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Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Summary
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.
Official title: Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine: RIALTO PRO
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2023-12-15
Completion Date
2026-01-01
Last Updated
2024-07-10
Healthy Volunteers
No
Conditions
Interventions
"full-physiology approach" arm
* 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
In the "standard approach" arm patients will undergo an angiographic evaluation of the tunnelled artery
Locations (34)
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Italy
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale San Donato
Arezzo, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
Ospedale degli Infermi di Biella
Biella, Italy
Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria
Bologna, Italy
Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano
Caserta, Italy
Villa Maria Cecilia Hospital
Cotignola, Italy
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Azienda Ospedaliera Universitaria Policlinico San Martino
Genova, Italy
Ospedale Della Misericordia
Grosseto, Italy
Centro Cardiologico Monzino IRCCS
Milan, Italy
IRCCS Ospedale Galeazzi
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
AOU Maggiore della Carità
Novara, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Ospedale San Jacopo
Pistoia, Italy
Ospedali Riuniti di Rivoli
Rivoli, Italy
Aurelia Hospital
Roma, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, Italy
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Ospedale Sandro Pertini
Roma, Italy
Ospedale Santo Spirito
Roma, Italy
Policlinico Universitario Tor Vergata Fondazione PTV
Roma, Italy
Ospedale Civile Santissima Annunziata
Sassari, Italy
Azienda Sanitaria Provinciale di Siracusa
Syracuse, Italy
Azienda Ospedaliera Ordine Mauriziano
Torino, Italy
Azienda Ospedaliero Universitaria Città Della Salute E Scienza
Torino, Italy
Presidio Ospedaliero Sant'Andrea
Vercelli, Italy
Azienda Ospedaliera Universitaria Integrata, Ospedale Borgo Trento
Verona, Italy