Image-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-control Study

NCT06730607 | Recruiting DMC

• 1 other identifier: MYOCARDITIS-VT
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief Summary

Ventricular arrhythmias (VAs) are frequently associated with structural heart diseases (SHD) such as myocardial infarction, myocarditis, and non-ischemic cardiomyopathies. Myocardial fibrotic tissue plays a central role in the genesis and the maintenance of re-entrant VAs associated with post-myocarditis sequelae and late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful tool for the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Moreover, a post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain) allows to analyze the CMR-derived data and to characterize the scar architecture, differentiating between dense (scar core zone) and more diffuse (border zone \[BZ\]) fibrosis, and identifying the BZ channels (BZCs) that are strands of healthy myocardial tissue within zones of unexcitable tissue and connect areas of normal myocardium. It was described that BZCs could serve as slow-conducting reentrant pathways and are critical to entail VA in ischemic and non-ischemic heart disease. However, the pathophysiological role and the correlation between scar architecture and VAs in post-myocarditis patients is yet to be defined. To date, the standard-of-care evaluation for primary prevention implantable cardioverter-defibrillator (ICD) therapy is LVEF-based, leading to the fact that the contemporary rate of appropriated therapies is very low. Moreover, events may also occur in patients with normal to moderately depressed LVEF, which is particularly relevant, as it constitutes the most prevalent population of patients exposed to an increased risk of VAs. Multiple studies reported that LGE at CMR is a strong and specific predictor of VT occurrence and sudden death in post-myocarditis patients. There were reported cases in which even after the normalization of LVEF, the extension of LGE, the scar architecture, and the presence of BZCs at cMR analysis are determinants of the arrhythmic risk in post-myocarditis patients. The Investigators sought to evaluate the usefulness of CMR-derived scar architecture analysis to predict the occurrence of VT events in an international, multicenter, case-control study on unselected post-myocarditis patients without previous arrhythmia evidence. Aim of the study is also to assess the net reclassification improvement (NRI) for the indication of primary prevention ICD implantation using CMR data and post-processing data as compared to LVEF-based indication

Conditions

Myocarditis; Ventricular Arrhythmia

Keywords

myocarditis; ventricular arrhythmias; sudden cardiac death; cardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

• Number of patients presenting one of sudden cardiac death, sustained ventricular arrhythmia, or defibrillator therapy.

  The primary endpoint will be the clinical composite of sudden cardiac death or any sustained ventricular arrhythmia. The endpoint will be retrospectively correlated with the cMR-derived findings.

  2 years

Study Arms (2)

Cases: patients with sudden cardiac death or sustained ventricular arrhythmias during the follow-up

Inclusion criteria Patients will only be recruited if they fulfill ALL the inclusion criteria: 1. Age \> 18 years. 2. Myocarditis diagnosis \> 6 months before the inclusion in the study. 3. Signed informed consent. 4. CMR performed \> 6 months after myocarditis diagnosis Exclusion criteria Patients will be excluded if they meet ANY of the following exclusion criteria: * Age \< 18 years. * Pregnancy. * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Active myocarditis * Myocarditis diagnosis \< 6 months * Previously documented sustained ventricular arrhythmias. * Impossibility or contraindications to undergo LGE-CMR. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Controls:patients without sudden cardiac death or sustained ventricular arrhythmias during follow-up

Patients will only be recruited if they fulfill ALL the inclusion criteria: 1. Age \> 18 years. 2. Myocarditis diagnosis \> 6 months before the inclusion in the study. 3. Signed informed consent. 4. CMR performed \> 6 months after myocarditis diagnosis Patients will be excluded if they meet ANY of the following exclusion criteria: * Age \< 18 years. * Pregnancy. * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Active myocarditis * Myocarditis diagnosis \< 6 months * Previously documented sustained ventricular arrhythmias. * Impossibility or contraindications to undergo LGE-CMR. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with previous myocarditis and a cardiac magnetic resonance performed at least 6 months after the diagnosis

You may qualify if:

• Age \> 18 years.
• Signed informed consent.
• CMR performed \> 6 months after myocarditis diagnosis

You may not qualify if:

• Age \< 18 years.
• Pregnancy.
• Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
• Active myocarditis
• Myocarditis diagnosis \< 6 months
• Previously documented sustained ventricular arrhythmias.
• Impossibility or contraindications to undergo LGE-CMR.
• Concomitant investigation treatments.
• Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (3)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, Pisa, 56126, Italy

RECRUITING

Teknon Medical Center

Barcelona, Barcelona, 08022, Spain

RECRUITING

Related Publications (4)

• Acosta J, Fernandez-Armenta J, Borras R, Anguera I, Bisbal F, Marti-Almor J, Tolosana JM, Penela D, Andreu D, Soto-Iglesias D, Evertz R, Matiello M, Alonso C, Villuendas R, de Caralt TM, Perea RJ, Ortiz JT, Bosch X, Serra L, Planes X, Greiser A, Ekinci O, Lasalvia L, Mont L, Berruezo A. Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study. JACC Cardiovasc Imaging. 2018 Apr;11(4):561-572. doi: 10.1016/j.jcmg.2017.04.021. Epub 2017 Aug 2.

  PMID: 28780194 BACKGROUND

• Jauregui B, Soto-Iglesias D, Penela D, Acosta J, Fernandez-Armenta J, Linhart M, Ordonez A, San Antonio R, Teres C, Chauca A, Carreno JM, Scherer C, Falasconi G, Prat-Gonzalez S, Perea RJ, Mont L, Bosch X, Ortiz-Perez JT, Berruezo A. Cardiovascular magnetic resonance determinants of ventricular arrhythmic events after myocardial infarction. Europace. 2022 Jul 15;24(6):938-947. doi: 10.1093/europace/euab275.

  PMID: 34849726 BACKGROUND

• Di Marco A, Brown P, Mateus G, Faga V, Nucifora G, Claver E, Viedma J, Galvan F, Bradley J, Dallaglio PD, de Frutos F, Miller CA, Comin-Colet J, Anguera I, Schmitt M. Late gadolinium enhancement and the risk of ventricular arrhythmias and sudden death in NYHA class I patients with non-ischaemic cardiomyopathy. Eur J Heart Fail. 2023 May;25(5):740-750. doi: 10.1002/ejhf.2793. Epub 2023 Feb 22.

  PMID: 36781200 BACKGROUND

• Peretto 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.

  PMID: 32138965 BACKGROUND

MeSH Terms

Conditions

Myocarditis; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmia Department

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 12, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (2)