Status:
RECRUITING
GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.
Lead Sponsor:
Scientific Institute San Raffaele
Conditions:
Myocarditis
Ventricular Arrythmia
Eligibility:
All Genders
10-80 years
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...
Detailed Description
Arrhythmic myocarditis is responsible for a significant proportion of out-of-hospital cardiac arrest and death in the young population. Although considered an uncommon feature, arrhythmias may present...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT06889662
Start Date
February 25 2025
End Date
December 1 2027
Last Update
March 21 2025
Active Locations (1)
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1
Scientific Institute San Raffaele
Milan, Italy/Milan, Italy, 20132