Condition category
Circulatory System
Date applied
07/09/2010
Date assigned
25/10/2010
Last edited
24/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Stopped

Plain English Summary

Background and study aims
Coronary artery stenosis is a blockage of the arteries that supply blood to the heart muscle. It can be treated with a coronary artery bypass graft (CABG), which is a surgical procedure that diverts blood around the blocked part of the artery, or a carotid endarterectomy (CEA), which is a surgical procedure to unblock the artery. The aim of this study is to compare the safety and effectiveness of CABG alone versus CABG and CEA together in patients with coronary artery stenosis.

Who can participate?
Patients aged over 18 with coronary artery stenosis

What does the study involve?
Participants are randomly allocated to be treated with CABG either with or without CEA. The rates of non-fatal strokes or deaths are measured in both groups within 30 days after the surgery. Participants are followed-up for 1 year (including a physical and an ultrasound examination) with an additional yearly telephone follow-up for up to 5 years.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospital Essen (Germany)

When is the study starting and how long is it expected to run for?
September 2010 to December 2019

Who is funding the study?
Deutsche Forschungsgemeinschaft (Germany)

Who is the main contact?
Prof. Christian Weimar
christian.weimar@uk-essen.de

Trial website

http://www.cabacs.de

Contact information

Type

Scientific

Primary contact

Prof Christian Weimar

ORCID ID

Contact details

Department of Neurology
University Hospital Essen
Hufelandstr. 55
Essen
45122
Germany
+49 (0)201 723 6503
christian.weimar@uk-essen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis: a randomised controlled open multicentre group sequential trial with two parallel groups and blinded observers

Acronym

CABACS

Study hypothesis

The objective of this study is to compare the safety and efficacy of isolated coronary artery bypass graft (CABG) versus synchronous CABG and carotid endarterectomy (CEA) in patients with asymptomatic coronary artery stenosis (CAS) greater than or equal to 80% according to the European Carotid Surgery Trial (ECST) criteria.

Ethics approval

Institutional Review Board (IRB) of the Medical Faculty of Essen, 05/08/2010, ref: 10-4325

Study design

Randomised controlled open multicentre blinded parallel-group sequential trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary heart disease, carotid artery stenosis

Intervention

CABG with or without CEA must be performed as soon as possible (max. within 7 days) after randomisation. All patients will be treated with up-to-date medication following national and international guidelines. Recommendations for this treatment are provided by the 'Best Medical Treatment' subcommittee. Standards for surgical treatment have been formulated by the Surgical quality sub-committee. Aspirin (or clopidogrel) has to be applied before CABG as well as after surgery. All participating centres of cardiothoracic surgery are obligated to participate in a national quality management register. All participating surgeons have to meet the following standards:
1. Anonymous confirmation of the last 30 consecutively performed CEA, affirmed by the head of department
2. Anonymous confirmation of the last 150 consecutively performed CABG, affirmed by the head of department

Follow-up duration will be 1 year (including physical and ultrasound examination) with an additional yearly telephone follow-up up to 5 years after the intervention.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

The primary efficacy and safety endpoint is the event rate of nonfatal strokes or deaths from any cause (whatever occurs first) within 30 days after the intervention (either isolated CABG or synchronous CABG + CEA).

Secondary outcome measures

1. Number of ischemic strokes ipsilateral to the initially higher grade, not occluded stenotic carotid artery within 30 days and 1 year
2. Any stroke or vascular death within 30 days, 1 year and 5 years
3. Deaths from any cause within 30 days, 1 year and 5 years
4. Number of disabling strokes (definition: stroke with resulting impairment >3 on the modified Rankin Scale) within 30 days and 1 year
5. Change of cognitive performance on the Demtec scale from randomization to 30 days and 1 year
6. Technical failure of intervention
7. Number of myocardial infarctions within 30 days, and from 30 days to 1 year
8. Duration of ventilatory support after operation (CABG ± CEA)
9. Total length of hospital stay and German diagnosis related group (G-DRG) for acute hospital stay
10. Total length of ICU stay

Overall trial start date

15/09/2010

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects meeting all of the following criteria will be considered for admission to the trial:
1. Asymptomatic (past 180 days) stenosis greater than or equal to 80% (following criteria of the ECST of the extracranial carotid artery in patients scheduled for CABG)
2. Negative pregnancy test in pre-menopausal women
3. Written informed consent and full legal capacity
4. Carotid stenosis treatable with CEA
5. Ability of the patient to participate in follow-up examinations
6. Aged greater than or equal to 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

316

Participant exclusion criteria

Current exclusion criteria as of 09/04/2013:
Subjects presenting with any of the following criteria will not be included in the trial:
1. Non-atherosclerotic stenosis (e.g. dissection, floating thrombus, fibromuscular dysplasia, tumor)
2. Complete occlusion of the carotid artery to be treated
3. Prior stenting of the carotid artery to be treated
4. Stenosis following radiotherapy
5. Additional higher grade intracranial or intrathoracic stenosis (tandem stenosis)
6. Recent (past 180 days) ischemic symptoms ipsilateral to carotid stenosis or occlusion
7. Contralateral carotid occlusion or other known indication for carotid revascularization (apart from scheduled CABG)
8. NSTEMI within the past 48 hours, STEMI within the past 7 days or hemodynamically unstable patients
9. Evidence for intracranial bleeding within the past 90 days
10. Modified Rankin Scale score >3 or severe aphasia
11. Patients unlikely to survive more than 1 year due to concomitant diseases
12. Planned combined cardiac valve replacement or any other cardiac surgery beyond CABG (+/- CEA) during the procedure
13. Major surgery (apart from study procedures) planned within 8 weeks from randomization
14. Participation in another clinical trial

Previous exclusion criteria until 09/04/2013:
Subjects presenting with any of the following criteria will not be included in the trial:
1. Non-atherosclerotic stenosis (e.g. dissection, floating thrombus, fibromuscular dysplasia, tumor)
2. Complete occlusion of the carotid artery to be treated
3. Prior stenting of the carotid artery to be treated
4. Stenosis following radiotherapy
5. Additional higher grade intracranial or intrathoracic stenosis (tandem stenosis)
6. Recent (past 180 days) ischemic symptoms ipsilateral to carotid stenosis or occlusion
7. Contralateral carotid occlusion or other known indication for carotid revascularization (apart from scheduled CABG)
8. Myocardial infarction (NSTEMI or STEMI) within the past 7 days or hemodynamically unstable patients
9. Known high risk for cardiogenic embolism requiring anticoagulation (mechanical heart valve, chronic atrial fibrillation, left ventricular thrombus, left ventricular aneurysm)
10. Evidence for intracranial bleeding within the past 90 days
11. Modified Rankin Scale score >3 or severe aphasia
12. Patients unlikely to survive more than 1 year due to concomitant diseases
13. Planned combined cardiac valve replacement or any other cardiac surgery beyond CABG (+/- CEA) during the procedure
14. Major surgery (apart from study procedures) planned within 8 weeks from randomization
15. Participation in another clinical trial

Recruitment start date

01/12/2010

Recruitment end date

19/12/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Essen
Essen
45122
Germany

Sponsor information

Organisation

University Hospital Essen (Universitatsklinikum Essen) (Germany)

Sponsor details

Hufelandstr. 55
Essen
45122
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.uk-essen.de

Funders

Funder type

Research council

Funder name

Deutsche Forschungsgemeinschaft

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22103798

Publication citations

  1. Protocol

    Knipp SC, Scherag A, Beyersdorf F, Cremer J, Diener HC, Haverich JA, Jakob HG, Mohr W, Ose C, Reichenspurner H, Walterbusch G, Welz A, Weimar C, , Randomized comparison of synchronous CABG and carotid endarterectomy vs. isolated CABG in patients with asymptomatic carotid stenosis: the CABACS trial., Int J Stroke, 2012, 7, 4, 354-360, doi: 10.1111/j.1747-4949.2011.00687.x.

Additional files

Editorial Notes

24/06/2016: Plain English summary added. 20/10/2015: Recruitment ended on 19/12/2014 due to insufficient recruitment. The overall trial end date has been changed from 31/12/2018 to 31/12/2019. Additionally, the total number of participants has been changed from 1160 to 316.