Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry

Completed

• Conditions: Myocardial Bridge

• Registration Number: NCT05111418
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-17
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-08
• Primary Completion: 2022-03-17
• Study Completion: 2023-03-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of MACE	2 years follow up	Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Rate of patients with "high risk features" on CT scan	2 years follow up	High risk features
Rate of patients with SAQ < 70	2 years follow up

Trial Locations

Locations (5)

Centro Cardiologico Monzino IRCCS; 🇮🇹 Milano, Italia, Italy

Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara; 🇮🇹 Ferrara, Italia, Italy

Policlinico Universitario Tor Vergata Fondazione PTV; 🇮🇹 Roma, Italy

Policlinico S. Martino IRCCS, Università di Genova; 🇮🇹 Genova, Italia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italia, Italy