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

Recruiting now

Conditions studied: Myocarditis, Ventricular Arrythmia

In brief

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.

Key facts

Study ID

NCT06889662

Run by

Scientific Institute San Raffaele

People needed

262

Starts

2025-02-25

Expected to finish

2027-12-01

Last updated by the study team

2025-03-21

Who can join

Age: 10 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Scientific Institute San Raffaele — Milan, Italy/Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.