NCT06898762

Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this project are: 1) to comprehensively characterize a large national cohort of patients with suspected myocarditis, their clinical phenotype, care management, blood and imaging biomarkers, epidemiological, environmental and genetic data; 2) to retrospectively validate the accuracy of the new hsa-RNA-Chr8:96 biomarker for the diagnosis of myocarditis compared to conventional diagnosis; 3) to identify acquired and inherited mutations, and their interaction with the environment, which explain the susceptibility to myocarditis, its severity and response to treatment; 4) to study the lower incidence in women and the influence of age, considering socio-health and genetic factors.

Detailed description

The primary endpoint of the study will be the characterization of a broad national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy. The secondary endpoints of the study will be (A) individual susceptibility to developing myocarditis or inflammatory cardiomyopathy, 1) identifying acquired and inherited genetic variants, and 2) from the persistence of gender, age, and socioenvironmental conditions; and (B) studying the correlation between the final diagnosis of myocarditis and the hsa-miR-Chr8:96 marker.

Conditions

• Myocarditis Acute
• Inflammatory Cardiomyopathy

Interventions

Type	Name	Description
OTHER	characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.	characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.

Timeline

• Start date: 2023-04-09
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-03-27
• Last updated: 2025-03-27

Locations

1 site across 1 country: Spain