ID

13736

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 (2)
  1. 3/1/16 3/1/16 -
  2. 3/1/16 3/1/16 -
Uploaded on

March 1, 2016

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License

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

English

CABACS Case Report Form [Day 7 post-Op]

1 forms  
Day 7 post surgery
Description

Day 7 post surgery

Date of visit
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Description

Patient Study ID

Data type

text

Alias
UMLS CUI [1]
C2348585
ECG
Description

ECG

Date ECG was performed
Description

ECG Date

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Any pathologic findings in ECG?
Description

ECG findings

Data type

boolean

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

ECG findings

Data type

text

Alias
UMLS CUI [1]
C0438154
Screening: Outcome events
Description

Screening: Outcome events

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

Paresthesia or hemiplegia

Data type

boolean

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

Speech disorder

Data type

boolean

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

New signs or symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0037088
Is at least one of the following adverse events present: cerebrovascular stroke, myocardial infaction,technical failure, death? If "yes" please fill in Adverse event form and send to study coordinator within 7 days.
Description

If you suspect cerebrovascular stroke, please initiate cerebral imaging

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Complications
Description

Complications

Deep wound infection
Description

Wound infection

Data type

boolean

Alias
UMLS CUI [1]
C0043241
Sepsis
Description

Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0243026
Deep vein thrombosis
Description

Venous thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0040053
Pulmonary Embolism
Description

Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0034065
Pneumonia
Description

Pneumonia

Data type

boolean

Alias
UMLS CUI [1]
C0032285
Injury of cervical nerves
Description

Injury of cervical nerves

Data type

boolean

Alias
UMLS CUI [1,1]
C1284720
UMLS CUI [1,2]
C0161479
Severe hemodynamic instability longer than 24h
Description

Hemodynamic instability

Data type

boolean

Alias
UMLS CUI [1]
C0948268
Carotid dilatation
Description

Carotid dilatation

Data type

boolean

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

Hemorrhage

Data type

boolean

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

Deterioration of comorbidity

Data type

boolean

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

Deterioration of comorbidity

Data type

text

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

Other relevant complications

Data type

boolean

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

Other relevant complications

Data type

text

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

Serious adverse events

Re-CEA/unplanned CEA
Description

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Date of completion of this form
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Description

Name of Investigator

Data type

text

Alias
UMLS CUI [1]
C0008961
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Similar models

CABACS Case Report Form [Day 7 post-Op]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Day 7 post surgery
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (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])
C0018991 (UMLS CUI [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,technical failure, 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])
Injury of cervical nerves
Item
Injury of cervical nerves
boolean
C1284720 (UMLS CUI [1,1])
C0161479 (UMLS CUI [1,2])
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])
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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