Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry (RIALTO)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Bridge

• Study Type: Observational
• Enrollment (Actual): 444

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Policlinico Universitario Tor Vergata Fondazione PTV
  • Italia
    • Ferrara, Italia, Italy, 44124
      • Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara
    • Genova, Italia, Italy, 16132
      • Policlinico S. Martino IRCCS, Università di Genova
    • Milano, Italia, Italy, 20138
      • Centro Cardiologico Monzino IRCCS
    • Roma, Italia, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with SAQ < 70		2 years follow up
Rate of patients with "high risk features" on CT scan	High risk features	2 years follow up

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Coronary angiography; Ischemia; Beta-blockers; MACE; Personalised medicine; Myocardial Bridge
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Coronary Vessel Anomalies; Myocardial Bridging
• Other Study ID Numbers: 3812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No