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RECRUITINGOBSERVATIONAL

GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.

GEAM: Yield of GEnetic Testing in Arrhythmic Myocarditis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study aims to answer multiple unsolved questions in the field of arrhythmic myocarditis. * Improving the diagnostic work-up. While endomyocardial biopsy (EMB) and cardiac magnetic resonance (CMR) constitute the gold standard diagnostic techniques for myocarditis, the role of genetic testing is still unclear. Identifying the subset of patients with CGVs, will contribute to justifying the application of genetic testing in myocarditis. * Generating models for risk prediction. Outcomes and arrhythmic risk stratification remain uncertain for myocarditis. Based on an advanced multimodal work-up, multiparametric risk scores may be created and subsequently validated, in order to predict the arrhythmic risk of specific myocarditis, especially in the case of CGVs. * Identifying disease-specific and genotype-specific signatures. Genotype-phenotype associations are expected to benefit from a multimodal and multiparametric approach, in order to allow etiology-specific features in arrhythmic myocarditis. Most of the current signatures are limited to combined EMB-CMR studies. Signatures would likely benefit from implementing additional parameters, including arrhythmia features and myocardial inflammatory status. * Tailoring treatment strategies. Transcriptional analysis will identify overexpressed genes associated with myocarditis and arrhythmias, representing a possible therapeutic target. A multimodal and multidisciplinary model will integrate phenotype, genotype, and transcriptional profile for a personalized treatment.

Who May Be Eligible (Plain English)

Who May Qualify: Patients with ventricular arrhythmias (VA+) and without (VA-) - Diagnosis of myocarditis proven by EMB (ESC criteria) and/or CMR (updated Lake Louise criteria) - Age ≥ 10 years - Baseline ECG telemonitoring - Written willing to sign a consent form Healthy controls - Provided a negative known history of myocarditis - The sample must have been biobanked as part of the study IMMUNORADAR Who Should NOT Join This Trial: Patients with ventricular arrhythmias (VA+) and without (VA-) - Obstructive coronary artery disease, or lack of coronary angiography/computed tomography (CT) scan in patients \>40 years. - Absent willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Patients with ventricular arrhythmias (VA+) and without (VA-) * Diagnosis of myocarditis proven by EMB (ESC criteria) and/or CMR (updated Lake Louise criteria) * Age ≥ 10 years * Baseline ECG telemonitoring * Written informed consent Healthy controls * Provided a negative known history of myocarditis * The sample must have been biobanked as part of the study IMMUNORADAR Exclusion Criteria: Patients with ventricular arrhythmias (VA+) and without (VA-) * Obstructive coronary artery disease, or lack of coronary angiography/computed tomography (CT) scan in patients \>40 years. * Absent informed consent.

Locations (1)

Scientific Institute San Raffaele
Milan, Italy/Milan, Italy