ID

13702

Descripción

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

Palabras clave

  1. 29/2/16 29/2/16 -
Subido en

29 de febrero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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

CABACS Case Report Form [surgery documentation]

Surgery documentation
Descripción

Surgery documentation

Patient ID
Descripción

Patient Study ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date of hospital admission
Descripción

Date of hospital admission

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0184666
Pseudonymized copy enclosed?
Descripción

pseudonymized copy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3858753
Medical history and findings
Descripción

Please fill in the form below only if a pseudonymized copy is not available of if surgery was cancelled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
Clinical severity of heart failure (NYHA-Classification)
Descripción

NYHA Classification

Tipo de datos

text

Alias
UMLS CUI [1]
C1275491
Angina pectoris
Descripción

Angina pectoris

Tipo de datos

text

Alias
UMLS CUI [1]
C0002962
Myocardial infarction
Descripción

Myocardial infarction

Tipo de datos

text

Alias
UMLS CUI [1]
C0027051
Cardiogenic shock
Descripción

Cardiogenic shock

Tipo de datos

text

Alias
UMLS CUI [1]
C0036980
Resuscitation
Descripción

Resuscitation

Tipo de datos

text

Alias
UMLS CUI [1]
C0007203
Patient is on artificial respiration
Descripción

Artificial ventilation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035205
Pulmonary Hypertension
Descripción

Pulmonary Hypertension

Tipo de datos

integer

Alias
UMLS CUI [1]
C0020542
Cardiac rhythm
Descripción

Cardiac rhythm

Tipo de datos

integer

Alias
UMLS CUI [1]
C0232187
Patient wears an artificial cardiac pacemaker/defibrillator
Descripción

Pacemaker

Tipo de datos

text

Alias
UMLS CUI [1]
C0030163
ASA Classification
Descripción

ASA

Tipo de datos

integer

Alias
UMLS CUI [1]
C1531480
LVEF
Descripción

LVEF

Tipo de datos

integer

Alias
UMLS CUI [1]
C0428772
coronary angiography findings
Descripción

coronary angiography findings

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C0243095
Significant left main stem disease?
Descripción

left main stem disease

Tipo de datos

text

Alias
UMLS CUI [1]
C0856739
Previous percutaneous coronary intervention?
Descripción

Previous PCI

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1532338
Previous heart surgery or aortic surgery
Descripción

Previous heart surgery

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0205156
Other current infection
Descripción

Other current infection

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0521116
Diabetes mellitus
Descripción

Diabetes mellitus

Tipo de datos

integer

Alias
UMLS CUI [1]
C0011849
Arterial vascular disease
Descripción

Arterial vascular disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0497252
peripheral arterial disease
Descripción

peripheral arterial disease

Tipo de datos

text

Alias
UMLS CUI [1]
C1704436
Carotid artery disease
Descripción

Carotid artery disease

Tipo de datos

text

Alias
UMLS CUI [1]
C0007273
Aortic aneurysm
Descripción

Aortic aneurysm

Tipo de datos

integer

Alias
UMLS CUI [1]
C0003486
Other arterial diseases
Descripción

Other arterial diseases

Tipo de datos

text

Alias
UMLS CUI [1]
C0852949
Lung diseases
Descripción

Lung Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0024115
Neurologic diseases
Descripción

Neurologic diseases

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027765
Modified Rankin Stroke Scale score if you answered the previous question with CNS-1
Descripción

Modified Rankin Scale

Tipo de datos

text

Alias
UMLS CUI [1]
C2984908
Preoperative dialysis
Descripción

Preoperative dialysis

Tipo de datos

text

Alias
UMLS CUI [1]
C0011946
Serum creatinine preoperative
Descripción

Creatinine, Serum

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Serum creatinine preoperative
Descripción

Serum creatinine

Tipo de datos

float

Unidades de medida
  • μmol/l
Alias
UMLS CUI [1]
C0201976
μmol/l
Date of completion of this form
Descripción

Date of completion

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Descripción

Name of Investigator

Tipo de datos

text

Alias
UMLS CUI [1]
C0008961

Similar models

CABACS Case Report Form [surgery documentation]

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Surgery documentation
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date of hospital admission
Item
Date of hospital admission
date
C0011008 (UMLS CUI [1,1])
C0184666 (UMLS CUI [1,2])
pseudonymized copy
Item
Pseudonymized copy enclosed?
boolean
C3858753 (UMLS CUI [1])
Medical history
Item
Medical history and findings
boolean
C0262926 (UMLS CUI [1])
Item
Clinical severity of heart failure (NYHA-Classification)
text
C1275491 (UMLS CUI [1])
Code List
Clinical severity of heart failure (NYHA-Classification)
CL Item
I Normal physical capacity, asymptomatic (1)
CL Item
II symptoms under physical exertion (2)
CL Item
III symptoms under mild physical exertion (3)
CL Item
IV symptoms at rest (4)
Item
Angina pectoris
text
C0002962 (UMLS CUI [1])
Code List
Angina pectoris
CL Item
I. Ordinary physical activity does not cause angina (1)
CL Item
II. Slight limitation of ordinary activity (2)
CL Item
III. Marked limitation of ordinary activity (3)
CL Item
IV. Inability to carry out any physical activity without discomfort - angina syndrome may be present at rest (4)
Item
Myocardial infarction
text
C0027051 (UMLS CUI [1])
Code List
Myocardial infarction
CL Item
No (0)
CL Item
Yes, within last 48 hours (1)
CL Item
Yes,within past 21 days (2)
CL Item
Yes, longer than 21 but no longer than 91 days ago (3)
CL Item
Yes, more than 91 days ago (4)
CL Item
Yes but date of event unknown  (8)
CL Item
unknown (9)
Item
Cardiogenic shock
text
C0036980 (UMLS CUI [1])
Code List
Cardiogenic shock
CL Item
No (0)
CL Item
Yes, within last 48 hours (1)
CL Item
Yes, within past 21 days (2)
CL Item
Yes, longer than 21 days ago (3)
CL Item
Yes, but date of event unknown (8)
CL Item
unknown (9)
Item
Resuscitation
text
C0007203 (UMLS CUI [1])
Code List
Resuscitation
CL Item
No (0)
CL Item
Yes, within last 48 hours (1)
CL Item
Yes, within past 21 days (2)
CL Item
Yes, longer than 21 days ago (3)
CL Item
Yes, date of event unknown (8)
CL Item
unknown (9)
Artificial ventilation
Item
Patient is on artificial respiration
boolean
C0035205 (UMLS CUI [1])
Item
Pulmonary Hypertension
integer
C0020542 (UMLS CUI [1])
Code List
Pulmonary Hypertension
CL Item
Yes (1)
CL Item
No (2)
CL Item
unknown (9)
Item
Cardiac rhythm
integer
C0232187 (UMLS CUI [1])
Code List
Cardiac rhythm
CL Item
Normal sinus rhythm (1)
CL Item
Atrial fibrillation (2)
CL Item
Other (8)
Item
Patient wears an artificial cardiac pacemaker/defibrillator
text
C0030163 (UMLS CUI [1])
Code List
Patient wears an artificial cardiac pacemaker/defibrillator
CL Item
No (0)
CL Item
Yes,Pacemaker (1)
CL Item
Yes,Defibrillator (2)
Item
ASA Classification
integer
C1531480 (UMLS CUI [1])
Code List
ASA Classification
CL Item
A normal healthy patient (1)
CL Item
A patient with mild systemic disease (2)
CL Item
A patient with severe systemic disease (3)
CL Item
A patient with very severe systemic disease that is a constant threat to life (4)
CL Item
A moribund patient (5)
Item
LVEF
integer
C0428772 (UMLS CUI [1])
Code List
LVEF
CL Item
bad or less than 30% (1)
CL Item
average or 30-50% (2)
CL Item
good or more than 50% (3)
Item
coronary angiography findings
text
C0085532 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Code List
coronary angiography findings
CL Item
no coronary heart disease (0)
CL Item
1-vessel disease (1)
CL Item
2-vessel disease (2)
CL Item
3-vessel disease (3)
Item
Significant left main stem disease?
text
C0856739 (UMLS CUI [1])
Code List
Significant left main stem disease?
CL Item
No (0)
CL Item
Yes equal to or more than 50% (1)
CL Item
unknown (9)
Previous PCI
Item
Previous percutaneous coronary intervention?
boolean
C1532338 (UMLS CUI [1])
Item
Previous heart surgery or aortic surgery
integer
C0018821 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Code List
Previous heart surgery or aortic surgery
CL Item
number of interventions unknown, but at least one (8)
CL Item
unknown (9)
Item
Other current infection
text
C0009450 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Code List
Other current infection
CL Item
none (0)
CL Item
Mediastinitis (1)
CL Item
Bacteremia (2)
CL Item
broncho-pulmonary infection (3)
CL Item
oto-laryngologic infection (4)
CL Item
florid endocarditis (5)
CL Item
Peritonitis (6)
CL Item
thoracic wound infection (7)
CL Item
pleural empyema (8)
CL Item
infection of venous puncture site (9)
CL Item
UTI (10)
CL Item
wound infection of lower extremities (11)
CL Item
HIV infection (12)
CL Item
Hepatitis b or C (13)
CL Item
other wound infection (18)
CL Item
other general infection (88)
Item
Diabetes mellitus
integer
C0011849 (UMLS CUI [1])
Code List
Diabetes mellitus
CL Item
no (0)
CL Item
yes, only set dietary (1)
CL Item
yes, medical controlled (2)
CL Item
yes, insulin dependent (3)
CL Item
yes, untreated (4)
CL Item
unknown (9)
Item
Arterial vascular disease
integer
C0497252 (UMLS CUI [1])
Code List
Arterial vascular disease
CL Item
no (0)
CL Item
Yes (1)
CL Item
unknown (9)
Item
peripheral arterial disease
text
C1704436 (UMLS CUI [1])
Code List
peripheral arterial disease
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
Item
Carotid artery disease
text
C0007273 (UMLS CUI [1])
Code List
Carotid artery disease
CL Item
No (0)
CL Item
Yes (1)
CL Item
unknown (9)
Item
Aortic aneurysm
integer
C0003486 (UMLS CUI [1])
Code List
Aortic aneurysm
CL Item
no (0)
CL Item
Yes (1)
CL Item
unknown (9)
Item
Other arterial diseases
text
C0852949 (UMLS CUI [1])
Code List
Other arterial diseases
CL Item
No (0)
CL Item
Yes (1)
CL Item
unknown (9)
Item
Lung diseases
integer
C0024115 (UMLS CUI [1])
Code List
Lung diseases
CL Item
No (0)
CL Item
Yes COPD with chronic medication (1)
CL Item
Yes COPD without chronic medication (2)
CL Item
Yes, other lung disease (8)
CL Item
unknown (9)
Item
Neurologic diseases
integer
C0027765 (UMLS CUI [1])
Code List
Neurologic diseases
CL Item
No (0)
CL Item
Yes,CNS cerebrovascular (hemorrhage,ischemia) (1)
CL Item
Yes,CNS other (2)
CL Item
Yes, peripheral (3)
CL Item
Yes, combination (4)
CL Item
unknown (9)
Item
Modified Rankin Stroke Scale score if you answered the previous question with CNS-1
text
C2984908 (UMLS CUI [1])
Code List
Modified Rankin Stroke Scale score if you answered the previous question with CNS-1
CL Item
No symptoms at all (0)
CL Item
No significant disability despite symptoms; able to carry out all usual duties and activities (1)
CL Item
Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance (2)
CL Item
Moderate disability; requiring some help but able to walk without assistance (3)
CL Item
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance (4)
CL Item
Severe disability; bedridden, incontinent, and requiring constant nursing care and attention (5)
Item
Preoperative dialysis
text
C0011946 (UMLS CUI [1])
Code List
Preoperative dialysis
CL Item
No (0)
CL Item
Acute (1)
CL Item
Chronic (2)
Creatinine, Serum
Item
Serum creatinine preoperative
float
C0201976 (UMLS CUI [1])
Serum creatinine
Item
Serum creatinine preoperative
float
C0201976 (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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