Myocardialbridge Bypass Graft Surgery Efficacy Verification

NCT ID: NCT06857838

Last Updated: 2025-03-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2040-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Bridge of Coronary Artery Myocardial Bridge Myocardial Bridging Myocardial Infarction Myocardial Ischemia Pectoris, Stable Angina Sudden Cardiac Death Bypass Graft Stenosis Bypass Graft Occlusion Bypass Graft Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

MBBG

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

MB CABG

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

MB unroof

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi'an International Medical Center Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang zhen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhen Wang, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Xi'an International Medical Center Hospital Affiliated To Northwest University

Jinzhou Zhang, Doctorate

Role: STUDY_DIRECTOR

Xi'an International Medical Center Hospital Affiliated To Northwest University

Jinzhou Zhang, Doctorate

Role: STUDY_CHAIR

Xi'an International Medical Center Hospital Affiliated To Northwest University

Locations

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Xi'an International Medical Center Hospital Affiliated TO Northwest University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen Wang, Doctorate

Role: CONTACT

+86-029-68302464

Jinzhou Zhang, Doctorate

Role: CONTACT

+86-029-68302464

Facility Contacts

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Zhen Wang, Doctorate

Role: primary

+86-029-68302464

Jinzhou Zhang, Doctorate

Role: backup

+86-029-68302464

References

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Zhang JZ, Zhu GY, Zhang Y, Bai LJ, Wang Z. Myocardial Bridge Bypass Graft: A Novel Surgical Procedure for Extensive Myocardial Bridges. Ann Thorac Surg. 2021 Aug;112(2):e115-e117. doi: 10.1016/j.athoracsur.2020.11.055. Epub 2021 Jan 20.

Reference Type BACKGROUND
PMID: 33482166 (View on PubMed)

Related Links

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http://pubmed.ncbi.nlm.nih.gov/33482166/

The report of the preliminary short term clinical results of MBBG surgery for the first time in the world

Other Identifiers

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XianInternationalMCH

Identifier Type: -

Identifier Source: org_study_id

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