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NCT Number: NCT06898762

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HCUVA

Murcia, 30120, Spain

Location status: Recruiting

Location contact

Domingo Pascual Figal, MD

CONTACT

[email protected]

868885273

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Up to 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Domingo Pascual Figal, MD

CONTACT

[email protected]

868885273

Sponsors and collaborators

Lead sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Other

Registry information

Acronym: PREMYO

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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