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GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.

Launched by SCIENTIFIC INSTITUTE SAN RAFFAELE · Mar 19, 2025

Trial Information

Current as of April 22, 2025

Recruiting

Keywords

Arrhythmogenic Cardiomyopathy Ventricular Arrhythmias Myocardial Inflammation

ClinConnect Summary

The GEAM Study is a clinical trial that aims to explore how genetic testing can help in understanding and treating arrhythmic myocarditis, a condition where inflammation of the heart muscle leads to irregular heartbeats. Researchers want to find out if genetic testing can improve diagnosis, predict risks of heart problems, and help create personalized treatment plans for patients with this condition. This study will look at both patients with ventricular arrhythmias (irregular heartbeats) and those without, focusing on how different genetic factors may influence the disease and its symptoms.

To be eligible for the trial, participants should be at least 10 years old and have a confirmed diagnosis of myocarditis through specific heart tests. They will undergo a thorough evaluation, including monitoring their heart activity. Healthy volunteers without a history of myocarditis can also participate. Throughout the study, participants can expect to contribute to important research that may lead to better treatments for myocarditis and its related complications.

Gender

ALL

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.

Trial Officials

Paolo Della Bella, MD

Study Chair

Scientific Institute San Raffaele, Milan, Italy

About Scientific Institute San Raffaele

The Scientific Institute San Raffaele is a leading research and clinical care institution based in Milan, Italy, dedicated to advancing healthcare through innovative scientific research and high-quality patient care. With a strong emphasis on translational medicine, the institute integrates cutting-edge research with clinical applications, fostering collaboration among scientists, clinicians, and industry partners. San Raffaele is committed to enhancing the understanding of complex diseases and developing novel therapeutic strategies, thereby contributing to the improvement of global health outcomes. Its state-of-the-art facilities and multidisciplinary approach position the institute as a key player in the landscape of clinical trials and biomedical research.

Locations

Milan, Italy/Milan, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported