Precision medicine versus standard of care for patients with myocardial infarction with non-obstructive coronary arteries (MINOCA): rationale and design of the multicentre, randomised PROMISE trial

DOI: 10.4244/EIJ-D-22-00178

Rocco Montone
Rocco Antonio Montone1, MD, PhD; Nicola Cosentino2, MD; Francesca Graziani1, MD, PhD; Riccardo Gorla3, MD; Marco Giuseppe Del Buono4, MD; Giulia La Vecchia4, MD; Riccardo Rinaldi4, MD; Giancarlo Marenzi2, MD; Antonio L. Bartorelli2, MD; Federico De Marco3, MD, PhD; Luca Testa3, MD, PhD; Francesco Bedogni3, MD; Carlo Trani1,4, MD; Giovanna Liuzzo1,4, MD, PhD; Giampaolo Niccoli5, MD, PhD; Filippo Crea1,4, MD, PhD
1. Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 2. Centro Cardiologico Monzino, IRCCS, Milan, Italy; 3. Cardiology Unit, IRCCS Policlinico San Donato, Milan, Italy; 4. Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart, Rome, Italy; 5. Department of Medicine, University of Parma, Parma, Italy

Myocardial infarction with non-obstructive coronary arteries (MINOCA) represents about 6-8% of patients presenting with myocardial infarction (MI), and it is associated with a significant risk of mortality, rehospitalisation, and angina burden, with high associated socioeconomic costs. It is important to note that multiple mechanisms may be responsible for MINOCA. However, to date, there are few prospective clinical trials on MINOCA and the treatment of these patients is still not defined, most likely because of the multiple underlying pathogenic mechanisms. The PROMISE trial is a randomised, multicentre, prospective, superiority, phase IV trial that will include 180 MINOCA patients randomised 1:1 to a "precision-medicine approach", consisting of a comprehensive diagnostic workup and pharmacological treatment specific for the underlying cause, versus a "standard of care” approach, consisting of routine diagnostic workup and standard medical treatment for acute coronary syndrome. The aim of this study is to evaluate if the “precision-medicine approach” will improve the angina status, evaluated using the Seattle Angina Questionnaire summary score, at 12 months (primary endpoint). Secondary endpoints include the rate of major adverse cardiovascular events at 12-month follow-up, the related primary and secondary healthcare costs, and the ability of cardiac magnetic resonance to evaluate the different mechanisms of MINOCA. Of importance, the results derived from this trial may pave the way for a new pathophysiology-driven approach with cause-target therapies personalised for the mechanisms of MINOCA (ClinicalTrials.gov: NCT05122780).

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