ID

43695

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

Versioner (2)
  1. 2016-02-26 2016-02-26 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Baseline visit Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

Engelsk

CABACS Case Report Form [Baseline visit]

1 Formulär  
Baseline Examination
Beskrivning

Baseline Examination

Date of visit
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Beskrivning

Patient Study ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
ECG done?
Beskrivning

ECG

Datatyp

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Any pathologic findings in ECG?
Beskrivning

ECG findings

Datatyp

boolean

Alias
UMLS CUI [1]
C0438154
Please specify any pathologic ECG findings
Beskrivning

ECG findings

Datatyp

text

Alias
UMLS CUI [1]
C0438154
Did any of the events listed below happen after randomization but before CABG surgery? If yes, please fill in the outcome event form.
Beskrivning

Outcome events

Datatyp

text

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0441471
Did the patient take antiplatelet agents the day before surgery?
Beskrivning

Concomitant Medication

Datatyp

boolean

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

Antiplatelet drugs

Datatyp

text

Alias
UMLS CUI [1]
C0085826
Please specify which antiplatelet drugs the patient took, if you chose "other" or "more than one"
Beskrivning

Antiplatelet drugs

Datatyp

text

Alias
UMLS CUI [1]
C0085826
Did the patient take any anticoagulants the day before surgery?
Beskrivning

Concomitant Medication

Datatyp

boolean

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

Anticoagulants

Datatyp

integer

Alias
UMLS CUI [1]
C0003280
Please specify which anticoagulant the patient took, if you chose "other" or "more than one".
Beskrivning

Anticoagulants

Datatyp

text

Alias
UMLS CUI [1]
C0003280
Did the patient take any antihypertensive drugs the day before surgery?
Beskrivning

Concomitant Medication

Datatyp

boolean

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

Antihypertensive drugs

Datatyp

text

Alias
UMLS CUI [1]
C0003364
Please specify which antihypertensive agent the patient took, if you chose "other" or "more than one".
Beskrivning

antihypertensive agent

Datatyp

text

Alias
UMLS CUI [1]
C0003364
Did the patient take any lipid lowering agents the day before surgery?
Beskrivning

Concomitant Medication

Datatyp

boolean

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

Antilipemic agent

Datatyp

text

Alias
UMLS CUI [1]
C0086440
Please specify which antilipemic agent the patient took, if you chose "other" or "more than one".
Beskrivning

antilipemic agent

Datatyp

text

Alias
UMLS CUI [1]
C0086440
Any other relevant concomitant medication the patient took the day before surgery?
Beskrivning

Concomitant Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Please specify what other concomitant medication the patient took
Beskrivning

Concomitant Medication

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Date of completion of this form
Beskrivning

Date of completion

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beskrivning

Name of Investigator

Datatyp

text

Alias
UMLS CUI [1]
C0008961
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Similar models

CABACS Case Report Form [Baseline visit]

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Baseline Examination
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
ECG
Item
ECG done?
boolean
C1623258 (UMLS CUI [1])
Date
Item
Date of ECG
date
C0011008 (UMLS CUI [1])
ECG findings
Item
Any pathologic findings in ECG?
boolean
C0438154 (UMLS CUI [1])
ECG findings
Item
Please specify any pathologic ECG findings
text
C0438154 (UMLS CUI [1])
Item
Did any of the events listed below happen after randomization but before CABG surgery? If yes, please fill in the outcome event form.
text
C1547647 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
Outcome events
Code List
Did any of the events listed below happen after randomization but before CABG surgery? If yes, please fill in the outcome event form.
CL Item
Stroke (1)
CL Item
Myocardial infarction (2)
CL Item
Death (3)
CL Item
Not applicable (4)
Concomitant Medication
Item
Did the patient take antiplatelet agents the day before surgery?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose from the list below, which antiplatelet drug the patient took
text
C0085826 (UMLS CUI [1])
Antiplatelet drugs
Code List
Please choose from the list below, which antiplatelet drug the patient took
CL Item
Acetyl salicylic acid (1)
CL Item
Clopidogrel (2)
CL Item
Acetyl salicylic acid plus Dipyridamole (3)
CL Item
More than one of the list (4)
CL Item
Other (5)
Antiplatelet drugs
Item
Please specify which antiplatelet drugs the patient took, if you chose "other" or "more than one"
text
C0085826 (UMLS CUI [1])
Concomitant Medication
Item
Did the patient take any anticoagulants the day before surgery?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose which one of the anticoagulants listed below the patient took.
integer
C0003280 (UMLS CUI [1])
Anticoagulant type
Code List
Please choose which one of the anticoagulants listed below the patient took.
CL Item
Unfractionated heparin IV (1)
CL Item
Full dose LMW heparin (Enoxaparin , Others) (2)
CL Item
Vitamin K Antagonists like Warfarin (Coumadin) (3)
CL Item
Dabigatran (4)
CL Item
Other (5)
CL Item
More than one of the list (6)
Anticoagulants
Item
Please specify which anticoagulant the patient took, if you chose "other" or "more than one".
text
C0003280 (UMLS CUI [1])
Concomitant Medication
Item
Did the patient take any antihypertensive drugs the day before surgery?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose which one of the antihypertensive drugs listed below the patient took.
text
C0003364 (UMLS CUI [1])
Antihypertensive drugs
Code List
Please choose which one of the antihypertensive drugs listed below the patient took.
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 took, if you chose "other" or "more than one".
text
C0003364 (UMLS CUI [1])
Concomitant Medication
Item
Did the patient take any lipid lowering agents the day before surgery?
boolean
C2347852 (UMLS CUI [1])
Item
Please choose which one of the antilipemic agents listed below the patient took
text
C0086440 (UMLS CUI [1])
Antilipemic agent
Code List
Please choose which one of the antilipemic agents listed below the patient took
CL Item
Statine (1)
CL Item
Other (2)
CL Item
More than one (3)
antilipemic agent
Item
Please specify which antilipemic agent the patient took, if you chose "other" or "more than one".
text
C0086440 (UMLS CUI [1])
Concomitant Medication
Item
Any other relevant concomitant medication the patient took the day before surgery?
boolean
C2347852 (UMLS CUI [1])
Concomitant Medication
Item
Please specify what other concomitant medication the patient took
text
C2347852 (UMLS CUI [1])
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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