ID

13738

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

Versions (1)
  1. 3/1/16 3/1/16 -
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March 1, 2016

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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

English

CABACS Case Report Form [Day 30 post-Op NIH Stroke scale]

1 forms  
NIH Stroke scale
Description

NIH Stroke scale

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
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
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
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Similar models

CABACS Case Report Form [Day 30 post-Op NIH Stroke scale]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
NIH Stroke scale
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Consciousness
text
C1697238 (UMLS CUI [1,1])
C0517960 (UMLS CUI [1,2])
NIH-Stroke Scale Consciousness
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])
NIH-Stroke Scale Orientation
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])
NIH-Stroke Scale
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])
NIH-Stroke Scale Eye movement
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])
NIH-Stroke Scale Peripheral vision
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])
NIH-Stroke Scale Facial expression
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])
NIH-Stroke Scale Motor function of arms
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])
NIH-Stroke Scale Motor function of legs
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])
NIH-Stroke Scale Ataxia
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])
NIH-Stroke Scale Sensibility
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])
NIH-Stroke Scale Verbal expression
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])
NIH-Stroke Scale Speech
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])
NIH stroke scale Neglect
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])
Modified Rankin Scale
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
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
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