Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 380
- 试验地点
- 8
- 主要终点
- Incidence of new-onset postoperative silent brain infarction (SBI)
研究概览
简要总结
To explore surgical strategies that reduce perioperative neurologic complications in cardiovascular surgery, with the aim of improving perioperative outcomes and quality of life while reducing the socioeconomic burden. Specifically:
This multicenter, randomized controlled clinical trial will evaluate the benefits of a novel aortic no-touch technique in reducing perioperative silent brain infarction(SBI) among patients undergoing surgical treatment for coronary artery disease. The findings are expected to provide a safe and effective myocardial revascularization strategy for individuals at high risk of cerebral ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years old) with multivessel coronary artery disease who are scheduled to undergo isolated off-pump coronary artery bypass grafting and who provide informed consent to participate in this study.
排除标准
- •Indications for cardiopulmonary bypass surgery (or no contraindications to on-pump surgery);
- •Great saphenous vein is unsuitable for use as a graft conduit;
- •Subclavian artery stenosis or occlusion, or any contraindication to the use of the internal mammary artery as a graft conduit;
- •History of previous cardiac surgery;
- •Emergency surgery;
- •Inability to apply an aortic clamp due to severe ascending aortic calcification;
- •Expected inability to tolerate MRI or contraindications to MRI (e.g., known intolerance to MRI, an implanted permanent pacemaker, or an anticipated need for permanent pacemaker implantation);
- •Inability to complete neurocognitive assessment due to language barriers or visual/hearing impairment.
研究组 & 干预措施
Traditional off-pump coronary artery bypass grafting (Ao-SVG)
Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.
干预措施: Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG) (Procedure)
Aortic no-touch coronary artery bypass grafting (RIMA-SVG)
Aortic no-touch off-pump CABG in which the saphenous vein graft (SVG) is anastomosed to the right internal mammary artery (RIMA) as a composite graft, avoiding any clamping or manipulation of the ascending aorta.
干预措施: Aortic no-touch coronary artery bypass grafting (RIMA-SVG) (Procedure)
结局指标
主要结局
Incidence of new-onset postoperative silent brain infarction (SBI)
时间窗: Before postoperative discharge (approximately postoperative day 5)
Defined as newly developed cerebral infarctions identified on postoperative MRI, compared with the preoperative MRI, without any corresponding clinical signs or symptoms of cerebral infarction.
Saphenous vein graft (SVG) occlusion rate
时间窗: 1 year after surgery
Assessed by coronary computed tomography angiography (CCTA)
New-onset clinical stroke and silent brain infarction (SBI)
时间窗: 7 ± 3 days after surgery
Clinical stroke and SBI assessed at 7 ± 3 days postoperatively; SBI assessed by brain magnetic resonance imaging (MRI).
次要结局
- Incidence of postoperative delirium(within 5 postoperative days)
- Perioperative major adverse cardiovascular and cerebrovascular events (MACCE)(within 30 postoperative days)
- Incidence of postoperative delirium(within 5 postoperative days)
- Perioperative major adverse cardiovascular and cerebrovascular events (MACCE)(within 30 postoperative days)
- Six-month postoperative graft patency rate (assessed by coronary CT angiography)(6 months after surgery)
- MACCE within 6 months after surgery(6 months after surgery)
- Angina within 6 months after surgery(6 months after surgery)
- Incidence of perioperative neurocognitive disorder (PND)(within 7 days after surgery)
- MACCE within 3 months after surgery(Up to 3 months after surgery (3-month follow-up))
- Clinical stroke within 3 months after surgery(Up to 3 months after surgery (3-month follow-up))
- Sternal complications within 3 months after surgery(Up to 3 months after surgery (3-month follow-up))
- Cognitive dysfunction at 3 months after surgery(3 months after surgery)
- Angina within 12 months after surgery(12 months after surgery)
- Cognitive dysfunction at 12 months after surgery(12 months after surgery)
- Sternal complications within 12 months after surgery(Up to 12 months after surgery (12-month follow-up))
- Clinical stroke within 12 months after surgery(Up to 12 months after surgery (12-month follow-up))
- MACCE within 12 months after surgery(Up to 12 months after surgery (12-month follow-up))