Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting

NCT ID: NCT07302659

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Bypass Graft (CABG)

Keywords

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coronary artery bypass graft Silent Brain Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional off-pump coronary artery bypass grafting (TA-SVG)

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Ascending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA)

Interventions

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Aortic 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Peking University First Hospita

Beijing, , China

Site Status

Qingdao Cardiovascular Hospital

Qingdao, , China

Site Status

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, , China

Site Status

Countries

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China

Central Contacts

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Lianxin Chen

Role: CONTACT

Phone: 01088322265

Email: [email protected]

Facility Contacts

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Chen

Role: primary

Wang

Role: primary

Feng

Role: primary

Nie

Role: primary

References

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Zhao DF, Edelman JJ, Seco M, Bannon PG, Wilson MK, Byrom MJ, Thourani V, Lamy A, Taggart DP, Puskas JD, Vallely MP. Coronary Artery Bypass Grafting With and Without Manipulation of the Ascending Aorta: A Network Meta-Analysis. J Am Coll Cardiol. 2017 Feb 28;69(8):924-936. doi: 10.1016/j.jacc.2016.11.071.

Reference Type RESULT
PMID: 28231944 (View on PubMed)

Tachibana H, Hiraoka A, Saito K, Naito Y, Chikazawa G, Tamura K, Totsugawa T, Yoshitaka H, Sakaguchi T. Incidence and impact of silent brain lesions after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2021 Feb;161(2):636-644. doi: 10.1016/j.jtcvs.2019.09.162. Epub 2019 Oct 16.

Reference Type RESULT
PMID: 31735394 (View on PubMed)

Other Identifiers

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2023ZD0504701

Identifier Type: -

Identifier Source: org_study_id