Actively Recruiting
GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.
Led by Scientific Institute San Raffaele · Updated on 2025-03-21
262
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with myocarditis confirmed by endomyocardial biopsy (ESC criteria) and/or cardiac magnetic resonance (updated Lake Louise criteria)
- Patients with or without ventricular arrhythmias
- Age 10 years or older
- Baseline ECG telemonitoring performed
- Provided written informed consent
- Healthy controls with no known history of myocarditis
- Biobanked samples as part of the IMMUNORADAR study
You will not qualify if you...
- Presence of obstructive coronary artery disease, or lack of coronary angiography/computed tomography scan in patients over 40 years
- Absence of informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Scientific Institute San Raffaele
Milan, Italy/Milan, Italy, 20132
Actively Recruiting
Research Team
G
Giovanni Peretto, Medical Doctor, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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