Clinical trial NCT05111418: Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry
Official title: Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Bridge
Keywords: Myocardial Bridge
MACE
Ischemia
Beta-blockers
Coronary angiography
Personalised medicine
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of MACE
timeFrame: 2 years follow up
Secondary outcomes:
measure: Rate of patients with SAQ < 70
timeFrame: 2 years follow up
measure: Rate of patients with "high risk features" on CT scan
timeFrame: 2 years follow up
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara
state: Italia
city: Genova
country: Italy
facility: Policlinico S. Martino IRCCS, Università di Genova
state: Italia
city: Milano
country: Italy
facility: Centro Cardiologico Monzino IRCCS
state: Italia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Italia
city: Roma
country: Italy
facility: Policlinico Universitario Tor Vergata Fondazione PTV
Study officials:
References: