The "RIALTO-PRO" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB.
The "RIALTO PRO" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a "full-physiology approach", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a "standard approach", consisting of angiographic evaluation of the tunnelled segment.
Ability to give informed consent to the study.
Age ≥ 18 years and ≤ 75 years.
Diagnosis of MB during index coronary angiography*.
Symptoms or signs of inducible ischemia (if signs, these should involve the territory of the index vessel).
Moderate to severe CAD (≥ 50% stenosis in any vessel, including chronic total occlusion) at the time of enrolment/randomization.
Previous CABG involving the index vessel.
Severe valvular heart disease.
Left ventricular systolic dysfunction [ejection fraction (EF) < 40%], regardless of the etiology.
Parallel
"full-physiology approach" arm
Diagnostic test* All MB patients belonging to the full-physiology arm will undergo functional assessment of the intramural artery with basal Pd/Pa, FFR (after intravenous adenosine), RFR, CFR and IMR. * In the presence of a negative functional assessment (Pd/Pa\> 0.92, FFR\> 0.80, RFR\> 0.89, CFR≥ 2.0 and IMR\< 25), FFR, CFR and IMR will be measured after inotropic stimulation with dobutamine (respectively FFR-d, CFR-d and IMR-d) to exalt the epicardial hemodynamic significance of MB or its impact on structural microvascular remodelling (impaired endothelium-independent vasodilatation). * In the absence of epicardial hemodynamic significance (FFR-d\> 0.75) and structural microvascular dysfunction (CFR≥ 2.0 and IMR\< 25), ACH provocative test will be performed to evaluate the presence of epicardial or microvascular spasm (impaired endothelium-dependent vasodilatation).
"standard approach" arm
Diagnostic testIn the "standard approach" arm patients will undergo an angiographic evaluation of the tunnelled artery
The composite of significant angina and MACE
Composite of significant anginal burden, defined as Seattle angina questionnaire (SAQ) Summary Score ≤ 70, and MACE, defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization (any cause) and target vessel revascularization at 1 year follow-up.
Rate of patients with significant angina (SAQ Angina Summary Score ≤ 70)
Incidence of MACE
Rate of cardiac death
Rate of MI
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Azienda Ospedaliero Universitaria Maggiore della Carita
Lead sponsor
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Sponsor institution
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborator
