Coronary Artery Bypass graft surgery in patients with asymptomatic carotid stenosis
| ISRCTN | ISRCTN13486906 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13486906 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/09/2010
- Registration date
- 25/10/2010
- Last edited
- 26/10/2022
- Recruitment status
- Stopped
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Scientific
Department of Neurology
University Hospital Essen
Hufelandstr. 55
Essen
45122
Germany
| Phone | +49 (0)201 723 6503 |
|---|---|
| christian.weimar@uk-essen.de |
Study information
| Study design | Randomised controlled open multicentre blinded parallel-group sequential trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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(s) | Institutional Review Board (IRB) of the Medical Faculty of Essen, 05/08/2010, ref: 10-4325 |
| 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 |
| Primary outcome measure | 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 study start date | 15/09/2010 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 316 |
| Total final enrolment | 127 |
| 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 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
Study participating centre
45122
Germany
Sponsor information
Hospital/treatment centre
Hufelandstr. 55
Essen
45122
Germany
| Website | http://www.uk-essen.de |
|---|---|
"ROR" |
https://ror.org/02na8dn90 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2012 | Yes | No | |
| Results article | 5-year results | 09/09/2022 | 12/09/2022 | Yes | No |
| Results article | 15/09/2017 | 26/10/2022 | Yes | No |
Editorial Notes
26/10/2022: Publication reference added.
12/09/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
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.
