ISRCTN13486906终止未知
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
niversity Hospital Essen (Universitatsklinikum Essen) (Germany)0 个研究点目标入组 127 人开始时间: 2010年10月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 127
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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