Rationale and design of the Pre-MYO project: a precision-medicine platform for myocarditis diagnosis and management

Abstract

INTRODUCTION: Myocarditis is an inflammatory disease characterized by a wide spectrum of clinical presentations, which complicates its diagnosis and management. The Precision Biomarkers for Diagnosis and Management of Myocardial Inflammatory Diseases (Pre-MYO) project aims to address three major gaps: (i) the limited knowledge regarding the epidemiology, clinical management and prognosis; (ii) the absence of specific and widely accessible biomarkers able to provide an early diagnosis (precision medicine); (iii) the lack of biomarkers of susceptibility to myocarditis, including risk of recurrence and disease severity (personalized medicine). STUDY DESIGN: The Pre-MYO is a prospective, observational and multicentre nationwide project designed to enrol 3000 patients with suspected myocarditis or inflammatory cardiomyopathy based on clinical findings. The registry includes extensive clinical characterization and long-term follow-up, including biobanks of blood samples, DNA, and cardiac magnetic resonance imaging (CMR). The platform will enable the investigation and validation of novel diagnostic and prognostic biomarkers, including the candidate hsa-RNA-Chr8:96, and the development of clinical trials. Predisposition studies will be conducted to investigate environmental and immune factors, genetic mutations, and acquired variants-including methylation analyses-that contribute to individual predisposition and risk. DISCUSSION: The Pre-MYO project will establish a collaborative research framework aimed at improving the understanding and clinical management of myocarditis by integrating precision and personalized medicine approaches.