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Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis
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| ISRCTN | ISRCTN13486906 |
| ClinicalTrials.gov identifier | |
| Public title |
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis
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| 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 |
| Serial number at source | N/A |
| 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.
First patient in: 02/12/2010 |
| Lay summary | |
| Ethics approval | Institutional Review Board (IRB) of the Medical Faculty of Essen approved on the 5th August 2010 (ref: 10-4325) |
| Study design | Randomised controlled open multicentre blinded parallel group sequential trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Coronary heart disease, carotid artery stenosis |
| Participants - 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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 15/09/2010 |
| Anticipated end date | 31/12/2018 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 1160 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Christian Weimar |
| Address |
Department of Neurology
University Hospital Essen Hufelandstr. 55 |
| City/town | Essen |
| Zip/Postcode | 45122 |
| Country | Germany |
| Tel | +49 (0)201 723 2495 |
| christian.weimar@uk-essen.de | |
| Sponsor | University Hospital Essen (Universitatsklinikum Essen) (Germany) |
| Address | Hufelandstr. 55 |
| City/town | Essen |
| Zip/Postcode | 45122 |
| Country | Germany |
| Sponsor website: | http://www.uk-essen.de |
| Date applied | 07/09/2010 |
| Last edited | 15/03/2011 |
| Date ISRCTN assigned | 25/10/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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