MyocarditisGEAMNCT06889662
GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.
An observational study of Myocarditis and Ventricular Arrythmia, run by Scientific Institute San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocarditis, Ventricular Arrythmia
- How many people
- 262 participants
- Where
- 1 siteItaly
- Study dates
- 25 Feb 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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).
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute San Raffaele
Milan, Italy/Milan, 20132
Giovanni Peretto, Medical Doctor, PhD, 39+ 0226437340, peretto.giovanni@gmail.com
About this study
Official title: GEAM: Yield of GEnetic Testing in Arrhythmic Myocarditis
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.
Read the detailed description
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.
- Conditions
- Myocarditis, Ventricular Arrythmia
- Keywords
- Arrhythmogenic cardiomyopathy, Ventricular arrhythmias, Myocardial inflammation
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VA+ | with ventricular arrhythmias | |
| VA- | without ventricular arrhythmias |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide baseline characterization of VA in the study cohort.
Prevalence of baseline VA
Measured: Baseline
To provide baseline characterization of VA in the study cohort.
Type of VA
Measured: baseline
To provide baseline characterization of VA in the study cohort.
Morphology of VA
Measured: baseline
To provide follow-up characterization of VA in study cohort.
Occurrence of VA by 12 months
Measured: 12 months
To provide follow-up characterization of VA in study cohort.
Burden of VA (number of VA events per month)
Measured: 12 months
To screen for CGVs in study groups
Prevalence of CGVs in myocarditis with VA (VA+) vs. without VA (VA-)
Measured: 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
Measured: 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
Measured: during the procedure
Secondary outcomes (8)
To provide baseline characterization of VA according to sex
Prevalence of baseline VA in male vs female.
Measured: Baseline
To provide baseline characterization of VA according to sex
Type of VA in male vs female.
Measured: baseline
To provide baseline characterization of VA according to sex
Morphology of VA in male vs female
Measured: baseline
To provide follow-up characterization of VA according to sex
Occurrence of VA by 12 months in male vs female.
Measured: 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.
Measured: 12 months
To screen for CGVs in study groups
Prevalence of CGVs in myocarditis with VA (VA+) vs without VA (VA-)
Measured: 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
Measured: 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
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start25 Feb 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Peretto, Scientific Institute San Raffaele
- Investigators
- Paolo Della Bella, MD, Study chair, Scientific Institute San Raffaele, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889662
- Sponsor's protocol ID
- GEAM
- Acronym
- GEAM
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tedesco M, Giannese F, Lazarevic D, Giansanti V, Rosano D, Monzani S, Catalano I, Grassi E, Zanella ER, Botrugno OA, Morelli L, Panina Bordignon P, Caravagna G, Bertotti A, Martino G, Aldrighetti L, Pasqualato S, Trusolino L, Cittaro D, Tonon G. Chromatin Velocity reveals epigenetic dynamics by single-cell profiling of heterochromatin and euchromatin. Nat Biotechnol. 2022 Feb;40(2):235-244. doi: 10.1038/s41587-021-01031-1. Epub 2021 Oct 11.
PubMed 34635836Tiron C, Campuzano O, Fernandez-Falgueras A, Alcalde M, Loma-Osorio P, Zamora E, Caballero A, Sarquella-Brugada G, Cesar S, Garcia-Cuenllas L, Garcia-Alvarez A, Jorda P, Arbelo E, Tomas-Querol C, Pineda V, Martinez D, Brugada R. Prevalence of Pathogenic Variants in Cardiomyopathy-Associated Genes in Myocarditis. Circ Genom Precis Med. 2022 Jun;15(3):e003408. doi: 10.1161/CIRCGEN.121.003408. Epub 2022 May 6. No abstract available.
PubMed 35522179Peretto G, Casella M, Merlo M, Benedetti S, Rizzo S, Cappelletto C, Di Resta C, Compagnucci P, De Gaspari M, Dello Russo A, Casari G, Basso C, Sala S, Sinagra G, Della Bella P, Cooper LT Jr. Inflammation on Endomyocardial Biopsy Predicts Risk of MACE in Undefined Left Ventricular Arrhythmogenic Cardiomyopathy. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 1):951-961. doi: 10.1016/j.jacep.2022.10.032. Epub 2023 Jan 18.
PubMed 36752457Richards S, Aziz N, Bale S, Bick D, Das S, Gastier-Foster J, Grody WW, Hegde M, Lyon E, Spector E, Voelkerding K, Rehm HL; ACMG Laboratory Quality Assurance Committee. Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med. 2015 May;17(5):405-24. doi: 10.1038/gim.2015.30. Epub 2015 Mar 5.
PubMed 25741868Peretto G, De Luca G, Villatore A, Di Resta C, Sala S, Palmisano A, Vignale D, Campochiaro C, Lazzeroni D, De Gaspari M, Rizzo S, Busnardo E, Ferro P, Gianolli L, Basso C, Dagna L, Esposito A, Benedetti S, Della Bella P. Multimodal Detection and Targeting of Biopsy-Proven Myocardial Inflammation in Genetic Cardiomyopathies: A Pilot Report. JACC Basic Transl Sci. 2023 Jul 5;8(7):755-765. doi: 10.1016/j.jacbts.2023.02.018. eCollection 2023 Jul.
PubMed 37547072Peretto G, Sala S, Basso C, Rizzo S, Radinovic A, Frontera A, Limite LR, Paglino G, Bisceglia C, De Luca G, Campochiaro C, Sartorelli S, Palmisano A, Esposito A, Busnardo E, Villatore A, Baratto F, Cireddu M, Marzi A, D'Angelo G, Gulletta S, Vergara P, De Cobelli F, Dagna L, Mazzone P, Della Bella P. Inflammation as a Predictor of Recurrent Ventricular Tachycardia After Ablation in Patients With Myocarditis. J Am Coll Cardiol. 2020 Oct 6;76(14):1644-1656. doi: 10.1016/j.jacc.2020.08.012.
PubMed 33004129Peretto G, Sala S, De Luca G, Marcolongo R, Campochiaro C, Sartorelli S, Tresoldi M, Foppoli L, Palmisano A, Esposito A, De Cobelli F, Rizzo S, Thiene G, Basso C, Dagna L, Caforio ALP, Della Bella P. Immunosuppressive Therapy and Risk Stratification of Patients With Myocarditis Presenting With Ventricular Arrhythmias. JACC Clin Electrophysiol. 2020 Oct;6(10):1221-1234. doi: 10.1016/j.jacep.2020.05.013. Epub 2020 Jun 24.
PubMed 33092747Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.
PubMed 32138965Mantri M, Hinchman MM, McKellar DW, Wang MFZ, Cross ST, Parker JSL, De Vlaminck I. Spatiotemporal transcriptomics reveals pathogenesis of viral myocarditis. Nat Cardiovasc Res. 2022 Oct;1(10):946-960. doi: 10.1038/s44161-022-00138-1. Epub 2022 Oct 10.
PubMed 36970396Rizzo S, Lodder EM, Verkerk AO, Wolswinkel R, Beekman L, Pilichou K, Basso C, Remme CA, Thiene G, Bezzina CR. Intercalated disc abnormalities, reduced Na(+) current density, and conduction slowing in desmoglein-2 mutant mice prior to cardiomyopathic changes. Cardiovasc Res. 2012 Sep 1;95(4):409-18. doi: 10.1093/cvr/cvs219. Epub 2012 Jul 3.
PubMed 22764152Vermij SH, Abriel H, van Veen TA. Refining the molecular organization of the cardiac intercalated disc. Cardiovasc Res. 2017 Mar 1;113(3):259-275. doi: 10.1093/cvr/cvw259.
PubMed 28069669Ammirati E, Raimondi F, Piriou N, Sardo Infirri L, Mohiddin SA, Mazzanti A, Shenoy C, Cavallari UA, Imazio M, Aquaro GD, Olivotto I, Pedrotti P, Sekhri N, Van de Heyning CM, Broeckx G, Peretto G, Guttmann O, Dellegrottaglie S, Scatteia A, Gentile P, Merlo M, Goldberg RI, Reyentovich A, Sciamanna C, Klaassen S, Poller W, Trankle CR, Abbate A, Keren A, Horowitz-Cederboim S, Cadrin-Tourigny J, Tadros R, Annoni GA, Bonoldi E, Toquet C, Marteau L, Probst V, Trochu JN, Kissopoulou A, Grosu A, Kukavica D, Trancuccio A, Gil C, Tini G, Pedrazzini M, Torchio M, Sinagra G, Gimeno JR, Bernasconi D, Valsecchi MG, Klingel K, Adler ED, Camici PG, Cooper LT Jr. Acute Myocarditis Associated With Desmosomal Gene Variants. JACC Heart Fail. 2022 Oct;10(10):714-727. doi: 10.1016/j.jchf.2022.06.013. Epub 2022 Sep 7.
PubMed 36175056Peretto G, Sala S, Rizzo S, De Luca G, Campochiaro C, Sartorelli S, Benedetti G, Palmisano A, Esposito A, Tresoldi M, Thiene G, Basso C, Della Bella P. Arrhythmias in myocarditis: State of the art. Heart Rhythm. 2019 May;16(5):793-801. doi: 10.1016/j.hrthm.2018.11.024. Epub 2018 Nov 24.
PubMed 30476544Peretto G, Sommariva E, Di Resta C, Rabino M, Villatore A, Lazzeroni D, Sala S, Pompilio G, Cooper LT. Myocardial Inflammation as a Manifestation of Genetic Cardiomyopathies: From Bedside to the Bench. Biomolecules. 2023 Apr 4;13(4):646. doi: 10.3390/biom13040646.
PubMed 37189393Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
PubMed 23824828
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEAM: Yield of GEnetic Testing in Arrhythmic Myocarditis
- ClinicalTrials.gov ID
- NCT06889662
- Acronym / sponsor ID
- GEAM / GEAM
- Conditions
- Myocarditis, Ventricular Arrythmia
- Keywords
- Arrhythmogenic cardiomyopathy, Ventricular arrhythmias, Myocardial inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA+ | – | –with ventricular arrhythmias |
| VA- | – | –without ventricular arrhythmias |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To provide baseline characterization of VA in the study cohort.
Time frame: Baseline
Prevalence of baseline VA
To provide baseline characterization of VA in the study cohort.
Time frame: baseline
Type of VA
To provide baseline characterization of VA in the study cohort.
Time frame: baseline
Morphology of VA
To provide follow-up characterization of VA in study cohort.
Time frame: 12 months
Occurrence of VA by 12 months
To provide follow-up characterization of VA in study cohort.
Time frame: 12 months
Burden of VA (number of VA events per month)
To screen for CGVs in study groups
Time frame: 6 months
Prevalence of CGVs in myocarditis with VA (VA+) vs. without VA (VA-)
To screen for CGVs in study groups vs healthy controls
Time frame: 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)
Time frame: during the procedure
Comparison of gene expression profile on EMB in inflammatory group vs no inflammatory group
8 secondary outcomes
To provide baseline characterization of VA according to sex
Time frame: Baseline
To provide baseline characterization of VA according to sex
Time frame: baseline
To provide baseline characterization of VA according to sex
Time frame: baseline
To provide follow-up characterization of VA according to sex
Time frame: 12 months
To provide follow-up characterization of VA according to sex
Time frame: 12 months
To screen for CGVs in study groups
Time frame: 6 months
To screen for CGVs in study groups vs healthy controls
Time frame: 6 months
To investigate the pathophysiological basis of arrhythmic myocarditis according to sex (exploratory endpoint)
Time frame: during the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 34635836Tedesco M, Giannese F, Lazarevic D, Giansanti V, Rosano D, Monzani S, Catalano I, Grassi E, Zanella ER, Botrugno OA, Morelli L, Panina Bordignon P, Caravagna G, Bertotti A, Martino G, Aldrighetti L, Pasqualato S, Trusolino L, Cittaro D, Tonon G. Chromatin Velocity reveals epigenetic dynamics by single-cell profiling of heterochromatin and euchromatin. Nat Biotechnol. 2022 Feb;40(2):235-244. doi: 10.1038/s41587-021-01031-1. Epub 2021 Oct 11.
- Background: PubMed 35522179Tiron C, Campuzano O, Fernandez-Falgueras A, Alcalde M, Loma-Osorio P, Zamora E, Caballero A, Sarquella-Brugada G, Cesar S, Garcia-Cuenllas L, Garcia-Alvarez A, Jorda P, Arbelo E, Tomas-Querol C, Pineda V, Martinez D, Brugada R. Prevalence of Pathogenic Variants in Cardiomyopathy-Associated Genes in Myocarditis. Circ Genom Precis Med. 2022 Jun;15(3):e003408. doi: 10.1161/CIRCGEN.121.003408. Epub 2022 May 6. No abstract available.
- Background: PubMed 36752457Peretto G, Casella M, Merlo M, Benedetti S, Rizzo S, Cappelletto C, Di Resta C, Compagnucci P, De Gaspari M, Dello Russo A, Casari G, Basso C, Sala S, Sinagra G, Della Bella P, Cooper LT Jr. Inflammation on Endomyocardial Biopsy Predicts Risk of MACE in Undefined Left Ventricular Arrhythmogenic Cardiomyopathy. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 1):951-961. doi: 10.1016/j.jacep.2022.10.032. Epub 2023 Jan 18.
- Background: PubMed 25741868Richards S, Aziz N, Bale S, Bick D, Das S, Gastier-Foster J, Grody WW, Hegde M, Lyon E, Spector E, Voelkerding K, Rehm HL; ACMG Laboratory Quality Assurance Committee. Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med. 2015 May;17(5):405-24. doi: 10.1038/gim.2015.30. Epub 2015 Mar 5.
- Background: PubMed 37547072Peretto G, De Luca G, Villatore A, Di Resta C, Sala S, Palmisano A, Vignale D, Campochiaro C, Lazzeroni D, De Gaspari M, Rizzo S, Busnardo E, Ferro P, Gianolli L, Basso C, Dagna L, Esposito A, Benedetti S, Della Bella P. Multimodal Detection and Targeting of Biopsy-Proven Myocardial Inflammation in Genetic Cardiomyopathies: A Pilot Report. JACC Basic Transl Sci. 2023 Jul 5;8(7):755-765. doi: 10.1016/j.jacbts.2023.02.018. eCollection 2023 Jul.
- Background: PubMed 33004129Peretto G, Sala S, Basso C, Rizzo S, Radinovic A, Frontera A, Limite LR, Paglino G, Bisceglia C, De Luca G, Campochiaro C, Sartorelli S, Palmisano A, Esposito A, Busnardo E, Villatore A, Baratto F, Cireddu M, Marzi A, D'Angelo G, Gulletta S, Vergara P, De Cobelli F, Dagna L, Mazzone P, Della Bella P. Inflammation as a Predictor of Recurrent Ventricular Tachycardia After Ablation in Patients With Myocarditis. J Am Coll Cardiol. 2020 Oct 6;76(14):1644-1656. doi: 10.1016/j.jacc.2020.08.012.
- Background: PubMed 33092747Peretto G, Sala S, De Luca G, Marcolongo R, Campochiaro C, Sartorelli S, Tresoldi M, Foppoli L, Palmisano A, Esposito A, De Cobelli F, Rizzo S, Thiene G, Basso C, Dagna L, Caforio ALP, Della Bella P. Immunosuppressive Therapy and Risk Stratification of Patients With Myocarditis Presenting With Ventricular Arrhythmias. JACC Clin Electrophysiol. 2020 Oct;6(10):1221-1234. doi: 10.1016/j.jacep.2020.05.013. Epub 2020 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Della Bella, MD study chair
Scientific Institute San Raffaele, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis and Ventricular Arrythmia, run by Scientific Institute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Peretto, Medical Doctor, PhD (39+ 0226437340, peretto.giovanni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide baseline characterization of VA in the study cohort. (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06889662, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.