ID

43733

Description

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

Keywords

  1. 3/3/16 3/3/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

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 [1 year follow up]

Doppler Ultrasonography
Description

Doppler Ultrasonography

Right common carotid artery % stenosis according to ECST
Description

Common carotid artery stenosis

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0751635
%
Left common carotid artery % stenosis according to ECST
Description

Common carotid artery stenosis

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0751635
%
Right internal Carotid Artery % stenosis according to ECST
Description

Internal Carotid Artery Stenosis

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0340569
%
Left internal Carotid Artery % stenosis according to ECST
Description

Doppler ultrasonography of internal Carotid Artery Stenosis

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0340569
%
Doppler ultrasonography of right vertebral arteria
Description

Doppler ultrasonography of right vertebral arteria

Data type

text

Alias
UMLS CUI [1,1]
C0042559
UMLS CUI [1,2]
C0162481
Doppler ultrasonography of left vertebral artery
Description

Doppler ultrasonography of left vertebral artery

Data type

integer

Alias
UMLS CUI [1,1]
C0042559
UMLS CUI [1,2]
C0162481
Doppler Ultrasonography of basilar artery
Description

Doppler Ultrasonography of basilar artery

Data type

integer

Alias
UMLS CUI [1,1]
C0004811
UMLS CUI [1,2]
C0162481
Screening: Outcome events
Description

Screening: Outcome events

Did the patient experience any (transient) visual impairment (since last visit)?
Description

Visual impairment

Data type

boolean

Alias
UMLS CUI [1]
C3665347
Did the patient experience paresthesia or weakness on one side of the body (since last visit)?
Description

Paresthesia or hemiplegia

Data type

boolean

Alias
UMLS CUI [1,1]
C0030554
UMLS CUI [1,2]
C0018991
Did the patient experience speech disorder (since last visit)?
Description

Speech disorder

Data type

boolean

Alias
UMLS CUI [1]
C0037822
Did the patient experience any new signs or symptoms (since last visit)?
Description

New signs or symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0037088
If at least one of the above has been answered "yes", has cerebral imaging been performed?
Description

Cerebral imaging

Data type

boolean

Alias
UMLS CUI [1]
C0412675
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.
Description

Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant medication
Description

Concomitant medication

Does the patient take antiplatelet agents?
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please choose from the list below, which antiplatelet drug the patient takes
Description

Antiplatelet drugs

Data type

integer

Alias
UMLS CUI [1]
C0085826
Please specify which antiplatelet drugs the patient took, if you chose `other`
Description

Antiplatelet drugs

Data type

text

Alias
UMLS CUI [1]
C0085826
Does the patient take any anticoagulants?
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please choose which one of the anticoagulants listed below the patient takes.
Description

Anticoagulants

Data type

integer

Alias
UMLS CUI [1]
C0003280
Please specify which anticoagulant the patient takes, if you chose `other`.
Description

Anticoagulants

Data type

text

Alias
UMLS CUI [1]
C0003280
Does the patient take any antihypertensive drugs?
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please choose which one of the antihypertensive drugs listed below the patient takes.
Description

Antihypertensive drugs

Data type

integer

Alias
UMLS CUI [1]
C0003364
Please specify which antihypertensive agent the patient takes, if you chose `other`.
Description

antihypertensive agent

Data type

text

Alias
UMLS CUI [1]
C0003364
Does the patient take any lipid lowering agents?
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please choose which one of the antilipemic agents listed below the patient takes
Description

Antilipemic agent

Data type

integer

Alias
UMLS CUI [1]
C0086440
Please specify which antilipemic agent the patient takes, if you chose `other`.
Description

Antilipemic agent

Data type

text

Alias
UMLS CUI [1]
C0086440
Any other relevant concomitant medication the patient takes?
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please specify what other concomitant medication the patient takes
Description

Concomitant Medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Has the patient undergone any other relevant surgical procedures other than recorded on this form
Description

Other surgical procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
Please specify the nature of the other surgical procedure
Description

Other surgical procedure

Data type

text

Alias
UMLS CUI [1]
C0543467
NIH Stroke scale
Description

NIH Stroke scale

Patient ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Consciousness
Description

NIH-Stroke Scale Consciousness

Data type

text

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0517960
Orientation to age and month
Description

NIH-Stroke Scale Orientation

Data type

text

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C2237121
Request patient to close eyes and to squeeze hand
Description

NIH-Stroke Scale

Data type

text

Alias
UMLS CUI [1]
C1697238
Eye movement
Description

NIH-Stroke Scale Eye movement

Data type

integer

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0015413
Peripheral vision
Description

NIH-Stroke Scale Peripheral vision

Data type

integer

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0234628
Facial expression
Description

NIH-Stroke Scale Facial expression

Data type

text

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0015457
Motor function of arms ( one arm at a time)
Description

NIH-Stroke Scale Motor function of arms

Data type

text

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0234130
Motor function of legs (One leg at a time)
Description

NIH-Stroke Scale Motor function of legs

Data type

text

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0234130
Ataxia
Description

NIH-Stroke Scale Ataxia

Data type

integer

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0004134
Sensibility
Description

NIH-Stroke Scale Sensibility

Data type

integer

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0439823
Verbal expression
Description

NIH-Stroke Scale Verbal expression

Data type

integer

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0150820
Speech
Description

NIH-Stroke Scale Speech

Data type

text

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0846595
Neglect
Description

NIH stroke scale Neglect

Data type

text

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0150088
Other neurologic deficits
Description

NIH stroke scale Other neurologic deficits

Data type

boolean

Alias
UMLS CUI [1,1]
C1697238
UMLS CUI [1,2]
C0521654
Please specify other neurologic deficits
Description

Other neurologic deficits

Data type

text

Alias
UMLS CUI [1]
C0521654
Modified Rankin Stroke Scale score
Description

Modified Rankin Scale

Data type

text

Alias
UMLS CUI [1]
C2984908
Date of completion of this form
Description

Date of completion

Data type

date

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

Signature

Data type

text

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

Name of Investigator

Data type

text

Alias
UMLS CUI [1]
C0008961
Modified Rankin Scale,structured interview
Description

Modified Rankin Scale,structured interview

Patient ID
Description

Patient Study ID

Data type

text

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

Constant nursing care

Data type

text

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

Assistance ADL needed

Data type

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?
Description

Home maintenance assistance

Data type

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?
Description

Change in social life

Data type

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?
Description

Neurologic Symptoms

Data type

text

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

Disability

Data type

boolean

Alias
UMLS CUI [1]
C0231170
DemTect A
Description

DemTect A

Date of visit
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient age
Description

Age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Did you perform the DemTect test with the patient?
Description

Psychometric testing for dementia

Data type

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.
Description

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

Data type

integer

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

I.e 5=five or three=3

Data type

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
Description

Psychometric testing for dementia

Data type

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.
Description

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

Data type

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.
Description

Psychometric testing for dementia

Data type

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...)
Description

Psychometric testing for dementia

Data type

text

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

Date

Data type

date

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

Signature

Data type

text

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

Name of Investigator

Data type

text

Alias
UMLS CUI [1]
C0008961
Completion Form Hospital
Description

Completion Form Hospital

Date of visit
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Completion Status
Description

Completion Status

Data type

text

Alias
UMLS CUI [1]
C0805732
Consent and permission for follow-up phone contact once a year
Description

Consent and permission for contact

Data type

integer

Alias
UMLS CUI [1,1]
C0514044
UMLS CUI [1,2]
C0511422
Date early termination of clinical trial
Description

Date early termination of clinical trial

Data type

date

Alias
UMLS CUI [1,1]
C2983670
UMLS CUI [1,2]
C2718058
Reason for early termination
Description

Reason for early termination

Data type

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C2718058
Reason for early termination:please specify
Description

Reason for early termination

Data type

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C2718058
Date of completion of this form
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Description

Name of Investigator

Data type

text

Alias
UMLS CUI [1]
C0008961

Similar models

CABACS Case Report Form [1 year follow up]

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Doppler Ultrasonography
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])
Doppler ultrasonography of internal Carotid Artery Stenosis
Item
Left internal Carotid Artery % stenosis according to ECST
integer
C0340569 (UMLS CUI [1])
Item
Doppler ultrasonography of right vertebral arteria
text
C0042559 (UMLS CUI [1,1])
C0162481 (UMLS CUI [1,2])
Code List
Doppler ultrasonography of right vertebral arteria
CL Item
normal (1)
CL Item
Hypoplasia (2)
CL Item
circulatory disruption (3)
CL Item
occlusion (4)
Item
Doppler ultrasonography of left vertebral artery
integer
C0042559 (UMLS CUI [1,1])
C0162481 (UMLS CUI [1,2])
Code List
Doppler ultrasonography of left vertebral artery
CL Item
normal (1)
CL Item
Hypoplasia (2)
CL Item
circulatory disruption (3)
CL Item
occlusion (4)
Item
Doppler Ultrasonography of basilar artery
integer
C0004811 (UMLS CUI [1,1])
C0162481 (UMLS CUI [1,2])
Code List
Doppler Ultrasonography of basilar artery
CL Item
normal (1)
CL Item
stenosis signal (2)
CL Item
deceleration of flow (3)
CL Item
reversal of flow (4)
Item Group
Screening: Outcome events
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])
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])
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])
Item Group
Concomitant medication
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)
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)
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 the patient 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])
Item Group
NIH Stroke scale
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Consciousness
text
C1697238 (UMLS CUI [1,1])
C0517960 (UMLS CUI [1,2])
Code List
Consciousness
CL Item
awake  (1)
CL Item
dazed,reaction to small stimuli  (2)
CL Item
stuporous,reaction only to repeated or strong stimuli  (3)
CL Item
comatose (4)
Item
Orientation to age and month
text
C1697238 (UMLS CUI [1,1])
C2237121 (UMLS CUI [1,2])
Code List
Orientation to age and month
CL Item
both answers correct  (1)
CL Item
one answer correct  (2)
CL Item
no answer correct (3)
Item
Request patient to close eyes and to squeeze hand
text
C1697238 (UMLS CUI [1])
Code List
Request patient to close eyes and to squeeze hand
CL Item
followed both requests correctly  (1)
CL Item
followed one request correctly  (2)
CL Item
followed no request correctly (3)
Item
Eye movement
integer
C1697238 (UMLS CUI [1,1])
C0015413 (UMLS CUI [1,2])
Code List
Eye movement
CL Item
normal  (1)
CL Item
partial gaze palsy  (2)
CL Item
forced deviation (total gaze paresis) (3)
Item
Peripheral vision
integer
C1697238 (UMLS CUI [1,1])
C0234628 (UMLS CUI [1,2])
Code List
Peripheral vision
CL Item
normal  (1)
CL Item
partial visual field loss  (2)
CL Item
total hemianopsia  (3)
CL Item
bilateral hemianopsia or blindness (4)
Item
Facial expression
text
C1697238 (UMLS CUI [1,1])
C0015457 (UMLS CUI [1,2])
Code List
Facial expression
CL Item
normal  (1)
CL Item
little asymmetry  (2)
CL Item
partial paresis of lower half of the face  (3)
CL Item
total facial paresis (4)
Item
Motor function of arms ( one arm at a time)
text
C1697238 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
Code List
Motor function of arms ( one arm at a time)
CL Item
right: no dropping  (1)
CL Item
right: dropping of arm within 10 sec  (2)
CL Item
right:drops arm onto the pad,raise possible against gravity  (3)
CL Item
right:no active raise against gravity  (4)
CL Item
right:no movement at all  (5)
CL Item
right:amputation or joint immobility  (6)
CL Item
left: no dropping  (7)
CL Item
left: dropping of arm within 10 sec  (8)
CL Item
left:drops arm onto the pad,raise possible against gravity  (9)
CL Item
left:no active raise against gravity  (10)
CL Item
left:no movement at all  (11)
CL Item
left:amputation or joint immobility (12)
Item
Motor function of legs (One leg at a time)
text
C1697238 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
Code List
Motor function of legs (One leg at a time)
CL Item
right: no dropping  (1)
CL Item
right: dropping of leg within 10 sec  (2)
CL Item
right:drops leg onto the pad,raise possible against gravity  (3)
CL Item
right:no active raise against gravity  (4)
CL Item
right:no movement at all  (5)
CL Item
right:amputation or joint immobility  (6)
CL Item
left: no dropping  (7)
CL Item
left: dropping of leg within 10 sec  (8)
CL Item
left:drops leg onto the pad,raise possible against gravity  (9)
CL Item
left:no active raise against gravity  (10)
CL Item
left:no movement at all  (11)
CL Item
left:amputation or joint immobility (12)
Item
Ataxia
integer
C1697238 (UMLS CUI [1,1])
C0004134 (UMLS CUI [1,2])
Code List
Ataxia
CL Item
no ataxia or only related to paresis  (1)
CL Item
ataxia of one extremity  (2)
CL Item
ataxia of two or more extremities (3)
Item
Sensibility
integer
C1697238 (UMLS CUI [1,1])
C0439823 (UMLS CUI [1,2])
Code List
Sensibility
CL Item
normal  (1)
CL Item
partial loss of sensibility  (2)
CL Item
severe or total loss of sensibility (3)
Item
Verbal expression
integer
C1697238 (UMLS CUI [1,1])
C0150820 (UMLS CUI [1,2])
Code List
Verbal expression
CL Item
no aphasia  (1)
CL Item
reduced verbal fluency or reduced speech understanding  (2)
CL Item
severe aphasia or fragmented verbal expression  (3)
CL Item
global aphasia/Muteness (4)
Item
Speech
text
C1697238 (UMLS CUI [1,1])
C0846595 (UMLS CUI [1,2])
Code List
Speech
CL Item
normal  (1)
CL Item
slurred speech, but still understandable  (2)
CL Item
mute or unintelligible/ anarthria (3)
Item
Neglect
text
C1697238 (UMLS CUI [1,1])
C0150088 (UMLS CUI [1,2])
Code List
Neglect
CL Item
no neglect  (1)
CL Item
partial hemi-neglect of one quality  (2)
CL Item
severe hemi-neglect of more than one quality (3)
NIH stroke scale Other neurologic deficits
Item
Other neurologic deficits
boolean
C1697238 (UMLS CUI [1,1])
C0521654 (UMLS CUI [1,2])
Other neurologic deficits
Item
Please specify other neurologic deficits
text
C0521654 (UMLS CUI [1])
Item
Modified Rankin Stroke Scale score
text
C2984908 (UMLS CUI [1])
Code List
Modified Rankin Stroke Scale score
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/neurologist
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator/neurologist
text
C0008961 (UMLS CUI [1])
Item Group
Modified Rankin Scale,structured interview
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)  (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])
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])
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])
Item Group
DemTect A
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (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
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
Completion Form Hospital
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Completion Status
text
C0805732 (UMLS CUI [1])
Code List
Completion Status
CL Item
Appointment at year 1 was taken (1)
CL Item
premature end of study (2)
Item
Consent and permission for follow-up phone contact once a year
integer
C0514044 (UMLS CUI [1,1])
C0511422 (UMLS CUI [1,2])
Code List
Consent and permission for follow-up phone contact once a year
CL Item
permission for follow-up contact once a year (1)
CL Item
permission for follow up refused (2)
Date early termination of clinical trial
Item
Date early termination of clinical trial
date
C2983670 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
Item
Reason for early termination
text
C1522508 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
Code List
Reason for early termination
CL Item
informed consent withdrawn (1)
CL Item
patient safety at risk (at investigators discretion) (2)
CL Item
poor protocol compliance with impact on validity of trial data (specify) (3)
CL Item
Occurence of exclusion criteria before CABG +/- CEA (4)
CL Item
Occurence of endpoint events before CABG +/- CEA (specify) (5)
CL Item
Patient is unable to come for follow up visits (6)
CL Item
death (fill in outcome event form) (7)
CL Item
other reason (specify) (8)
Reason for early termination
Item
Reason for early termination:please specify
text
C1522508 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
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])

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