Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
RIALTO PRO
1 other identifier
interventional
500
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Typical duration for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2023
CompletedFirst Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedJuly 10, 2024
July 1, 2024
2 years
February 15, 2024
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The composite of significant angina and MACE
Composite of significant anginal burden, defined as Seattle angina questionnaire (SAQ) Summary Score ≤ 70, and MACE, defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization (any cause) and target vessel revascularization at 1 year follow-up.
at 1-year follow-up
Secondary Outcomes (6)
Rate of patients with significant angina (SAQ Angina Summary Score ≤ 70)
at 1-year follow-up
Incidence of MACE
at 1-year follow-up
Rate of cardiac death
at 1-year follow-up
Rate of MI
at 1-year follow-up
Rate of cardiac hospitalization
at 1-year follow-up
- +1 more secondary outcomes
Study Arms (2)
"full-physiology approach" arm
EXPERIMENTALIn the "full-physiology approach" arm, patients will be, during CA, simultaneously subjected to a full interventional diagnostic procedure, including: * resting distal coronary pressure to aortic pressure ratio (Pd/Pa); * fractional flow reserve (FFR) after intravenous adenosine administration; * Resting Ful-Cycle Ratio (RFR); * coronary flow reserve (CFR) and index of microvascular resistance (IMR); * assessment of FFR, CFR and IMR after inotropic stimulation with dobutamine (respectively FFR-d, CFR-d and IMR-d); * acetylcholine (ACH) provocative test.
"standard approach" arm
OTHERIn the "standard approach" arm, patients will undergo only an angiographic evaluation, without any invasive intracoronary assessment.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 28100, 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
Related Publications (5)
D'Amario D, Ciliberti G, Restivo A, Laborante R, Migliaro S, Canonico F, Sangiorgi GM, Tebaldi M, Porto I, Andreini D, Vergallo R, Leone AM, Gervasi S, Cammarano M, Palmieri V, Burzotta F, Trani C, Zeppilli P, Crea F; RIALTO Registry Investigators. Myocardial bridge evaluation towards personalized medicine: study design and preliminary results of the RIALTO registry. Eur Heart J Suppl. 2022 Nov 11;24(Suppl H):H48-H56. doi: 10.1093/eurheartjsupp/suac059. eCollection 2022 Nov.
PMID: 36382004BACKGROUNDCiliberti G, Laborante R, Di Francesco M, Restivo A, Rizzo G, Galli M, Canonico F, Zito A, Princi G, Vergallo R, Leone AM, Burzotta F, Trani C, Palmieri V, Zeppilli P, Crea F, D'Amario D. Comprehensive functional and anatomic assessment of myocardial bridging: Unlocking the Gordian Knot. Front Cardiovasc Med. 2022 Nov 8;9:970422. doi: 10.3389/fcvm.2022.970422. eCollection 2022.
PMID: 36426224BACKGROUNDCappannoli L, Ciliberti G, Restivo A, Palumbo P, D'Alo F, Sanna T, Crea F, D'Amario D. 'Here comes the story of the Hurricane': a case report of AL cardiac amyloidosis and myocardial bridging. Eur Heart J Case Rep. 2022 May 31;6(7):ytac225. doi: 10.1093/ehjcr/ytac225. eCollection 2022 Jul.
PMID: 35854894BACKGROUNDMontone RA, Gurgoglione FL, Del Buono MG, Rinaldi R, Meucci MC, Iannaccone G, La Vecchia G, Camilli M, D'Amario D, Leone AM, Vergallo R, Aurigemma C, Buffon A, Romagnoli E, Burzotta F, Trani C, Crea F, Niccoli G. Interplay Between Myocardial Bridging and Coronary Spasm in Patients With Myocardial Ischemia and Non-Obstructive Coronary Arteries: Pathogenic and Prognostic Implications. J Am Heart Assoc. 2021 Jul 20;10(14):e020535. doi: 10.1161/JAHA.120.020535. Epub 2021 Jul 14.
PMID: 34259010BACKGROUNDD'Amario D, Cammarano M, Quarta R, Casamassima F, Restivo A, Bianco M, Palmieri V, Zeppilli P. 'A bridge over troubled water': a case report. Eur Heart J Case Rep. 2021 Mar 31;5(3):ytab109. doi: 10.1093/ehjcr/ytab109. eCollection 2021 Mar.
PMID: 33824938BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giuseppe Patti, Prof
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
February 15, 2024
First Posted
February 28, 2024
Study Start
December 15, 2023
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share