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13668
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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- 25-02-16 25-02-16 -
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25 februari 2016
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Modified Rankin scale,structured interview and ultrasound examination Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521
CABACS Case Report Form [Modified Rankin scale,structured interview and ultrasound examination]
Similar models
CABACS Case Report Form [Modified Rankin scale,structured interview and ultrasound examination]
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Date of screening
Item
Date of screening for trial
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,2])
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) 4 (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) 3 (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) 2 (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 (1)
CL Item
No (2)
Disability
Item
No disability at all
boolean
C0231170 (UMLS CUI [1])
Age
Item
Patient age
integer
C0001779 (UMLS CUI [1])
Psychometric testing for dementia
Item
Did you perform the DemTect test with the patient?
boolean
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Count of correctly repeated words of wordlist: plate,dog,lamp,letter,apple,pants,table,lawn,glass,tree.
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Converting numbers: Count of correctly converted numbers 209= ;4054= ; sixhundredeightyone= ; twothousandeightyseven=
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please count the number of items to buy in a grocery store your patient can think of within one minute
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please note the longest line of numbers (max. 6 numbers in a row) your patient was able to repeat backwards. Two attempts allowed.
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please ask your patient to repeat again the ten words of the first question and count the correctly repeated words.
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please note any particularities regarding the testing situation (i.e patient with hearing impairment, any interruption during testing...)
text
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,2])
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by investigator/neurologist
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator/neurologist
text
C0008961 (UMLS CUI [1])
Date
Item
Date of ultrasound examination
date
C0011008 (UMLS CUI [1])
Doppler ultrasound right common carotid artery structure
Item
Percentage of stenosis (ECST) in right common carotid artery structure
float
C0162481 (UMLS CUI [1,1])
C0226086 (UMLS CUI [1,2])
C0226086 (UMLS CUI [1,2])
Doppler ultrasound of right common artery structure
Item
Intima media thickness of right common artery structure (1 cm proximal of bulb)
float
C0162481 (UMLS CUI [1,1])
C0226086 (UMLS CUI [1,2])
C0226086 (UMLS CUI [1,2])
Doppler ultrasound of internal carotid artery structure
Item
Percentage of stenosis of internal carotid artery structure (ECST)
integer
C0162481 (UMLS CUI [1,1])
C0007276 (UMLS CUI [1,2])
C0007276 (UMLS CUI [1,2])
Item
Structure of right vertebral artery:
text
C0162481 (UMLS CUI [1,1])
C0226230 (UMLS CUI [1,2])
C0226230 (UMLS CUI [1,2])
Code List
Structure of right vertebral artery:
CL Item
normal (1)
CL Item
hypoplasia (2)
CL Item
circulation disorder (3)
CL Item
occlusion (4)
Item
Structure of right supratrochlear artery
text
C0162481 (UMLS CUI [1,1])
C0226193 (UMLS CUI [1,2])
C0226193 (UMLS CUI [1,2])
Code List
Structure of right supratrochlear artery
CL Item
orthograde (1)
CL Item
retrograde (2)
Item
Echo pattern of the stenosis to be treated
text
C0162481 (UMLS CUI [1,1])
C0751633 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
C0751633 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
CL Item
homogeneous (1)
CL Item
inhomogeneous (2)
CL Item
inconclusive (3)
Item
Echogenicity of the stenosis to be treated
text
C0162481 (UMLS CUI [1,1])
C0751633 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
C0751633 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
CL Item
mostly hyperechoic (1)
CL Item
mostly hypoechoic (2)
CL Item
inconclusive (3)
Item
Surface of the stenosis to be treated
text
C0162481 (UMLS CUI [1,1])
C0751633 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
C0751633 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
CL Item
smooth (1)
CL Item
irregular (2)
CL Item
ulcerated (3)
CL Item
inconclusive (4)
Item
Method of measurement
text
C0225992 (UMLS CUI [1,1])
C1516240 (UMLS CUI [1,2])
C1516240 (UMLS CUI [1,2])
Code List
Method of measurement
CL Item
CO2-Breathing (5%) (1)
CL Item
Diamox (15mg/kgKG) (2)
CL Item
not assessed (3)
Flow accelereation
Item
Measured acceleration of flow in middle cerebral artery
float
C0000894 (UMLS CUI [1,1])
C0232338 (UMLS CUI [1,2])
C0232338 (UMLS CUI [1,2])
Deceleration of flow
Item
Deceleration of flow in middle cerebral artery
boolean
C0011100 (UMLS CUI [1,1])
C0232338 (UMLS CUI [1,2])
C0232338 (UMLS CUI [1,2])
Item
Doppler ultrasound of basilar artery
text
C0004811 (UMLS CUI [1,1])
C0162481 (UMLS CUI [1,2])
C0162481 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
stenosis signal (2)
CL Item
Deceleration (3)
CL Item
reversal of direction of flow (4)
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by investigator/neurologist
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])