protocolSection identificationModule nctId: NCT06281067, orgStudyIdInfo id: 271.673, briefTitle: Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine, acronym: RIALTO PRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, collaborators name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro", descriptionModule briefSummary: 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., conditionsModule conditions: Myocardial Bridge, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: "full-physiology approach" arm, interventions name: "standard approach" arm, outcomesModule primaryOutcomes measure: The composite of significant angina and MACE, secondaryOutcomes measure: Rate of patients with significant angina (SAQ Angina Summary Score ≤ 70), secondaryOutcomes measure: Incidence of MACE, secondaryOutcomes measure: Rate of cardiac death, secondaryOutcomes measure: Rate of MI, secondaryOutcomes measure: Rate of cardiac hospitalization, secondaryOutcomes measure: Rate of TLR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Generale Regionale F. Miulli, status: NOT_YET_RECRUITING, city: Acquaviva Delle Fonti, country: Italy, geoPoint lat: 40.89704, lon: 16.8433, locations facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo, status: NOT_YET_RECRUITING, city: Alessandria, country: Italy, geoPoint lat: 44.90924, lon: 8.61007, locations facility: Ospedale San Donato, status: NOT_YET_RECRUITING, city: Arezzo, country: Italy, geoPoint lat: 43.46276, lon: 11.88068, locations facility: ASST Papa Giovanni XXIII, status: NOT_YET_RECRUITING, city: Bergamo, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Ospedale degli Infermi di Biella, status: NOT_YET_RECRUITING, city: Biella, country: Italy, geoPoint lat: 45.56304, lon: 8.05796, locations facility: Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria, status: NOT_YET_RECRUITING, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano, status: NOT_YET_RECRUITING, city: Caserta, country: Italy, geoPoint lat: 41.07262, lon: 14.33231, locations facility: Villa Maria Cecilia Hospital, status: NOT_YET_RECRUITING, city: Cotignola, country: Italy, geoPoint lat: 44.38572, lon: 11.93852, locations facility: Azienda Ospedaliero Universitaria di Ferrara, status: NOT_YET_RECRUITING, city: Ferrara, country: Italy, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Azienda Ospedaliero Universitaria Careggi, status: NOT_YET_RECRUITING, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliera Universitaria Policlinico San Martino, status: NOT_YET_RECRUITING, city: Genova, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale Della Misericordia, status: NOT_YET_RECRUITING, city: Grosseto, country: Italy, geoPoint lat: 42.76296, lon: 11.10941, locations facility: Centro Cardiologico Monzino IRCCS, status: NOT_YET_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Ospedale Galeazzi, status: NOT_YET_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS San Gerardo dei Tintori, status: NOT_YET_RECRUITING, city: Monza, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, locations facility: AOU Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Domenico D'Amario, Prof, role: CONTACT, phone: 0039 0321 3733141, email: domenico.damario@uniupo.it, contacts name: Domenico D'Amario, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Giuseppe Patti, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Azienda Ospedaliero Universitaria di Parma, status: NOT_YET_RECRUITING, city: Parma, country: Italy, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Azienda Ospedaliera di Perugia, status: NOT_YET_RECRUITING, city: Perugia, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, locations facility: Azienda Ospedaliero Universitaria Pisana, status: NOT_YET_RECRUITING, city: Pisa, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Ospedale San Jacopo, status: NOT_YET_RECRUITING, city: Pistoia, country: Italy, geoPoint lat: 43.93064, lon: 10.92365, locations facility: Ospedali Riuniti di Rivoli, status: NOT_YET_RECRUITING, city: Rivoli, country: Italy, geoPoint lat: 45.07073, lon: 7.51465, locations facility: Aurelia Hospital, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliera San Camillo-Forlanini, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero Universitaria Sant'Andrea, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Santo Spirito, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Universitario Tor Vergata Fondazione PTV, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Civile Santissima Annunziata, status: NOT_YET_RECRUITING, city: Sassari, country: Italy, geoPoint lat: 40.72586, lon: 8.55552, locations facility: Azienda Sanitaria Provinciale di Siracusa, status: NOT_YET_RECRUITING, city: Siracusa, country: Italy, geoPoint lat: 37.08415, lon: 15.27628, locations facility: Azienda Ospedaliera Ordine Mauriziano, status: NOT_YET_RECRUITING, city: Torino, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Azienda Ospedaliero Universitaria Città Della Salute E Scienza, status: NOT_YET_RECRUITING, city: Torino, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Presidio Ospedaliero Sant'Andrea, status: NOT_YET_RECRUITING, city: Vercelli, country: Italy, geoPoint lat: 45.32163, lon: 8.41989, locations facility: Azienda Ospedaliera Universitaria Integrata, Ospedale Borgo Trento, status: NOT_YET_RECRUITING, city: Verona, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False