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

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• To provide baseline characterization of VA in the study cohort. — Baseline
  Prevalence of baseline VA
• To provide baseline characterization of VA in the study cohort. — baseline
  Type of VA
• To provide baseline characterization of VA in the study cohort. — baseline
  Morphology of VA
• To provide follow-up characterization of VA in study cohort. — 12 months
  Occurrence of VA by 12 months
• To provide follow-up characterization of VA in study cohort. — 12 months
  Burden of VA (number of VA events per month)
• To screen for CGVs in study groups — 6 months
  Prevalence of CGVs in myocarditis with VA (VA+) vs. without VA (VA-)
• To screen for CGVs in study groups vs healthy controls — 6 months
  Prevalence of CGVs in myocarditis with VA (VA+) and without VA (VA-) vs. healthy controls
• To investigate the pathophysiological basis of arrhythmic myocarditis in study group (exploratory endpoint) — during the procedure
  Comparison of gene expression profile on EMB in inflammatory group vs no inflammatory group

Trial sites (1)

More Scientific Institute San Raffaele trials in Italy

Other trials for the same condition