ID

43695

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

  1. 26.02.16 26.02.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Baseline visit Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

CABACS Case Report Form [Baseline visit]

Baseline Examination
Beschreibung

Baseline Examination

Date of visit
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Beschreibung

Patient Study ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
ECG done?
Beschreibung

ECG

Datentyp

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Beschreibung

Date

Datentyp

date

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

ECG findings

Datentyp

boolean

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

ECG findings

Datentyp

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.
Beschreibung

Outcome events

Datentyp

text

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

Concomitant Medication

Datentyp

boolean

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

Antiplatelet drugs

Datentyp

text

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

Antiplatelet drugs

Datentyp

text

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

Concomitant Medication

Datentyp

boolean

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

Anticoagulants

Datentyp

integer

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

Anticoagulants

Datentyp

text

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

Concomitant Medication

Datentyp

boolean

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

Antihypertensive drugs

Datentyp

text

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

antihypertensive agent

Datentyp

text

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

Concomitant Medication

Datentyp

boolean

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

Antilipemic agent

Datentyp

text

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

antilipemic agent

Datentyp

text

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

Concomitant Medication

Datentyp

boolean

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

Concomitant Medication

Datentyp

text

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

Date of completion

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beschreibung

Name of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C0008961

Ähnliche Modelle

CABACS Case Report Form [Baseline visit]

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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])
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])
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])
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])
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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