Actively Recruiting

Age: 10Years - 80Years
All Genders
Healthy Volunteers
ID06889662

GEAM: Yield of Genetic Testing in Arrhythmic Myocarditis

Led by Scientific Institute San Raffaele · Updated on 2025-03-21

262

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating arrhythmic myocarditis, a heart condition that can cause dangerous irregular heartbeats and sudden cardiac death, especially in young people. This study focuses on understanding the role of genetic testing alongside current diagnostic methods like heart biopsy and MRI. The goal is to improve diagnosis, predict risks, identify specific disease patterns linked to genetics, and develop personalized treatment strategies by combining genetic, clinical, and inflammatory information. Participants include those with and without ventricular arrhythmias, confirmed by biopsy or MRI, who are at least 10 years old. The study collects detailed genetic, clinical, and heart function data at baseline and during follow-up visits. Genetic screening will be compared between patient groups and healthy controls to find gene variants related to myocarditis. The study also explores gene activity in heart tissue to identify targets for therapy and aims to create risk models based on multiple patient factors. During the study, participants undergo heart monitoring including ECG telemonitoring, clinical assessments, and genetic testing. Researchers will track arrhythmia patterns at the start and after 12 months and analyze how genetics influence disease progression. Healthy controls without myocarditis also provide samples for comparison. The study includes follow-up evaluations to better understand arrhythmic risk and disease mechanisms over time, lasting until 2027.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with ventricular arrhythmias (VA+) and without (VA-)
  • Diagnosis of myocarditis proven by endomyocardial biopsy (ESC criteria) and/or cardiac magnetic resonance imaging (updated Lake Louise criteria)
  • Age 10 years or older
  • Baseline ECG telemonitoring
  • Written informed consent
  • Healthy controls must have no known history of myocarditis
  • Healthy control samples must be biobanked as part of the IMMUNORADAR study
Not Eligible

You will not qualify if you...

  • Obstructive coronary artery disease, or lack of coronary angiography or CT scan in patients over 40 years old
  • Absence of informed consent

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 6 months

Participants undergo diagnostic tests including endomyocardial biopsy and cardiac magnetic resonance imaging to confirm myocarditis and to characterize ventricular arrhythmias.

Multiple visits depending on diagnostic procedures

Long-term Monitoring

Duration - 12 months

Participants are monitored over time to characterize ventricular arrhythmias and to screen for cardiomyopathic gene variants.

Follow-up visits over 12 months

Trial Site Locations

Total: 1 location

1

Scientific Institute San Raffaele

Milan, Italy/Milan, Italy, 20132

Actively Recruiting

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Research Team

G

Giovanni Peretto, Medical Doctor, PhD

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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Published Research Related To This Trial

Chromatin Velocity reveals epigenetic dynamics by single-cell profiling of heterochromatin and euchromatin.

Martina Tedesco, Francesca Giannese, Dejan Lazarević...

https://pubmed.ncbi.nlm.nih.gov/34635836

Inflammation on Endomyocardial Biopsy Predicts Risk of MACE in Undefined Left Ventricular Arrhythmogenic Cardiomyopathy.

Giovanni Peretto, Michela Casella, Marco Merlo...

https://pubmed.ncbi.nlm.nih.gov/36752457

Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology.

Sue Richards, Nazneen Aziz, Sherri Bale...

https://pubmed.ncbi.nlm.nih.gov/25741868

Multimodal Detection and Targeting of Biopsy-Proven Myocardial Inflammation in Genetic Cardiomyopathies: A Pilot Report.

Giovanni Peretto, Giacomo De Luca, Andrea Villatore...

https://pubmed.ncbi.nlm.nih.gov/37547072

Immunosuppressive Therapy and Risk Stratification of Patients With Myocarditis Presenting With Ventricular Arrhythmias.

Giovanni Peretto, Simone Sala, Giacomo De Luca...

https://pubmed.ncbi.nlm.nih.gov/33092747

Intercalated disc abnormalities, reduced Na(+) current density, and conduction slowing in desmoglein-2 mutant mice prior to cardiomyopathic changes.

Stefania Rizzo, Elisabeth M Lodder, Arie O Verkerk...

https://pubmed.ncbi.nlm.nih.gov/22764152