Myocardialbridge Bypass Graft Surgery Efficacy Verification

February 26, 2025 updated by: Wang zhen, Xi'an International Medical Center Hospital
Myocardial Bridge Bypass Graft surgery is introduced to relieve the unmedical symptoms of patients with long-segment or deep myocardial bridge, clinical outcomes will be collected to verify the effectiveness of the surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710100
        • Recruiting
        • Xi'an International Medical Center Hospital Affiliated TO Northwest University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with myocardialbridge requiring drug therapy or surgical intervention.

Exclusion Criteria:

  • patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyocardialBridge Bypass Graft
The patients with deep(depth>2mm) and long-segement(length>25mm) of myocardialbridge receiving myocardialbridge bypass graft surgery(MBBG)，fulfilling the following criteria: 1.presenting with pectoris angina that cannot be effectively relieved by maximum guideline-directed drug therapy; 2. No atherosclerotic plaque or merely mild atherosclerotic stenosis is detected at the proximal or entry of the myocardialbridge confirmed by coronory artery angiography.
Procedure: MBBG
The patients with deep(depth>2mm) and long-segement(length>25mm) of myocardialbridge receiving myocardialbridge bypass graft surgery(MBBG)，fulfilling the following criteria: 1.presenting with pectoris angina that cannot be effectively relieved by maximum guideline-directed drug therapy; 2. No atherosclerotic plaque or merely mild atherosclerotic stenosis is detected at the proximal or entry of the myocardialbridge confirmed by coronory artery angiography.
Active Comparator: Myocardialbridge CABG
The patients with deep(depth>2mm) and long-segement(length>25mm) of myocardialbridge will be allocated to receive myocardialbridge bypass graft surgery(MBBG)，when fulfilling the following criteria: 1.presenting with pectoris angina that cannot be effectively relieved by maximum guideline-directed drug therapy; 2. The moderate-to-severe atherosclertotic stenosis is detected at the proximal or entry of the myocardialbridge confirmed by coronory artery angiography.
Procedure: MB CABG
The patients with deep(depth>2mm) and long-segement(length>25mm) of myocardialbridge receiving myocardialbridge bypass graft surgery(MBBG)，fulfilling the following criteria: 1.presenting with pectoris angina that cannot be effectively relieved by maximum guideline-directed drug therapy; 2. The moderate-to-severe atherosclerotic stenosis is detected at the proximal or entry of the myocardialbridge confirmed by coronory artery angiography.
Active Comparator: Myocardioalbridge Unroof
The patients with superficial type(depth<2mm) and short-segement(length<25mm) of myocardial bridge will be allocated to receive "unroof" surgery，when fulfilling the following criteria: 1.presenting with pectoris angina that cannot be effectively relieved by maximum guideline-directed drug therapy; 2. No atherosclerotic plaque or merely mild atherosclerotic stenosis is detected at the proximal or entry end of the myocardialbridge confirmed by coronory artery angiography.
Procedure: MB unroof
The patients with superficial type(depth<2mm) and short-segement(length<25mm) of myocardial bridge will be allocated to receive myocardialbridge "unroof" surgery，when fulfilling the following criteria: 1.presenting with pectoris angina that cannot be effectively relieved by maximum guideline-directed drug therapy; 2. The MB was superficial and short confirmed by coronory artery CT angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-Cause Mortality
Time Frame: Up to 240 months
Up to 240 months
Rate of counduit patency
Time Frame: Up to 180 months
Up to 180 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xi'an International Medical Center Hospital

Investigators

  • Principal Investigator: Zhen Wang, Doctorate, Xi'an International Medical Center Hospital Affiliated TO Northwest University
  • Study Director: Jinzhou Zhang, Doctorate, Xi'an International Medical Center Hospital Affiliated TO Northwest University
  • Study Chair: Jinzhou Zhang, Doctorate, Xi'an International Medical Center Hospital Affiliated TO Northwest University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XianInternationalMCH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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