NCT06889662 GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.
| NCT ID | NCT06889662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Scientific Institute San Raffaele |
| Condition | Myocarditis |
| Study Type | OBSERVATIONAL |
| Enrollment | 262 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 262 participants in total. It began in 2025-02-25 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Paolo Della Bella, MD
STUDY CHAIR
Scientific Institute San Raffaele, Milan, Italy
Frequently Asked Questions
Who can join the NCT06889662 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 80 Years, studying Myocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06889662 currently recruiting?
Yes, NCT06889662 is actively recruiting participants. Contact the research team at peretto.giovanni@gmail.com for enrollment information.
Where is the NCT06889662 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06889662 clinical trial?
NCT06889662 is sponsored by Scientific Institute San Raffaele. The principal investigator is Paolo Della Bella, MD at Scientific Institute San Raffaele, Milan, Italy. The trial plans to enroll 262 participants.