NCT06857838

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
179mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jan 2020Dec 2040

Study Start

First participant enrolled

January 1, 2020

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

11 years

First QC Date

February 20, 2025

Last Update Submit

February 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • All-Cause Mortality

    Up to 240 months

  • Rate of counduit patency

    Up to 180 months

Study Arms (3)

MyocardialBridge Bypass Graft

EXPERIMENTAL

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

Myocardialbridge CABG

ACTIVE COMPARATOR

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

Myocardioalbridge Unroof

ACTIVE COMPARATOR

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

Interventions

MBBGPROCEDURE

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 Bypass Graft
MB CABGPROCEDURE

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.

Myocardialbridge CABG
MB unroofPROCEDURE

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.

Myocardioalbridge Unroof

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with myocardialbridge requiring drug therapy or surgical intervention.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi'an International Medical Center Hospital Affiliated TO Northwest University

Xi'an, Shaanxi, 710100, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33482166BACKGROUND

Related Links

MeSH Terms

Conditions

Myocardial BridgingMyocardial InfarctionMyocardial IschemiaAngina, StableDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Coronary Vessel AnomaliesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsHeart ArrestDeath, SuddenDeath

Study Officials

  • Zhen Wang, Doctorate

    Xi'an International Medical Center Hospital Affiliated To Northwest University

    PRINCIPAL INVESTIGATOR
  • Jinzhou Zhang, 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

Central Study Contacts

Zhen Wang, Doctorate

CONTACT

Jinzhou Zhang, Doctorate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 4, 2025

Study Start

January 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations