An observational study in Myocarditis Acute and Inflammatory Cardiomyopathy, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Observational
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.
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.
174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 208 across 120 observational studies indexed under Myocarditis.
Browse Myocarditis studies →Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 43 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with clinical suspicion of myocarditis or inflammatory cardiomyopathy will be included, based on the presence of compatible clinical findings.
Inclusion Criteria:
A. Clinical presentation:
B. Findings in complementary tests:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
characterization 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.
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.
Time frame: Up to 3 years
Started Apr 2023 (actual). Primary completion is estimated for Dec 2028, 68 months after the start.
Of 70 non-industry observational studies under Myocarditis, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 251. This study's planned 68 months is close to that.
Counting every sponsor, half of 71 studies reached it within 69 months; a quarter within 20 and three quarters within 251.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia