ID

13668

Beskrivning

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

Nyckelord

  1. 2016-02-25 2016-02-25 -
Uppladdad den

25 februari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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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]

Modified Rankin Scale,structured interview
Beskrivning

Modified Rankin Scale,structured interview

Date of screening for trial
Beskrivning

Date of screening

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
Patient ID
Beskrivning

Patient Study ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Do you (your family member) need constant nursing care?
Beskrivning

Constant nursing care

Datatyp

text

Alias
UMLS CUI [1]
C0204650
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
Beskrivning

Assistance ADL needed

Datatyp

text

Alias
UMLS CUI [1]
C2599638
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?
Beskrivning

Home maintenance assistance

Datatyp

text

Alias
UMLS CUI [1]
C0150250
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?
Beskrivning

Change in social life

Datatyp

text

Alias
UMLS CUI [1,1]
C0815198
UMLS CUI [1,2]
C0392747
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?
Beskrivning

Neurologic Symptoms

Datatyp

text

Alias
UMLS CUI [1,1]
C0235031
UMLS CUI [1,2]
C0497297
No disability at all
Beskrivning

Disability

Datatyp

boolean

Alias
UMLS CUI [1]
C0231170
Patient age
Beskrivning

Age

Datatyp

integer

Måttenheter
  • years
Alias
UMLS CUI [1]
C0001779
years
Did you perform the DemTect test with the patient?
Beskrivning

Psychometric testing for dementia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Count of correctly repeated words of wordlist: plate,dog,lamp,letter,apple,pants,table,lawn,glass,tree.
Beskrivning

See instruction for DemTect testing and converting table in your investigator file Please read the list to the patient, let him/her repeat and count correctly repeated words. Then read it to the patient a second time and let him/her repeat again. Add the count of correctly repeated to the first count

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Converting numbers: Count of correctly converted numbers 209= ;4054= ; sixhundredeightyone= ; twothousandeightyseven=
Beskrivning

I.e 5=five or three=3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please count the number of items to buy in a grocery store your patient can think of within one minute
Beskrivning

Psychometric testing for dementia

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please note the longest line of numbers (max. 6 numbers in a row) your patient was able to repeat backwards. Two attempts allowed.
Beskrivning

First attempt:7-2 ; 4-7-9; 5-4-9-6; 2-7-5-3-6; 8-1-3-5-4-2 Second attempt: 8-6; 3-1-5; 1-9-7-4; 1-3-5-4-8; 4-1-2-7-9-5

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please ask your patient to repeat again the ten words of the first question and count the correctly repeated words.
Beskrivning

Psychometric testing for dementia

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please note any particularities regarding the testing situation (i.e patient with hearing impairment, any interruption during testing...)
Beskrivning

Psychometric testing for dementia

Datatyp

text

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Date of completion of this form
Beskrivning

Date of completion

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator/neurologist
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator/neurologist
Beskrivning

Name of Investigator

Datatyp

text

Alias
UMLS CUI [1]
C0008961
Ultrasound examination
Beskrivning

Ultrasound examination

Date of ultrasound examination
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Percentage of stenosis (ECST) in right common carotid artery structure
Beskrivning

Doppler ultrasound right common carotid artery structure

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0226086
%
Intima media thickness of right common artery structure (1 cm proximal of bulb)
Beskrivning

Doppler ultrasound of right common artery structure

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0226086
mm
Percentage of stenosis of internal carotid artery structure (ECST)
Beskrivning

Doppler ultrasound of internal carotid artery structure

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0007276
%
Structure of right vertebral artery:
Beskrivning

Doppler ultrasound of structure of right vertebral artery

Datatyp

text

Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0226230
Structure of right supratrochlear artery
Beskrivning

Doppler ultrasound of structure of right supratrochlear artery

Datatyp

text

Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0226193
Echo pattern of the stenosis to be treated
Beskrivning

Doppler ultrasound of plaque morphology

Datatyp

text

Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0751633
UMLS CUI [1,3]
C0332437
Echogenicity of the stenosis to be treated
Beskrivning

Doppler ultrasound plaque morphology

Datatyp

text

Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0751633
UMLS CUI [1,3]
C0332437
Surface of the stenosis to be treated
Beskrivning

Doppler ultrasound plaque morphology

Datatyp

text

Alias
UMLS CUI [1,1]
C0162481
UMLS CUI [1,2]
C0751633
UMLS CUI [1,3]
C0332437
Method of measurement
Beskrivning

cerebrovascular reserve capacity on the side of stenosis to be treated

Datatyp

text

Alias
UMLS CUI [1,1]
C0225992
UMLS CUI [1,2]
C1516240
Measured acceleration of flow in middle cerebral artery
Beskrivning

Flow accelereation

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1,1]
C0000894
UMLS CUI [1,2]
C0232338
%
Deceleration of flow in middle cerebral artery
Beskrivning

Deceleration of flow

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011100
UMLS CUI [1,2]
C0232338
Doppler ultrasound of basilar artery
Beskrivning

Doppler ultrasound of basilar artery

Datatyp

text

Alias
UMLS CUI [1,1]
C0004811
UMLS CUI [1,2]
C0162481
Date of completion of this form
Beskrivning

Date of completion

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator/neurologist
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beskrivning

Name of Investigator

Datatyp

text

Alias
UMLS CUI [1]
C0008961

Similar models

CABACS Case Report Form [Modified Rankin scale,structured interview and ultrasound examination]

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Modified Rankin Scale,structured interview
Date of screening
Item
Date of screening for trial
date
C0011008 (UMLS CUI [1,1])
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])
Code List
Do you (your family member) need constant nursing care?
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Item Group
Ultrasound examination
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])
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])
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])
Item
Structure of right vertebral artery:
text
C0162481 (UMLS CUI [1,1])
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])
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])
Code List
Echo pattern of the stenosis to be treated
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])
Code List
Echogenicity of the stenosis to be treated
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])
Code List
Surface of the stenosis to be treated
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])
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])
Deceleration of flow
Item
Deceleration of flow in middle cerebral artery
boolean
C0011100 (UMLS CUI [1,1])
C0232338 (UMLS CUI [1,2])
Item
Doppler ultrasound of basilar artery
text
C0004811 (UMLS CUI [1,1])
C0162481 (UMLS CUI [1,2])
Code List
Doppler ultrasound of basilar artery
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])

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