Assessing genetic testing's role in arrhythmic myocarditis
GEAM: Yield of GEnetic Testing in Arrhythmic Myocarditis
Scientific Institute San Raffaele · NCT06889662
This study is testing how genetic testing can help people with myocarditis and heart rhythm problems by finding specific gene changes that might affect their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 262 (estimated) |
| Ages | 10 Years to 80 Years |
| Sex | All |
| Sponsor | Scientific Institute San Raffaele (other) |
| Locations | 1 site (Milan, Italy/Milan) |
| Trial ID | NCT06889662 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of genetic testing in patients diagnosed with myocarditis and ventricular arrhythmias. It seeks to improve diagnostic processes by identifying patients with cardiomyopathic gene variants (CGVs) and to develop risk prediction models for arrhythmic events. The study will also investigate genotype-phenotype associations to uncover disease-specific signatures that could enhance understanding of arrhythmic myocarditis. By utilizing advanced diagnostic techniques, the study hopes to clarify the implications of genetic factors in this condition.
Who should consider this trial
Good fit: Ideal candidates include patients aged 10 years and older diagnosed with myocarditis and experiencing ventricular arrhythmias.
Not a fit: Patients with obstructive coronary artery disease or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and risk stratification for patients with arrhythmic myocarditis.
How similar studies have performed: While the role of genetic testing in myocarditis is still being explored, previous studies have indicated potential benefits in understanding genetic contributions to arrhythmias.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, Italy/Milan
- Scientific Institute San Raffaele — Milan, Italy/Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Giovanni Peretto, Medical Doctor, PhD
- Email: peretto.giovanni@gmail.com
- Phone: 39+ 0226437340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocarditis, Ventricular Arrythmia, Arrhythmogenic cardiomyopathy, Ventricular arrhythmias, Myocardial inflammation