ID

43768

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 (3)
  1. 3/7/16 3/7/16 -
  2. 3/7/16 3/7/16 -
  3. 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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Second year follow up Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

English

CABACS Case Report Form [second year follow up]

1 forms  
Screening: Outcome events
Description

Screening: Outcome events

Patient ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of interview
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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

If yes, please search for documentation of findings

Data type

boolean

Alias
UMLS CUI [1]
C0412675
Did the patient suffer a stroke or myocardial infarction since last visit?
Description

If yes, please fill in appropriate outcome event form

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027051
Modified Rankin Scale,structured interview
Description

Modified Rankin Scale,structured interview

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
Risk factors
Description

Risk factors

Smoking Status
Description

Tobacco Use

Data type

text

Alias
UMLS CUI [1]
C0543414
Body weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
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
Does the patient take any antidiabetic agents?
Description

Antidiabetics

Data type

integer

Alias
UMLS CUI [1]
C0935929
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 since last visit?
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
Interview answered by:
Description

Interview answered

Data type

integer

Alias
UMLS CUI [1,1]
C0021822
UMLS CUI [1,2]
C0508431
Date of completion of this form
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature by interviewer
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Name of interviewer
Description

Name of interviewer

Data type

text

Alias
UMLS CUI [1]
C0027365
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Similar models

CABACS Case Report Form [second year follow up]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Screening: Outcome events
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date
Item
Date of interview
date
C0011008 (UMLS CUI [1])
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])
Stroke or myocardial infarction
Item
Did the patient suffer a stroke or myocardial infarction since last visit?
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Item Group
Modified Rankin Scale,structured interview
Item
Do you (your family member) need constant nursing care?
text
C0204650 (UMLS CUI [1])
Constant nursing care
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])
Assistance ADL needed
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])
Home maintenance assistance
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])
Change in social life
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])
Neurologic Symptoms
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
Risk factors
Item
Smoking Status
text
C0543414 (UMLS CUI [1])
Tobacco Use
Code List
Smoking Status
CL Item
non-smoker (1)
CL Item
ex-smoker (2)
CL Item
current smoker (3)
Weight
Item
Body weight
float
C0005910 (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])
Antiplatelet drugs
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])
Anticoagulants
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])
Antihypertensive drugs
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)
CL Item
More than one of the list (7)
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])
Antilipemic agent
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])
Item
Does the patient take any antidiabetic agents?
integer
C0935929 (UMLS CUI [1])
Antidiabetics
Code List
Does the patient take any antidiabetic agents?
CL Item
No (0)
CL Item
oral antidiabetics (1)
CL Item
insulin (2)
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 since last visit?
boolean
C0543467 (UMLS CUI [1])
Other surgical procedure
Item
Please specify the nature of the other surgical procedure
text
C0543467 (UMLS CUI [1])
Item
Interview answered by:
integer
C0021822 (UMLS CUI [1,1])
C0508431 (UMLS CUI [1,2])
Interview answered
Code List
Interview answered by:
CL Item
Patient (1)
CL Item
Relative (2)
CL Item
residential care professional (3)
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by interviewer
text
C1519316 (UMLS CUI [1])
Name of interviewer
Item
Name of interviewer
text
C0027365 (UMLS CUI [1])
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