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Optimizing treatment for myocardial bridge patients

Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine: RIALTO PRO

NA · Azienda Ospedaliero Universitaria Maggiore della Carita · NCT06281067

This study is testing whether a personalized treatment plan can help people with myocardial bridge feel better compared to the usual standard care.

Quick facts

PhaseNA
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita (other)
Locations34 sites (Acquaviva delle Fonti and 33 other locations)
Trial IDNCT06281067 on ClinicalTrials.gov

What this trial studies

The RIALTO-PRO study aims to enhance the diagnostic and therapeutic strategies for patients with myocardial bridge (MB) by comparing a personalized management approach to a standard one. Patients diagnosed with MB during coronary angiography will be randomly assigned to either a full-physiology approach, which includes a comprehensive diagnostic algorithm, or a standard approach focused on angiographic evaluation. The study will utilize advanced diagnostic tools to assess hemodynamics and tailor treatment based on individual patient needs. This multicenter, prospective trial seeks to determine the prognostic value of these approaches in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with myocardial bridge and exhibiting symptoms of inducible ischemia.

Not a fit: Patients with moderate to severe coronary artery disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with myocardial bridge.

How similar studies have performed: While the approach is innovative, similar studies have shown promise in optimizing treatment for coronary conditions, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Acquaviva delle Fonti and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Myocardial Bridge, myocardial bridge, Personalized Medicine

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.