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Taking people in ItalyNo phase

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

Key facts

Who runs it
Scientific Institute San Raffaele
Where
Milan, ItalySee the site
Trial code
Status
Recruiting
People taking part
262 people, planned
Started
25 Feb 2025
Expected to end
1 Dec 2027
Type of study
Observational, 2 groups
Record updated
21 March 2025

Who can take part

Age
10 years to 80 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 80 years old?

Where in Italy

  • Scientific Institute San RaffaeleMilan, ItalyContact: Giovanni Peretto, Medical Doctor, PhDTaking people

About the trial

What the trial wants to find out

This study aims to answer multiple unsolved questions in the field of arrhythmic myocarditis.

Read full original descriptionShow less

* 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.

The 2 groups in the trial

  • VA+

    with ventricular arrhythmias

  • VA-

    without ventricular arrhythmias

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
GEAM: Yield of GEnetic Testing in Arrhythmic Myocarditis
Fit questions
Built from NCT06889662, who can take part
Record updated
21 March 2025