ID

43730

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 (3)
  1. 01.03.16 01.03.16 -
  2. 02.03.16 02.03.16 -
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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

Englisch

CABACS Case Report Form [Day 30 post-Op]

1 Formulare  
Doppler Ultrasonography
Beschreibung

Doppler Ultrasonography

Right common carotid artery % stenosis according to ECST
Beschreibung

Common carotid artery stenosis

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0751635
%
Left common carotid artery % stenosis according to ECST
Beschreibung

Common carotid artery stenosis

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0751635
%
Right internal Carotid Artery % stenosis according to ECST
Beschreibung

Internal Carotid Artery Stenosis

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0340569
%
Left internal Carotid Artery % stenosis according to ECST
Beschreibung

Internal Carotid Artery Stenosis

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0340569
%
ECG
Beschreibung

ECG

Date ECG was performed
Beschreibung

ECG Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
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
Screening: Outcome events
Beschreibung

Screening: Outcome events

Did the patient experience any (transient) visual impairment (since surgery)?
Beschreibung

Visual impairment

Datentyp

boolean

Alias
UMLS CUI [1]
C3665347
Did the patient experience paresthesia or weakness on one side of the body (since surgery)?
Beschreibung

Paresthesia or hemiplegia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030554
UMLS CUI [1,2]
C0018991
Did the patient experience speech disorder (since surgery)?
Beschreibung

Speech disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0037822
Did the patient experience any new signs or symptoms (since surgery)?
Beschreibung

New signs or symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0037088
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.
Beschreibung

If you suspect cerebrovascular stroke, please initiate cerebral imaging

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Complications
Beschreibung

Complications

Deep wound infection
Beschreibung

Wound infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0043241
Sepsis
Beschreibung

Sepsis

Datentyp

boolean

Alias
UMLS CUI [1]
C0243026
Deep vein thrombosis
Beschreibung

Venous thrombosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0040053
Pulmonary Embolism
Beschreibung

Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0034065
Pneumonia
Beschreibung

Pneumonia

Datentyp

boolean

Alias
UMLS CUI [1]
C0032285
Severe hemodynamic instability longer than 24h
Beschreibung

Hemodynamic instability

Datentyp

boolean

Alias
UMLS CUI [1]
C0948268
Carotid dilatation
Beschreibung

Carotid dilatation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012359
UMLS CUI [1,2]
C0007272
Carotid bleeding requiring revision
Beschreibung

Hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0019080
Deterioration of comorbidity (possibly) because of surgical procedure
Beschreibung

Deterioration of comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0563273
UMLS CUI [1,2]
C0009488
Deterioration of comorbidity:If `yes` please specify
Beschreibung

Deterioration of comorbidity

Datentyp

text

Alias
UMLS CUI [1,1]
C0563273
UMLS CUI [1,2]
C0009488
Other relevant complications
Beschreibung

Other relevant complications

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205394
Other relevant complications:Please specify
Beschreibung

Other relevant complications

Datentyp

text

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205394
Serious adverse events
Beschreibung

Serious adverse events

Re-CEA/unplanned CEA
Beschreibung

Please fill in SAE form and send to study coordinator within 7 days via fax

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014099
UMLS CUI [1,2]
C1527075
Resuscitation
Beschreibung

Please fill in SAE form and send to study coordinator within 7 days via fax

Datentyp

boolean

Alias
UMLS CUI [1]
C0007203
Did any serious adverse events occur?
Beschreibung

Please fill in SAE form and send to study coordinator within 7 days via fax

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Patient is on artificial respiration longer than 30 days after surgery
Beschreibung

Artificial ventilation

Datentyp

boolean

Alias
UMLS CUI [1]
C0035205
Concomitant medication
Beschreibung

Concomitant medication

Does the patient take antiplatelet agents?
Beschreibung

Concomitant Medication

Datentyp

boolean

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

Antiplatelet drugs

Datentyp

integer

Alias
UMLS CUI [1]
C0085826
Please specify which antiplatelet drugs the patient took, if you chose `other`
Beschreibung

Antiplatelet drugs

Datentyp

text

Alias
UMLS CUI [1]
C0085826
Does the patient take any anticoagulants?
Beschreibung

Concomitant Medication

Datentyp

boolean

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

Anticoagulants

Datentyp

integer

Alias
UMLS CUI [1]
C0003280
Please specify which anticoagulant the patient takes, if you chose `other`.
Beschreibung

Anticoagulants

Datentyp

text

Alias
UMLS CUI [1]
C0003280
Does the patient take any antihypertensive drugs?
Beschreibung

Concomitant Medication

Datentyp

boolean

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

Antihypertensive drugs

Datentyp

integer

Alias
UMLS CUI [1]
C0003364
Please specify which antihypertensive agent the patient takes, if you chose `other`.
Beschreibung

antihypertensive agent

Datentyp

text

Alias
UMLS CUI [1]
C0003364
Does the patient take any lipid lowering agents?
Beschreibung

Concomitant Medication

Datentyp

boolean

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

Antilipemic agent

Datentyp

integer

Alias
UMLS CUI [1]
C0086440
Please specify which antilipemic agent the patient takes, if you chose `other`.
Beschreibung

antilipemic agent

Datentyp

text

Alias
UMLS CUI [1]
C0086440
Any other relevant concomitant medication the patient takes?
Beschreibung

Concomitant Medication

Datentyp

boolean

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

Concomitant Medication

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Has Subject undergone any other relevant surgical procedures other than recorded on this form
Beschreibung

Other surgical procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
Please specify the nature of the other surgical procedure
Beschreibung

Other surgical procedure

Datentyp

text

Alias
UMLS CUI [1]
C0543467
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
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Ähnliche Modelle

CABACS Case Report Form [Day 30 post-Op]

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Doppler Ultrasonography
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])
Internal Carotid Artery Stenosis
Item
Left internal Carotid Artery % stenosis according to ECST
integer
C0340569 (UMLS CUI [1])
Item Group
ECG
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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 Group
Screening: Outcome events
Visual impairment
Item
Did the patient experience any (transient) visual impairment (since surgery)?
boolean
C3665347 (UMLS CUI [1])
Paresthesia or hemiplegia
Item
Did the patient experience paresthesia or weakness on one side of the body (since surgery)?
boolean
C0030554 (UMLS CUI [1,1])
C0018991 (UMLS CUI [1,2])
Speech disorder
Item
Did the patient experience speech disorder (since surgery)?
boolean
C0037822 (UMLS CUI [1])
New signs or symptoms
Item
Did the patient experience any new signs or symptoms (since surgery)?
boolean
C0037088 (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])
Item Group
Complications
Wound infection
Item
Deep wound infection
boolean
C0043241 (UMLS CUI [1])
Sepsis
Item
Sepsis
boolean
C0243026 (UMLS CUI [1])
Venous thrombosis
Item
Deep vein thrombosis
boolean
C0040053 (UMLS CUI [1])
Pulmonary Embolism
Item
Pulmonary Embolism
boolean
C0034065 (UMLS CUI [1])
Pneumonia
Item
Pneumonia
boolean
C0032285 (UMLS CUI [1])
Hemodynamic instability
Item
Severe hemodynamic instability longer than 24h
boolean
C0948268 (UMLS CUI [1])
Carotid dilatation
Item
Carotid dilatation
boolean
C0012359 (UMLS CUI [1,1])
C0007272 (UMLS CUI [1,2])
Hemorrhage
Item
Carotid bleeding requiring revision
boolean
C0019080 (UMLS CUI [1])
Deterioration of comorbidity
Item
Deterioration of comorbidity (possibly) because of surgical procedure
boolean
C0563273 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Deterioration of comorbidity
Item
Deterioration of comorbidity:If `yes` please specify
text
C0563273 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Other relevant complications
Item
Other relevant complications
boolean
C0009566 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other relevant complications
Item
Other relevant complications:Please specify
text
C0009566 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Serious adverse events
Re-CEA
Item
Re-CEA/unplanned CEA
boolean
C0014099 (UMLS CUI [1,1])
C1527075 (UMLS CUI [1,2])
Resuscitation
Item
Resuscitation
boolean
C0007203 (UMLS CUI [1])
Serious adverse events
Item
Did any serious adverse events occur?
boolean
C1519255 (UMLS CUI [1])
Artificial ventilation
Item
Patient is on artificial respiration longer than 30 days after surgery
boolean
C0035205 (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
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`
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
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 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)
CL Item
More than one (3)
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 Subject 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])
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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