Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry

NCT ID: NCT05111418

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

444 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-17

Study Completion Date

2023-03-17

Brief Summary

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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

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Conditions

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Myocardial Bridge

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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DAMARIO DOMENICO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara

Ferrara, Italia, Italy

Site Status

Policlinico S. Martino IRCCS, Università di Genova

Genova, Italia, Italy

Site Status

Centro Cardiologico Monzino IRCCS

Milan, Italia, Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italia, Italy

Site Status

Policlinico Universitario Tor Vergata Fondazione PTV

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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3812

Identifier Type: -

Identifier Source: org_study_id

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