NCT06898762 Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort
| NCT ID | NCT06898762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Condition | Myocarditis Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-04-09 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-04-09 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Domingo Pascual Figal, MD
PRINCIPAL INVESTIGATOR
HCUVA
Frequently Asked Questions
Who can join the NCT06898762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocarditis Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06898762 currently recruiting?
Yes, NCT06898762 is actively recruiting participants. Contact the research team at coordinacion@premyo.org for enrollment information.
Where is the NCT06898762 trial being conducted?
This trial is being conducted at Murcia, Spain.
Who is sponsoring the NCT06898762 clinical trial?
NCT06898762 is sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. The principal investigator is Domingo Pascual Figal, MD at HCUVA. The trial plans to enroll 3,000 participants.