About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Aortic no-touch coronary artery bypass grafting (RIMA-SVG)
Procedure/SurgeryAscending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA)
Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG)
Procedure/SurgeryOff-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.
Treatment groups
Trial outcomes
Primary outcomes
Saphenous vein graft (SVG) occlusion rate
Assessed by coronary computed tomography angiography (CCTA)
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).
Secondary outcomes
Incidence of postoperative delirium
The incidence of delirium evaluated by CAM/CAM-ICU
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).
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.
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.
Sponsors and contacts
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