ODM
Ähnliche Modelle
CABACS Case Report Form [Outcome event stroke]
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date
Item
Date of stroke
date
C0011008 (UMLS CUI [1])
CL Item
right (1)
CL Item
left (2)
CL Item
indefinite (3)
Item
Duration of symptoms (until complete remission)
integer
C0436359 (UMLS CUI [1])
CL Item
<24 hrs (1)
CL Item
≥24 hrs (2)
CL Item
Persistent (3)
Item
Region of cerebrovascular accident
text
C0038454 (UMLS CUI [1,1])
C0007770 (UMLS CUI [1,2])
C0007770 (UMLS CUI [1,2])
CL Item
anterior cerebral artery (1)
CL Item
middle cerebral artery (2)
CL Item
posterior cerebral artery (3)
CL Item
vertebrobasilar (4)
Infarction at supply area of trial relevant carotid stenosis
Item
Infarction at supply area of trial relevant carotid stenosis
boolean
C0021308 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0007282 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C0007282 (UMLS CUI [1,3])
Item
Type of cerebrovascular infarction
text
C0332307 (UMLS CUI [1,1])
C1262200 (UMLS CUI [1,2])
C1262200 (UMLS CUI [1,2])
CL Item
ischemic (1)
CL Item
hemorrhagic (2)
CL Item
unknown (3)
CL Item
definite (1)
CL Item
probable (2)
CL Item
possible (3)
CL Item
not likely (4)
CL Item
no correlation (5)
CL Item
can not be assessed (6)
Item
Additional medical examination
integer
C0582103 (UMLS CUI [1,1])
C0940824 (UMLS CUI [1,2])
C0940824 (UMLS CUI [1,2])
CL Item
none (0)
CL Item
CCT (1)
CL Item
angiography (2)
CL Item
cerebral MRI (3)
CL Item
Doppler Ultrasonography (4)
Verification in diagnostic imaging
Item
Verification in diagnostic imaging
boolean
C1711411 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,2])
Description
Item
Please give a detailed description of the event
text
C0678257 (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])
Outcome assessment
Item
Date of stroke
date
C0085565 (UMLS CUI [1])
Outcome assessment
Item
Date of follow-up contact
date
C0085565 (UMLS CUI [1])
Item
Type of Contact (Select how the information was obtained:)
text
C0332307 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
CL Item
personal (1)
CL Item
phone contact (2)
CL Item
through another person (i.e health care provider,relative,...) (3)
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
Death (6)
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])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
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) 5 (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])