Myocardial Bridge of Coronary ArteryNCT06857838
Myocardialbridge Bypass Graft Surgery Efficacy Verification
A study testing MBBG, MB CABG and MB unroof in people with Myocardial Bridge of Coronary Artery and Myocardial Bridge, run by Xi'an International Medical Center Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Bridge of Coronary Artery, Myocardial Bridge, Myocardial Bridging
- What is being tested?
- MBBG, MB CABG and MB unroof
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with myocardialbridge requiring drug therapy or surgical intervention.
Who cannot join
- patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xi'an International Medical Center Hospital Affiliated TO Northwest University
Xi'an, Shaanxi, 710100
Zhen Wang, Doctorate, +86-029-68302464, wang.zhen@000516.cn
Jinzhou Zhang, Doctorate, +86-029-68302464, zhang.jinzhou@000516.cn
About this study
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.
- Conditions
- Myocardial Bridge of Coronary Artery, Myocardial Bridge, Myocardial Bridging, Myocardial Infarction, Myocardial Ischemia, Pectoris, Stable Angina
- Being tested
- MBBG, MB CABG, MB unroof
- Medical subject headings
- Myocardial Bridging, Myocardial Infarction, Myocardial Ischemia, Angina, Stable, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBBGProcedure or surgery
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.
MB CABGProcedure or surgery
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.
MB unroofProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: MB unroof |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Measured: Up to 240 months
Rate of counduit patency
Measured: Up to 180 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Bridge of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an International Medical Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang zhen, Xi'an International Medical Center Hospital
- Investigators
- Zhen Wang, Doctorate, Principal investigator, Xi'an International Medical Center Hospital Affiliated To Northwest UniversityJinzhou Zhang, Doctorate, Study director, Xi'an International Medical Center Hospital Affiliated To Northwest UniversityJinzhou Zhang, Doctorate, Study chair, Xi'an International Medical Center Hospital Affiliated To Northwest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857838
- Sponsor's protocol ID
- XianInternationalMCH
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33482166
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardialbridge Bypass Graft Surgery Efficacy Verification
- ClinicalTrials.gov ID
- NCT06857838
- Acronym / sponsor ID
- XianInternationalMCH
- Conditions
- Myocardial Bridge of Coronary Artery, Myocardial Bridge, Myocardial Bridging, Myocardial Infarction, Myocardial Ischemia, Pectoris, Stable Angina
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xi'an International Medical Center HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MyocardialBridge Bypass Graft | Experimental | Procedure: MBBGThe 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 | Active comparator | Procedure: MB CABGThe 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. |
| Myocardioalbridge Unroof | Active comparator | Procedure: MB unroofThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with myocardialbridge requiring drug therapy or surgical intervention.
Key exclusion criteria (1 listed)
- patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBBGThe 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 or surgery | MyocardialBridge Bypass Graft |
| MB CABGThe 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. | Procedure or surgery | Myocardialbridge CABG |
| MB unroofThe 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. | Procedure or surgery | Myocardioalbridge Unroof |
Primary outcome
All-Cause Mortality
Time frame: Up to 240 months
Rate of counduit patency
Time frame: Up to 180 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Results publication: PubMed 33482166Zhang 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.
- The report of the preliminary short term clinical results of MBBG surgery for the first time in the worldLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhen Wang, Doctorate principal investigator
Xi'an International Medical Center Hospital Affiliated To Northwest University
Jinzhou Zhang, Doctorate study director
Xi'an International Medical Center Hospital Affiliated To Northwest University
Jinzhou Zhang, Doctorate study chair
Xi'an International Medical Center Hospital Affiliated To Northwest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBBG, MB CABG and MB unroof in people with Myocardial Bridge of Coronary Artery and Myocardial Bridge, run by Xi'an International Medical Center Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Wang, Doctorate (+86-029-68302464, wang.zhen@000516.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: Up to 240 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.