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
Inclusion Criteria7
- 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).
- Angiographic definition of MB \*
- Myocardial bridge is a congenital anomaly characterized by an intramural course of an epicardial coronary segment. This anatomical arrangement causes the artery to be squeezed during systole, with a relaxation in diastole. In this study, MB is defined as a visual ≥ 50% reduction in the minimal luminal diameter during systole and a complete or partial relaxation in diastole ("milking effect").
- The use of intracoronary vasodilators (i.e., nitrates) can increase the systolic narrowing of the vessel, through a reflex rise of the adrenergic drive, and consequently the angiographic sensitivity in detecting MB.
Exclusion Criteria11
- 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.
- Clinically significant right ventricular dysfunction.
- Known severe renal impairment (eGFR \< 30 ml/min/1.73 m2).
- Known severe hepatic impairment, or history of cirrhosis with evidence of portal hypertension.
- History of malignancy of any organ system with a life expectancy \< 1 year.
- Any previous history of ischemic stroke, intracranial haemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Pregnant or breastfeeding women.
- Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (nitrates, adenosine, dobutamine, acetylcholine).
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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