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

NCT06898762 | Recruiting

• 1 other identifier: 2023-5-2-HCUVA
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocarditis Acute; Inflammatory Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

HCUVA

Murcia, Murcia, 30120, Spain

RECRUITING

Study Officials

• Domingo Pascual Figal, MD

  HCUVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domingo Pascual Figal, MD

CONTACT

868885273; coordinacion@premyo.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: April 9, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

ES (1)