Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG: A Randomized Trial

N/ANot Yet RecruitingNCT07302659

China National Center for Cardiovascular Diseases380 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

380

Conditions

Coronary Artery Bypass Graft (CABG)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, China

Peking University First Hospita

Beijing, China

Qingdao Cardiovascular Hospital

Qingdao, China

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, China

Outcomes

Primary Outcomes

Saphenous vein graft (SVG) occlusion rate

Assessed by coronary computed tomography angiography (CCTA)

Time frame: 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).

Time frame: 7 ± 3 days after surgery

Secondary Outcomes

Incidence of postoperative delirium

The incidence of delirium evaluated by CAM/CAM-ICU

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Up to 3 months after surgery (3-month follow-up)

Clinical stroke within 3 months after surgery

Time frame: Up to 3 months after surgery (3-month follow-up)

Sternal complications within 3 months after surgery

Time frame: 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).

Time frame: 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

Time frame: 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).

Time frame: 12 months after surgery

Sternal complications within 12 months after surgery

Time frame: Up to 12 months after surgery (12-month follow-up)

Clinical stroke within 12 months after surgery

Time frame: 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.

Time frame: Up to 12 months after surgery (12-month follow-up)

Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG: A Randomized Trial

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts