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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocarditis Acute; Inflammatory Cardiomyopathy
• Intervention / Treatment: Other: characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Domingo Pascual Figal, MD; Phone Number: 868885273; Email: coordinacion@premyo.org

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • HCUVA
    • Contact: Domingo Pascual Figal, MD; Phone Number: 868885273; Email: coordinacion@premyo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients with clinical suspicion of myocarditis or inflammatory cardiomyopathy will be included, based on the presence of compatible clinical findings.

Description

Inclusion Criteria:

• Presence of at least one compatible symptom and at least one objective finding in diagnostic tests (Figure 2), according to the consensus document of the European Society of Cardiology (1):

A. Clinical presentation:

• Acute chest pain: pericardial or pseudo-ischemic.
• Dyspnea on exertion or at rest for up to 3 months.
• Dyspnea on exertion or at rest for 3 months - 1 year.
• Unexplained palpitations / arrhythmias, sudden death recovered.
• Unexplained cardiogenic shock.

B. Findings in complementary tests:

• ECG: new onset AV block, new onset bundle branch block, ST segment elevation/depression, T wave inversion
• Elevation of TnI/TnT
• Segmental or global contractility alterations not explained by other causes
• Positive Lake Louise criteria in cardiac MRI (13) (Annex III Figure S1) • Patients who have given their informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.	Subjects will be recruited during an emergency room visit or within their usual clinical practice among those patients who meet the criteria for participation in the study.	Up to 3 years

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Investigators: Principal Investigator: Domingo Pascual Figal, MD, HCUVA

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Myocarditis; Cardiomyopathies
• Other Study ID Numbers: 2023-5-2-HCUVA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No