Evaluation of the Hemodynamic Significance of Myocardial Bridge by Coronary Blood Fractional Flow Reserve
July 8, 2021 updated by: Peking University Third Hospital
This study clarified the influence of myocardial bridge on coronary hemodynamics by clarifying FFR and d-FFR to guide clinical intervention and treatment.
Study Overview
Status
Completed
Conditions
Intervention / 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 Type
Observational
Enrollment (Actual)
20
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Uncontrolled hypertension or systolic blood pressure <100mmHg;
- Asthma or severe chronic obstructive pulmonary disease;
- Severe liver and kidney dysfunction;
- Allergic to contrast agents.
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Myocardial bridge
Measure FFR and d-FFR
|
Measure FFR and d-FFR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
All indicators were completed within 1 week of coronary angiography.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise electrocardiogram
Time Frame: 72 hours after coronary angiography
|
ST segment depression time
|
72 hours after coronary angiography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Liyun He, Peking University Third Hospital
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)
November 1, 2014
Primary Completion (Actual)
October 31, 2015
Study Completion (Actual)
October 31, 2015
Study Registration Dates
First Submitted
June 27, 2021
First Submitted That Met QC Criteria
July 8, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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