National platform for studying inflammatory heart disease
Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort
This study is trying to gather information from patients with suspected heart inflammation to better understand their symptoms, treatment, and the factors that affect their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia Academic / other |
| Locations | 1 site (Murcia, Murcia) |
| Trial ID | NCT06898762 on ClinicalTrials.gov |
What this trial studies
This project aims to create a comprehensive national cohort of patients with suspected myocarditis and inflammatory cardiomyopathy. It will characterize their clinical features, management, and biomarkers, while also validating a new diagnostic biomarker against conventional methods. The study will explore genetic mutations and environmental factors that may influence the severity and treatment response of myocarditis, as well as the observed differences in incidence between genders and across age groups.
Who should consider this trial
Good fit: Ideal candidates include individuals presenting symptoms compatible with myocarditis, such as acute chest pain, dyspnea, or unexplained arrhythmias, along with objective findings from diagnostic tests.
Not a fit: Patients without symptoms or objective findings indicative of myocarditis or inflammatory cardiomyopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and personalized treatment strategies for patients with myocarditis.
How similar studies have performed: While there have been studies on myocarditis, this approach of creating a national multicenter platform for comprehensive characterization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Murcia, Murcia
- Hcuva — Murcia, Murcia, Spain (Recruiting)
Study contacts
- Principal investigator: Domingo Pascual Figal, MD — Hcuva
- Study coordinator: Domingo Pascual Figal, MD
- Email: coordinacion@premyo.org
- Phone: 868885273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.