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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional off-pump coronary artery bypass grafting (Ao-SVG) | Active Comparator | Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp. |
|
| Aortic no-touch coronary artery bypass grafting (RIMA-SVG) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic no-touch coronary artery bypass grafting (RIMA-SVG) | Procedure | Ascending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA) |
| Measure | Description | Time Frame |
|---|---|---|
| Saphenous vein graft (SVG) occlusion rate | Assessed by coronary computed tomography angiography (CCTA) | 1 year after surgery |
| New-onset clinical stroke and silent brain infarction (SBI) | Clinical stroke and SBI assessed at 7 ± 3 days postoperatively; SBI assessed by brain magnetic resonance imaging (MRI). | 7 ± 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | The incidence of delirium evaluated by CAM/CAM-ICU | within 5 postoperative days |
| Incidence of perioperative neurocognitive disorder (PND) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment (MoCA; range 0-30 points, higher scores indicate better cognitive function). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lianxin Chen | Contact | 01088322265 | chenlianx1@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28231944 | Result | Zhao DF, Edelman JJ, Seco M, Bannon PG, Wilson MK, Byrom MJ, Thourani V, Lamy A, Taggart DP, Puskas JD, Vallely MP. Coronary Artery Bypass Grafting With and Without Manipulation of the Ascending Aorta: A Network Meta-Analysis. J Am Coll Cardiol. 2017 Feb 28;69(8):924-936. doi: 10.1016/j.jacc.2016.11.071. | |
| 31735394 | Result |
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| Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG) | Procedure | Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp. |
|
| within 7 days after surgery |
| Perioperative major adverse cardiovascular and cerebrovascular events (MACCE) | Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization. | within 30 postoperative days |
| MACCE within 3 months after surgery | Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization. | 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 | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment (MoCA; range 0-30 points, higher scores indicate better cognitive function). | 3 months after surgery |
| Angina within 12 months after surgery | Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 12 months post CABG | 12 months after surgery |
| Cognitive dysfunction at 12 months after surgery | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment (MoCA; range 0-30 points, higher scores indicate better cognitive function). | 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 | Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization. | Up to 12 months after surgery (12-month follow-up) |
| Peking University First Hospita | Not yet recruiting | Beijing | China |
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| Qingdao Cardiovascular Hospital | Not yet recruiting | Qingdao | China |
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| Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen | Not yet recruiting | Shenzhen | China |
|
| Tachibana H, Hiraoka A, Saito K, Naito Y, Chikazawa G, Tamura K, Totsugawa T, Yoshitaka H, Sakaguchi T. Incidence and impact of silent brain lesions after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2021 Feb;161(2):636-644. doi: 10.1016/j.jtcvs.2019.09.162. Epub 2019 Oct 16. |