Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine: RIALTO PRO
Azienda Ospedaliero Universitaria Maggiore della Carita
500 participants
Dec 15, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
* 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).
In the "standard approach" arm patients will undergo an angiographic evaluation of the tunnelled artery
Locations(34)
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NCT06281067