NCT04958395

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Status
completed

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 Start

First participant enrolled

November 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2015

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

November 1, 2014

Enrollment Period

12 months

First QC Date

June 27, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Morphological index of myocardial bridge

    The minimum lumen diameter of the target vessel

    All indicators were completed within 1 week of coronary angiography.

Secondary Outcomes (1)

  • Exercise electrocardiogram

    72 hours after coronary angiography

Study Arms (1)

Myocardial bridge

Measure FFR and d-FFR

Diagnostic Test: FFR and d-FFR

Interventions

FFR and d-FFRDIAGNOSTIC_TEST

Measure FFR and d-FFR

Myocardial bridge

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Bridging

Condition Hierarchy (Ancestors)

Coronary Vessel AnomaliesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Liyun He

    Peking University Third Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 12, 2021

Study Start

November 1, 2014

Primary Completion

October 31, 2015

Study Completion

October 31, 2015

Last Updated

July 12, 2021

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share