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RECRUITING
NCT06281067
NA

Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine

Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

"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).

DIAGNOSTIC_TEST

"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