Rocco Antonio Montone, Nicola Cosentino, Francesca Graziani, Riccardo Gorla, Marco Giuseppe Del Buono, Giulia La Vecchia, Riccardo Rinaldi, Giancarlo Marenzi, Antonio L Bartorelli, Federico De Marco, Luca Testa, Francesco Bedogni, Carlo Trani, Giovanna Liuzzo, Giampaolo Niccoli, Filippo Crea. 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. EuroIntervention. 2022 Dec 2;18(11):e933-e939. doi: 10.4244/EIJ-D-22-00178. PMID: 35734824.
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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Authors: Rocco Antonio Montone, Nicola Cosentino, Francesca Graziani, Riccardo Gorla, Marco Giuseppe Del Buono, Giulia La Vecchia, Riccardo Rinaldi, Giancarlo Marenzi, Antonio L Bartorelli, Federico De Marco, Luca Testa, Francesco Bedogni, Carlo Trani, Giovanna Liuzzo, Giampaolo Niccoli, Filippo Crea
Date published: December 2nd, 2022
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