RecruitingNCT06898762

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


Sponsor

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

Enrollment

3,000 participants

Start Date

Apr 9, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • • 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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Interventions

OTHERcharacterization 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.


Locations(1)

HCUVA

Murcia, Murcia, Spain

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NCT06898762


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