Myocardial BridgeNCT04958395
Evaluation of the Hemodynamic Significance of Myocardial Bridge by Coronary Blood Fractional Flow Reserve
An observational study of Myocardial Bridge, run by Peking University Third Hospital.
Trial summary
This study clarified the influence of myocardial bridge on coronary hemodynamics by clarifying FFR and d-FFR to guide clinical intervention and treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Bridge
- What is being tested?
- FFR and d-FFR
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 31 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators enrolled patients with LAD simple myocardial bridge after other interventional treatments for vascular lesions or FFR testing to exclude functionally significant lesions.
Who may be able to join
- Patients with chest pain aged ≥18 years old, regardless of gender;
- Coronary angiography shows a solitary myocardial bridge with systolic diameter stenosis ≥30% in LAD;
- Have the ability to complete an ECG exercise test;
- Sign informed consent and are willing to participate in the intended study.
Who cannot join
- Patients with acute coronary syndrome;
- Coronary angiography shows that the diameter of atherosclerosis in the non-myocardial bridge area of LAD is ≥30%;
- RCA or LCX has severe fixed stenosis, diameter stenosis ≥70% or FFR<0.75, and no interventional therapy is accepted;
- Hypertrophic obstructive cardiomyopathy or more than moderate heart valve disease;
- Atrial fibrillation or severe slow or rapid arrhythmia;
- Heart failure with NYHA ≥ Grade III;
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- Uncontrolled hypertension or systolic blood pressure <100mmHg;
- Asthma or severe chronic obstructive pulmonary disease;
- Severe liver and kidney dysfunction;
- Allergic to contrast agents.
About this study
This study clarified the influence of myocardial bridge on coronary hemodynamics by clarifying FFR and d-FFR to guide clinical intervention and treatment.
Read the detailed description
Myocardial bridge is a congenital anatomical abnormality, which is generally considered to be a benign change, but individual can cause angina, myocardial infarction and even sudden death. Previously, it was believed that the degree of myocardial ischemia induced by myocardial bridge was related to factors such as the location, length, and systolic stenosis of the myocardial bridge shown by coronary angiography.However, in recent years, more and more evidence has suggested that there is a high degree of mismatch between anatomical stenosis and its function.Studies have shown that FFR and d-FFR can accurately evaluate the functional significance of stenotic lesions.This study intends to enroll patients who underwent coronary angiography due to chest pain and confirmed the left anterior descending artery (LAD) simple myocardial bridge systolic stenosis ≥30%, and the pressure guide wire was used to measure the FFR and d-FFR of the myocardial bridge lesion under static and dobutamine stress.Analyze the relationship between these functional parameters and the anatomical morphological characteristics of the myocardial bridge and other possible clinical influencing factors, and explore the influence of the morphological characteristics of the myocardial bridge on myocardial hemodynamics，so as to clarify the degree of myocardial bridge shown by angiography may induce obvious myocardial ischemia, which requires clinical intensive intervention.
- Conditions
- Myocardial Bridge
- Being tested
- FFR and d-FFR
- Medical subject headings
- Myocardial Bridging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR and d-FFRDiagnostic test
Measure FFR and d-FFR
| Study group | Role | What they receive |
|---|---|---|
| Myocardial bridge | Measure FFR and d-FFR Receives: Diagnostic Test: FFR and d-FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological index of myocardial bridge
The minimum lumen diameter of the target vessel
Measured: All indicators were completed within 1 week of coronary angiography.
Secondary outcomes (1)
Exercise electrocardiogram
ST segment depression time
Measured: 72 hours after coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Nov 2014
- Primary completion31 Oct 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial BridgeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liyun He, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958395
- Sponsor's protocol ID
- 2014188
- Status last verified
- Nov 2014
- First submitted
- 27 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemodynamic Significance of Myocardial Bridge by Coronary Blood Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT04958395
- Acronym / sponsor ID
- 2014188
- Conditions
- Myocardial Bridge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 12 Jul 2021 (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.
This study clarified the influence of myocardial bridge on coronary hemodynamics by clarifying FFR and d-FFR to guide clinical intervention and treatment.
Detailed description
Myocardial bridge is a congenital anatomical abnormality, which is generally considered to be a benign change, but individual can cause angina, myocardial infarction and even sudden death. Previously, it was believed that the degree of myocardial ischemia induced by myocardial bridge was related to factors such as the location, length, and systolic stenosis of the myocardial bridge shown by coronary angiography.However, in recent years, more and more evidence has suggested that there is a high degree of mismatch between anatomical stenosis and its function.Studies have shown that FFR and d-FFR can accurately evaluate the functional significance of stenotic lesions.This study intends to enroll patients who underwent coronary angiography due to chest pain and confirmed the left anterior descending artery (LAD) simple myocardial bridge systolic stenosis ≥30%, and the pressure guide wire was used to measure the FFR and d-FFR of the myocardial bridge lesion under static and dobutamine stress.Analyze the relationship between these functional parameters and the anatomical morphological characteristics of the myocardial bridge and other possible clinical influencing factors, and explore the influence of the morphological characteristics of the myocardial bridge on myocardial hemodynamics，so as to clarify the degree of myocardial bridge shown by angiography may induce obvious myocardial ischemia, which requires clinical intensive intervention.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial bridge | – | Diagnostic Test: FFR and d-FFRMeasure FFR and d-FFR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators enrolled patients with LAD simple myocardial bridge after other interventional treatments for vascular lesions or FFR testing to exclude functionally significant lesions.
Key inclusion criteria (4 listed)
- Patients with chest pain aged ≥18 years old, regardless of gender;
- Coronary angiography shows a solitary myocardial bridge with systolic diameter stenosis ≥30% in LAD;
- Have the ability to complete an ECG exercise test;
- Sign informed consent and are willing to participate in the intended study.
Key exclusion criteria (10 listed)
- Patients with acute coronary syndrome;
- Coronary angiography shows that the diameter of atherosclerosis in the non-myocardial bridge area of LAD is ≥30%;
- RCA or LCX has severe fixed stenosis, diameter stenosis ≥70% or FFR<0.75, and no interventional therapy is accepted;
- Hypertrophic obstructive cardiomyopathy or more than moderate heart valve disease;
- Atrial fibrillation or severe slow or rapid arrhythmia;
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 |
|---|---|---|
| FFR and d-FFRMeasure FFR and d-FFR | Diagnostic test | Myocardial bridge |
Primary outcome
Morphological index of myocardial bridge
Time frame: All indicators were completed within 1 week of coronary angiography.
The minimum lumen diameter of the target vessel
1 secondary outcome
Exercise electrocardiogram
Time frame: 72 hours after coronary angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Myocardial Bridge
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Myocardialbridge Bypass Graft Surgery Efficacy Verification
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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. This study is not recruiting at the moment.
Liyun He study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Bridge, run by Peking University Third Hospital.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological index of myocardial bridge (time frame: All indicators were completed within 1 week of coronary angiography.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2021.