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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-80
SponsorScientific Institute San Raffaele

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Obstructive coronary artery disease, or lack of coronary angiography/computed tomography (CT) scan in patients >40 years.

Absent informed consent.

Trial population

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).

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

262 Participants
are grouped into 2 trial groups
Group A: VA+
Group B: VA-

Trial outcomes

Primary outcomes

1

To provide baseline characterization of VA in the study cohort.

Prevalence of baseline VA

Time frame
Baseline
2

To provide baseline characterization of VA in the study cohort.

Type of VA

Time frame
baseline
3

To provide baseline characterization of VA in the study cohort.

Morphology of VA

Time frame
baseline
4

To provide follow-up characterization of VA in study cohort.

Occurrence of VA by 12 months

Time frame
12 months

Secondary outcomes

1

To provide baseline characterization of VA according to sex

Prevalence of baseline VA in male vs female.

Time frame
Baseline
2

To provide baseline characterization of VA according to sex

Type of VA in male vs female.

Time frame
baseline
3

To provide baseline characterization of VA according to sex

Morphology of VA in male vs female

Time frame
baseline
4

To provide follow-up characterization of VA according to sex

Occurrence of VA by 12 months in male vs female.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.