NCT06281067 Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
| NCT ID | NCT06281067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita |
| Condition | Myocardial Bridge |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2023-12-15 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Ability to give informed consent to the study. 2. Age ≥ 18 years and ≤ 75 years. 3. Diagnosis of MB during index coronary angiography\*. 4. 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 Criteria: 1. Moderate to severe CAD (≥ 50% stenosis in any vessel, including chronic total occlusion) at the time of enrolment/randomization. 2. Previous CABG involving the index vessel. 3. Severe valvular heart disease. 4. Left ventricular systolic dysfunction \[ejection fraction (EF) \< 40%\], regardless of the etiology. 5. Clinically significant right ventricular dysfunction. 6. Known severe renal impairment (eGFR \< 30 ml/min/1.73 m2). 7. Known severe hepatic impairment, or history of cirrhosis with evidence of portal hypertension. 8. History of malignancy of any organ system with a life expectancy \< 1 year. 9. Any previous history of ischemic stroke, intracranial haemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm). 10. Pregnant or breastfeeding women. 11. Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (nitrates, adenosine, dobutamine, acetylcholine).
Contact & Investigator
Giuseppe Patti, Prof
STUDY CHAIR
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Frequently Asked Questions
Who can join the NCT06281067 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Myocardial Bridge. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06281067 currently recruiting?
Yes, NCT06281067 is actively recruiting participants. Contact the research team at domenico.damario@uniupo.it for enrollment information.
Where is the NCT06281067 trial being conducted?
This trial is being conducted at Acquaviva delle Fonti, Italy, Alessandria, Italy, Arezzo, Italy, Bergamo, Italy and 11 additional locations.
Who is sponsoring the NCT06281067 clinical trial?
NCT06281067 is sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. The principal investigator is Giuseppe Patti, Prof at Università degli Studi del Piemonte Orientale Amedeo Avogadro. The trial plans to enroll 500 participants.