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ID
43733
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 (2)
- 03.03.16 03.03.16 -
- 20.09.21 20.09.21 -
Hochgeladen am
20. September 2021
DOI
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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]
- StudyEvent: ODM
Ähnliche Modelle
CABACS Case Report Form [1 year follow up]
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
C0162481 (UMLS CUI [1,2])
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])
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])
C0162481 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
stenosis signal (2)
CL Item
deceleration of flow (3)
CL Item
reversal of flow (4)
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])
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])
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])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Consciousness
text
C1697238 (UMLS CUI [1,1])
C0517960 (UMLS CUI [1,2])
C0517960 (UMLS CUI [1,2])
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])
C2237121 (UMLS CUI [1,2])
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])
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])
C0015413 (UMLS CUI [1,2])
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])
C0234628 (UMLS CUI [1,2])
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])
C0015457 (UMLS CUI [1,2])
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])
C0234130 (UMLS CUI [1,2])
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])
C0234130 (UMLS CUI [1,2])
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)
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])
C0439823 (UMLS CUI [1,2])
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])
C0150820 (UMLS CUI [1,2])
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)
CL Item
normal (1)
CL Item
slurred speech, but still understandable (2)
CL Item
mute or unintelligible/ anarthria (3)
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])
C0521654 (UMLS CUI [1,2])
Other neurologic deficits
Item
Please specify other neurologic deficits
text
C0521654 (UMLS CUI [1])
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])
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) (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])
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])
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
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 visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
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])
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])
C2718058 (UMLS CUI [1,2])
Item
Reason for early termination
text
C1522508 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,2])
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])
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])