Actively Recruiting
Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
Led by Azienda Ospedaliero Universitaria Maggiore della Carita · Updated on 2024-07-10
500
Participants Needed
34
Research Sites
106 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero Universitaria Maggiore della Carita
Lead Sponsor
U
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to give informed consent to the study.
- Age 18 years or older and 75 years or younger.
- Diagnosis of myocardial bridge during coronary angiography.
- Presence of symptoms or signs of inducible ischemia involving the affected vessel territory.
You will not qualify if you...
- Moderate to severe coronary artery disease with 50% or greater stenosis in any vessel.
- Previous coronary artery bypass graft involving the affected vessel.
- Severe valvular heart disease.
- Left ventricular ejection fraction less than 40%.
- Clinically significant right ventricular dysfunction.
- Severe renal impairment (eGFR less than 30 ml/min/1.73 m2).
- Severe hepatic impairment or history of cirrhosis with portal hypertension.
- History of malignancy with life expectancy less than 1 year.
- Previous ischemic stroke, intracranial hemorrhage, or related brain disease.
- Pregnant or breastfeeding women.
- Known allergy or contraindication to drugs used in coronary physiology testing (nitrates, adenosine, dobutamine, acetylcholine).
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Trial Site Locations
Total: 34 locations
1
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Italy
Not Yet Recruiting
2
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Not Yet Recruiting
3
Ospedale San Donato
Arezzo, Italy
Not Yet Recruiting
4
ASST Papa Giovanni XXIII
Bergamo, Italy
Not Yet Recruiting
5
Ospedale degli Infermi di Biella
Biella, Italy
Not Yet Recruiting
6
Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria
Bologna, Italy
Not Yet Recruiting
7
Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano
Caserta, Italy
Not Yet Recruiting
8
Villa Maria Cecilia Hospital
Cotignola, Italy
Not Yet Recruiting
9
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy
Not Yet Recruiting
10
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Not Yet Recruiting
11
Azienda Ospedaliera Universitaria Policlinico San Martino
Genova, Italy
Not Yet Recruiting
12
Ospedale Della Misericordia
Grosseto, Italy
Not Yet Recruiting
13
Centro Cardiologico Monzino IRCCS
Milan, Italy
Not Yet Recruiting
14
IRCCS Ospedale Galeazzi
Milan, Italy
Not Yet Recruiting
15
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Not Yet Recruiting
16
AOU Maggiore della Carità
Novara, Italy, 28100
Actively Recruiting
17
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Not Yet Recruiting
18
Azienda Ospedaliera di Perugia
Perugia, Italy
Not Yet Recruiting
19
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Not Yet Recruiting
20
Ospedale San Jacopo
Pistoia, Italy
Not Yet Recruiting
21
Ospedali Riuniti di Rivoli
Rivoli, Italy
Not Yet Recruiting
22
Aurelia Hospital
Roma, Italy
Not Yet Recruiting
23
Azienda Ospedaliera San Camillo-Forlanini
Roma, Italy
Not Yet Recruiting
24
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, Italy
Not Yet Recruiting
25
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
26
Ospedale Sandro Pertini
Roma, Italy
Not Yet Recruiting
27
Ospedale Santo Spirito
Roma, Italy
Not Yet Recruiting
28
Policlinico Universitario Tor Vergata Fondazione PTV
Roma, Italy
Not Yet Recruiting
29
Ospedale Civile Santissima Annunziata
Sassari, Italy
Not Yet Recruiting
30
Azienda Sanitaria Provinciale di Siracusa
Syracuse, Italy
Not Yet Recruiting
31
Azienda Ospedaliera Ordine Mauriziano
Torino, Italy
Not Yet Recruiting
32
Azienda Ospedaliero Universitaria Città Della Salute E Scienza
Torino, Italy
Not Yet Recruiting
33
Presidio Ospedaliero Sant'Andrea
Vercelli, Italy
Not Yet Recruiting
34
Azienda Ospedaliera Universitaria Integrata, Ospedale Borgo Trento
Verona, Italy
Not Yet Recruiting
Research Team
D
Domenico D'Amario, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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