Coronary Artery Bypass Graft (CABG)
Conditions
Keywords
coronary artery bypass graft, Silent Brain Infarction
Brief summary
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.
Interventions
PROCEDUREAortic no-touch coronary artery bypass grafting (RIMA-SVG)
Ascending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA)
PROCEDUREConventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG)
Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Saphenous vein graft (SVG) occlusion rate | 1 year after surgery | Assessed by coronary computed tomography angiography (CCTA) |
| New-onset clinical stroke and silent brain infarction (SBI) | 7 ± 3 days after surgery | Clinical stroke and SBI assessed at 7 ± 3 days postoperatively; SBI assessed by brain magnetic resonance imaging (MRI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | within 5 postoperative days | The incidence of delirium evaluated by CAM/CAM-ICU |
| Incidence of perioperative neurocognitive disorder (PND) | within 7 days 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). |
| Perioperative major adverse cardiovascular and cerebrovascular events (MACCE) | within 30 postoperative days | 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 | Up to 3 months after surgery (3-month follow-up) | Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization. |
| 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 | 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). |
| Angina within 12 months after surgery | 12 months after surgery | Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 12 months post CABG |
| Cognitive dysfunction at 12 months after surgery | 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). |
| 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) | Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization. |
Countries
China
Contacts
CONTACTLianxin Chen
Outcome results
None listed