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

Recruitingn/aAges 18 Years - anyAllFundacion para la Formacion e Investigacion Sanit…
NCT06898762 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

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

1 site
HCUVA
Murcia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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