ID

13631

Beschreibung

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis A randomized controlled clinical trial Kurztitel: CABACS DRKS Nummer DRKS00000521 IRSCTN Nummer 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 Telefon: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de Universitätsklinikum Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Telefon: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de Universitätsklinikum Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Stichworte

Versionen (1)
  1. 22/02/2016 22/02/2016 -
Hochgeladen am

22 février 2016

DOI

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Lizenz

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

Englisch

CABACS Case Report Form

1 Formulare  
Screening
Beschreibung

Screening

Study site number
Beschreibung

Study site number

Datentyp

integer

Alias
UMLS CUI [1]
C2825164
Patient ID
Beschreibung

Patient Study ID

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of screening for trial
Beschreibung

Date of screening

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
Inclusion criteria
Beschreibung

Inclusion criteria

Elective coronary artery bypass grafting planned
Beschreibung

Every question in this section must be truthfully answered "YES", if any of the questions has to be answered "NO", the patient cannot be included into this trial.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0206058
Extracranial carotid stenosis ≥80 percent (ECST),asymptomatic for at least 180 days
Beschreibung

Every question in this section must be truthfully answered "YES", if any of the questions has to be answered "NO", the patient cannot be included into this trial.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0580586
Eligible for carotid endarterectomy for treatment of carotid stenosis
Beschreibung

Every question in this section must be truthfully answered "YES", if any of the questions has to be answered "NO", the patient cannot be included into this trial.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0014099
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
18 Years and older
Beschreibung

Every question in this section must be truthfully answered "YES", if any of the questions has to be answered "NO", the patient cannot be included into this trial.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Patient is legally competent and has signed informed consent
Beschreibung

Every question in this section must be truthfully answered "YES", if any of the questions has to be answered "NO", the patient cannot be included into this trial.

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Patient is willing to come back for follow up
Beschreibung

Every question in this section must be truthfully answered "YES", if any of the questions has to be answered "NO", the patient cannot be included into this trial.

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Negative pregnancy test in females of childbearing potential.
Beschreibung

Every question in this section must be truthfully answered "YES", if any of the questions has to be answered "NO", the patient cannot be included into this trial.

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion criteria
Beschreibung

Exclusion criteria

Carotid stenosis other than atherosclerotic
Beschreibung

i.e Vascular wall dissection, floating thrombus, fibromuscular dysplasia, tumor All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0004153
UMLS CUI [1,3]
C0205394
Modified Rankin Scale score of >3 or severe aphasia
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1]
C3828944
UMLS CUI [2]
C0003537
Carotid artery occlusion
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1]
C0265101
Prior vascular stent in current stenosis
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1]
C0183521
Stenosis due to prior radiation therapy
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0279134
Ipsilateral carotid stenosis with higher grade inoperable stenosis (intracranial or intrathoracic)
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441989
UMLS CUI [1,2]
C0007282
Other known indication for carotid revascularization
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3495793
UMLS CUI [1,2]
C0205394
Myocardial infarction NSTEMI<48h or STEMI<7d or hemodynamic instability
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0948268
Intracranial hemorrhage within 90 days prior to enrollment
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1]
C0151699
Life expectancy less than one year due to comorbidities
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Simultaneously planned heart valve surgery or other cardiac surgery except CABG/CEA
Beschreibung

All questions must be answered with "NO", if one or more questions are answered "YES", the patient cannot be included.

Datentyp

boolean

Alias
UMLS CUI [1]
C0190065
UMLS CUI [2]
C0018821
Any other elective surgery planned during 8 weeks after randomization into this study
Beschreibung

elective surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0206058
Inclusion into any other clinical trial
Beschreibung

Study subject participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Date of completion of this form
Beschreibung

Date of completion

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Signature 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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Screening
Study site number
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
integer
C2348585 (UMLS CUI [1])
Date of screening
Item
Date of screening for trial
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Inclusion criteria
Elective coronary artery bypass grafting
Item
Elective coronary artery bypass grafting planned
boolean
C0010055 (UMLS CUI [1,1])
C0206058 (UMLS CUI [1,2])
Extracranial carotid stenosis
Item
Extracranial carotid stenosis ≥80 percent (ECST),asymptomatic for at least 180 days
boolean
C0007282 (UMLS CUI [1,1])
C0580586 (UMLS CUI [1,2])
Carotid endarterectomy for treatment of carotid stenosis
Item
Eligible for carotid endarterectomy for treatment of carotid stenosis
boolean
C0007282 (UMLS CUI [1,1])
C0014099 (UMLS CUI [1,2])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
Patient is legally competent and has signed informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
Patient is willing to come back for follow up
boolean
C1321605 (UMLS CUI [1])
Pregnancy test negative
Item
Negative pregnancy test in females of childbearing potential.
boolean
C0427780 (UMLS CUI [1])
Item Group
Exclusion criteria
Carotid stenosis other than atherosclerotic
Item
Carotid stenosis other than atherosclerotic
boolean
C0007282 (UMLS CUI [1,1])
C0004153 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Rankin Scale Score >3 or aphasia
Item
Modified Rankin Scale score of >3 or severe aphasia
boolean
C3828944 (UMLS CUI [1])
C0003537 (UMLS CUI [2])
Carotid artery occlusion
Item
Carotid artery occlusion
boolean
C0265101 (UMLS CUI [1])
Prior vascular stent
Item
Prior vascular stent in current stenosis
boolean
C0183521 (UMLS CUI [1])
Stenosis due to prior radiation therapy
Item
Stenosis due to prior radiation therapy
boolean
C0007282 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
Ipsilateral carotid stenosis
Item
Ipsilateral carotid stenosis with higher grade inoperable stenosis (intracranial or intrathoracic)
boolean
C0441989 (UMLS CUI [1,1])
C0007282 (UMLS CUI [1,2])
Other known indication for carotid revascularization
Item
Other known indication for carotid revascularization
boolean
C3495793 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Myocardial infarction or hemodynamic instability
Item
Myocardial infarction NSTEMI<48h or STEMI<7d or hemodynamic instability
boolean
C0027051 (UMLS CUI [1,1])
C0948268 (UMLS CUI [1,2])
Intracranial hemorrhage
Item
Intracranial hemorrhage within 90 days prior to enrollment
boolean
C0151699 (UMLS CUI [1])
Life expectancy
Item
Life expectancy less than one year due to comorbidities
boolean
C0023671 (UMLS CUI [1])
Heart valve surgery or other cardiac surgery
Item
Simultaneously planned heart valve surgery or other cardiac surgery except CABG/CEA
boolean
C0190065 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
elective surgery
Item
Any other elective surgery planned during 8 weeks after randomization into this study
boolean
C0206058 (UMLS CUI [1])
Study subject participation status
Item
Inclusion into any other clinical trial
boolean
C2348568 (UMLS CUI [1])
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature Investigator
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
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