GEAM: Yield of GEnetic Testing in Arrhythmic Myocarditis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 80
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Italy
Scientific Institute San Raffaele
RECRUITING
Milan
Contact Information
Primary
Giovanni Peretto, Medical Doctor, PhD
peretto.giovanni@gmail.com
39+ 0226437340
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 262
Treatments
VA+
with ventricular arrhythmias
VA-
without ventricular arrhythmias
Related Therapeutic Areas
Sponsors
Leads: Scientific Institute San Raffaele

This content was sourced from clinicaltrials.gov

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