An observational study in Myocarditis and Ventricular Arrythmia, sponsored by Scientific Institute San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 10 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Scientific Institute San Raffaele · Observational
This study aims to answer multiple unsolved questions in the field of arrhythmic myocarditis.
Arrhythmic myocarditis is responsible for a significant proportion of out-of-hospital cardiac arrest and death in the young population. Although considered an uncommon feature, arrhythmias may present in myocarditis in both acute and chronic phase, leading to sudden cardiac death (SCD), especially in young males. Overall, the prevalence of undiagnosed myocarditis in post-mortem series ranges from 9% to 44%, involving 2% of infants, 5% of children, and 4-8% of athletes \<40-year-old. Ventricular arrhythmias (VAs) are reported secondary to lymphocytic myocarditis. However, they are more commonly associated with giant cell myocarditis (GCM) and cardiac sarcoidosis (CS), with prevalence of 29% and 55%, respectively In addition, genetically-determined susceptibility might underlie arrhythmic myocarditis.
First, recent reports suggest that pathogenic variants in genes associated with nonischemic cardiomyopathies (NICM), hereby defined as cardiomyopathic gene variants (CGVs) are frequently found in patients with myocarditis proven by CMR and/or EMB, complicated by ventricular arrhythmias (VA). NICM constitute a heterogeneous group of diseases characterized by distinct structural and functional myocardial abnormalities in the absence of obstructive epicardial coronary artery disease. The main NICM overlapping with myocarditis are dilated (DCM) and arrhythmogenic cardiomyopathy (ACM).
Second, myocardial inflammation (M-Infl) has also been recently described in NICM complicated by arrhythmias. Preclinical data support a relevant role of M-Infl in the pathophysiology of AINICM, and its association with adverse outcomes.
Furthermore, there is a growing interest in transcriptomics in the setting of inflammatory and genetic cardiomyopathies. Cardiac transcriptome revealed specific subgroups of patients with early and overt DCM. In animal models of experimental autoimmune myocarditis, transcriptomics, transcriptomics allowed to depict the single-cell landscape of the cardiac immune cells in different phases of the disease. The addition of the cardiac transcriptome to the genotype and phenotype of patients increases the possibility for individualized medicine.
174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.
This study's planned enrollment of 262 is above the median of 208 across 120 observational studies indexed under Myocarditis.
Browse Myocarditis studies →Scientific Institute San Raffaele is the lead sponsor of 29 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Statistical analyses will be performed by certified programs (i.e. SPSS, R). For risk stratification, conventional statistical methods, including Kaplan-Meier survival analysis, univariable and multivariable logistic regression, Cox regression model, and mixed models will be used. In addition, machine learning and artificial intelligence will be applied for the setting-up of cost-effective prediction models. The best indexes for descriptive statistics, as well as optimal tests for comparing quantitative and qualitative variables, will be chosen depending on the distribution of data, as appropriate. Confidence intervals will be set at 95%. Statistical significance threshold will be set at p \<0.05 (two-sided).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with ventricular arrhythmias (VA+) and without (VA-)
Exclusion Criteria:
Patients with ventricular arrhythmias (VA+) and without (VA-)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
with ventricular arrhythmias
without ventricular arrhythmias
To provide baseline characterization of VA in the study cohort.
Prevalence of baseline VA
Time frame: Baseline
To provide baseline characterization of VA in the study cohort.
Type of VA
Time frame: baseline
To provide baseline characterization of VA in the study cohort.
Morphology of VA
Time frame: baseline
To provide follow-up characterization of VA in study cohort.
Occurrence of VA by 12 months
Time frame: 12 months
To provide follow-up characterization of VA in study cohort.
Burden of VA (number of VA events per month)
Time frame: 12 months
To screen for CGVs in study groups
Prevalence of CGVs in myocarditis with VA (VA+) vs. without VA (VA-)
Time frame: 6 months
To screen for CGVs in study groups vs healthy controls
Prevalence of CGVs in myocarditis with VA (VA+) and without VA (VA-) vs. healthy controls
Time frame: 6 months
To investigate the pathophysiological basis of arrhythmic myocarditis in study group (exploratory endpoint)
Comparison of gene expression profile on EMB in inflammatory group vs no inflammatory group
Time frame: during the procedure
To provide baseline characterization of VA according to sex
Prevalence of baseline VA in male vs female.
Time frame: Baseline
To provide baseline characterization of VA according to sex
Type of VA in male vs female.
Time frame: baseline
To provide baseline characterization of VA according to sex
Morphology of VA in male vs female
Time frame: baseline
To provide follow-up characterization of VA according to sex
Occurrence of VA by 12 months in male vs female.
Time frame: 12 months
To provide follow-up characterization of VA according to sex
Burden of VA (number of VA events per month) in male vs female.
Time frame: 12 months
To screen for CGVs in study groups
Prevalence of CGVs in myocarditis with VA (VA+) vs without VA (VA-)
Time frame: 6 months
To screen for CGVs in study groups vs healthy controls
Prevalence of CGVs in myocarditis with VA (VA+) and without VA (VA-) vs healthy controls
Time frame: 6 months
To investigate the pathophysiological basis of arrhythmic myocarditis according to sex (exploratory endpoint)
Comparison of gene expression profile on EMB in inflammatory group vs no inflammatory group, in male vs female
Time frame: during the procedure
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Scientific Institute San Raffaele