Coronary Artery Bypass graft surgery in patients with asymptomatic carotid stenosis
- Conditions
- Coronary heart disease, carotid artery stenosisCirculatory SystemCoronary heart disease
- Registration Number
- ISRCTN13486906
- Lead Sponsor
- niversity Hospital Essen (Universitatsklinikum Essen) (Germany)
- Brief Summary
2012 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/22103798 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36082667/ 5-year results (added 12/09/2022) 2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28916664/ (added 26/10/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 127
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method <br> 1. Number of ischemic strokes ipsilateral to the initially higher grade, not occluded stenotic carotid artery within 30 days and 1 year<br> 2. Any stroke or vascular death within 30 days, 1 year and 5 years<br> 3. Deaths from any cause within 30 days, 1 year and 5 years<br> 4. Number of disabling strokes (definition: stroke with resulting impairment >3 on the modified Rankin Scale) within 30 days and 1 year<br> 5. Change of cognitive performance on the Demtec scale from randomization to 30 days and 1 year<br> 6. Technical failure of intervention<br> 7. Number of myocardial infarctions within 30 days, and from 30 days to 1 year<br> 8. Duration of ventilatory support after operation (CABG ± CEA)<br> 9. Total length of hospital stay and German diagnosis related group (G-DRG) for acute hospital stay<br> 10. Total length of ICU stay<br>