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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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