Phase
Condition
N/ATreatment
"full-physiology approach" arm
"standard approach" arm
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 theterritory 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
Exclusion Criteria:
Moderate to severe CAD (≥ 50% stenosis in any vessel, including chronic totalocclusion) 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 ofthe 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 portalhypertension.
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 coronaryphysiology testing (nitrates, adenosine, dobutamine, acetylcholine).
Study Design
Study Description
Connect with a study center
Ospedale Generale Regionale F. Miulli
Acquaviva Delle Fonti,
ItalySite Not Available
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria,
ItalySite Not Available
Ospedale San Donato
Arezzo,
ItalySite Not Available
ASST Papa Giovanni XXIII
Bergamo,
ItalySite Not Available
Ospedale degli Infermi di Biella
Biella,
ItalySite Not Available
Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria
Bologna,
ItalySite Not Available
Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano
Caserta,
ItalySite Not Available
Villa Maria Cecilia Hospital
Cotignola,
ItalySite Not Available
Azienda Ospedaliero Universitaria di Ferrara
Ferrara,
ItalySite Not Available
Azienda Ospedaliero Universitaria Careggi
Firenze,
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico San Martino
Genova,
ItalySite Not Available
Ospedale Della Misericordia
Grosseto,
ItalySite Not Available
Centro Cardiologico Monzino IRCCS
Milano,
ItalySite Not Available
IRCCS Ospedale Galeazzi
Milano,
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza,
ItalySite Not Available
AOU Maggiore della Carità
Novara, 28100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria di Parma
Parma,
ItalySite Not Available
Azienda Ospedaliera di Perugia
Perugia,
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa,
ItalySite Not Available
Ospedale San Jacopo
Pistoia,
ItalySite Not Available
Ospedali Riuniti di Rivoli
Rivoli,
ItalySite Not Available
Aurelia Hospital
Roma,
ItalySite Not Available
Azienda Ospedaliera San Camillo-Forlanini
Roma,
ItalySite Not Available
Azienda Ospedaliero Universitaria Sant'Andrea
Roma,
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma,
ItalyActive - Recruiting
Ospedale Sandro Pertini
Roma,
ItalySite Not Available
Ospedale Santo Spirito
Roma,
ItalySite Not Available
Policlinico Universitario Tor Vergata Fondazione PTV
Roma,
ItalySite Not Available
Ospedale Civile Santissima Annunziata
Sassari,
ItalySite Not Available
Azienda Sanitaria Provinciale di Siracusa
Siracusa,
ItalySite Not Available
Azienda Ospedaliera Ordine Mauriziano
Torino,
ItalySite Not Available
Azienda Ospedaliero Universitaria Città Della Salute E Scienza
Torino,
ItalySite Not Available
Presidio Ospedaliero Sant'Andrea
Vercelli,
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata, Ospedale Borgo Trento
Verona,
ItalySite Not Available
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