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Completed

NCT Number: NCT04958395

Evaluation of the Hemodynamic Significance of Myocardial Bridge by Coronary Blood Fractional Flow Reserve

This study clarified the influence of myocardial bridge on coronary hemodynamics by clarifying FFR and d-FFR to guide clinical intervention and treatment.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FFR and d-FFR

Diagnostic Test

Measure FFR and d-FFR

Primary outcomes

  1. 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

Secondary outcomes

  1. Exercise electrocardiogram

    Time frame: 72 hours after coronary angiography

    ST segment depression time

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2021
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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