Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07302659

Surgical Techniques to Prevent Neurologic Complications in Coronary Artery Bypass Grafting Comparing Aortic No-Touch and Partial Aortic Clamping

Led by China National Center for Cardiovascular Diseases · Updated on 2026-04-14

380

Participants Needed

4

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating surgical approaches to reduce brain-related complications during coronary artery bypass grafting (CABG) in patients with coronary artery disease. This multicenter, randomized controlled trial aims to improve outcomes and quality of life by comparing a new aortic no-touch technique with the conventional partial clamping method. The study focuses on lowering silent brain infarction and other neurological risks during surgery. The trial compares two surgical methods for off-pump CABG: one uses a partial clamp on the ascending aorta to connect the saphenous vein graft, while the other avoids any aortic manipulation by attaching the vein graft to the right internal mammary artery as a composite graft. These two approaches will be assessed for safety and effectiveness in preventing brain injury and other cardiovascular events. Participants will undergo surgery followed by detailed assessments including neurocognitive tests and MRI scans within the first week after surgery to detect brain infarcts or strokes. Researchers will monitor outcomes such as graft blockage, cognitive function, delirium, and major cardiac or cerebrovascular events for up to one year. Safety and quality of life measures will be evaluated throughout the study period to understand the impact of each surgical strategy.

CONDITIONS

Brief Title

Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old
  • Diagnosed with multivessel coronary artery disease
  • Scheduled for isolated off-pump coronary artery bypass grafting
  • Able and willing to provide informed consent to participate
Not Eligible

You will not qualify if you...

  • Need for cardiopulmonary bypass surgery or no contraindications to on-pump surgery
  • Unsuitability of the great saphenous vein for grafting
  • Subclavian artery stenosis or occlusion, or contraindication to use of internal mammary artery
  • History of previous cardiac surgery
  • Emergency surgery cases
  • Severe ascending aortic calcification preventing aortic clamp application
  • Inability to tolerate MRI or contraindications to MRI (e.g., pacemaker, known intolerance)
  • Inability to complete neurocognitive testing due to language, vision, or hearing impairments

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 7 days after surgery

Participants undergo one of two surgical procedures for off-pump coronary artery bypass grafting to prevent neurologic complications.

1 surgery visit and daily hospital visits during immediate post-operative care

Post-operative Follow-up

Duration - Up to 12 months after surgery

Participants are monitored and assessed for neurologic and cardiovascular outcomes following surgery.

Multiple visits including assessments at 7 days, 30 days, 3 months, and 12 months post-surgery

Trial Site Locations

Total: 4 locations

1

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, China

Actively Recruiting

2

Peking University First Hospita

Beijing, China

Not Yet Recruiting

3

Qingdao Cardiovascular Hospital

Qingdao, China

Not Yet Recruiting

4

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, China

Not Yet Recruiting

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Research Team

L

Lianxin Chen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Coronary Artery Bypass Grafting With and Without Manipulation of the Ascending Aorta: A Network Meta-Analysis.

Dong Fang Zhao, J James Edelman, Michael Seco...

https://pubmed.ncbi.nlm.nih.gov/28231944