NCT05111418

Brief Summary

Myocardial bridge (MB) is a congenital anomaly of epicardial circulation characterized by an intramural course of a coronary segment. This anatomical arrangement causes the artery to be squeezed during systole potentially causing flow impairment and ischemia. For this study, MB is defined as the presence of systolic compression in an epicardial vessel causing at least 50% of caliber reduction from diastole. MB can be disabling as it worsens the quality of life. Early detection of this congenital condition is crucial, and an invasive functional assessment of the ischemic burden should be considered to evaluate the need for medical or surgical therapy. This is an observational study, involving four Italian centres. Study Objectives are: To assess the risk of future cardiovascular complications in patients with MB referred for coronary angiography and the role of beta-blocker therapy; To describe the clinical and anatomical characteristics of patients presenting with MB; To determine the impact of cardiovascular medications on symptoms in patients with MB; To describe the anatomical and clinical features associated with the invasive evidence of ischemia in patients with MB; To assess the relation between invasively documented ischemia and clinical manifestations in patients with the MB. Inclusion Criteria: patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have an MB with or without other epicardial lesions amenable to revascularization; Age above 18 y.o.; Ability to provide Informed Consent. Exclusion Criteria are Patients with life expectancy below 12 months and Patients with severe valvular heart disease. The primary endpoint is the incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization, and target vessel revascularization. The secondary endpoint is evaluating the Rate of patients with SAQ \< 70 and the Rate of patients with "high-risk features" on CT scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

5 active sites

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

March 17, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

October 27, 2021

Last Update Submit

July 9, 2024

Conditions

Myocardial Bridge

Keywords

Myocardial BridgeMACEIschemiaBeta-blockersCoronary angiographyPersonalised medicine

Outcome Measures

Primary Outcomes (1)

  • Incidence of MACE

    Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization

    2 years follow up

Secondary Outcomes (2)

  • Rate of patients with SAQ < 70

    2 years follow up

  • Rate of patients with "high risk features" on CT scan

    2 years follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population with suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization

You may qualify if:

  • Patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization
  • Age above 18 y.o.
  • Ability to provide Informed Consent

You may not qualify if:

  • Patients with life expectancy below 12 months
  • Patients with severe valvular heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara

Ferrara, Italia, 44124, Italy

Location

Policlinico S. Martino IRCCS, Università di Genova

Genova, Italia, 16132, Italy

Location

Centro Cardiologico Monzino IRCCS

Milan, Italia, 20138, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italia, 00168, Italy

Location

Policlinico Universitario Tor Vergata Fondazione PTV

Roma, Italy

Location

MeSH Terms

Conditions

Myocardial BridgingIschemia

Condition Hierarchy (Ancestors)

Coronary Vessel AnomaliesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

March 17, 2021

Primary Completion

March 17, 2022

Study Completion

March 17, 2023

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

IT(5)