About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- "full-physiology approach" arm
- "standard approach" arm
Treatment groups
Sponsors and collaborators
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