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Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting (PROTECT-CABG)

N

National Center for Cardiovascular Diseases

Status

Not yet enrolling

Conditions

Coronary Artery Bypass Graft (CABG)

Treatments

Procedure: Aortic no-touch coronary artery bypass grafting (RIMA-SVG)

Study type

Interventional

Funder types

Other

Identifiers

NCT07302659
2023ZD0504701

Details and patient eligibility

About

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.

Enrollment

380 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

380 participants in 2 patient groups

Traditional off-pump coronary artery bypass grafting (TA-SVG)
No Intervention group
Aortic no-touch coronary artery bypass grafting (RIMA-SVG)
Experimental group
Treatment:
Procedure: Aortic no-touch coronary artery bypass grafting (RIMA-SVG)

Trial contacts and locations

4

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Central trial contact

Lianxin Chen

Data sourced from clinicaltrials.gov

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