Actively Recruiting

Age: 10Years - 80Years
All Genders
Healthy Volunteers
NCT06889662

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

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

262

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 diagnosed with myocarditis confirmed by endomyocardial biopsy (ESC criteria) and/or cardiac magnetic resonance (updated Lake Louise criteria)
  • Patients with or without ventricular arrhythmias
  • Age 10 years or older
  • Baseline ECG telemonitoring performed
  • Provided written informed consent
  • Healthy controls with no known history of myocarditis
  • Biobanked samples as part of the IMMUNORADAR study
Not Eligible

You will not qualify if you...

  • Presence of obstructive coronary artery disease, or lack of coronary angiography/computed tomography scan in patients over 40 years
  • Absence of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Scientific Institute San Raffaele

Milan, Italy/Milan, Italy, 20132

Actively Recruiting

Loading map...

Research Team

G

Giovanni Peretto, Medical Doctor, PhD

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here