Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry

Myocardial Bridge Clinical Trial

— RIALTO  

Official title:

Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111418
• Other study ID #: 3812
• Status: Completed
• Start date: March 17, 2021
• Est. completion date: March 17, 2023

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Bridge
• Myocardial Bridging

Locations

Country	Name	City	State
Italy	Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara	Ferrara	Italia
Italy	Policlinico S. Martino IRCCS, Università di Genova	Genova	Italia
Italy	Centro Cardiologico Monzino IRCCS	Milano	Italia
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MACE	Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization	12 months
Secondary	Rate of patients with SAQ < 70		12 months
Secondary	Rate of patients with "high risk features" on CT scan	High risk features	12 months