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

NCT ID: NCT06730607

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-02

Study Completion Date

2026-12-30

Brief Summary

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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

Detailed Description

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Research hypothesis

The composite outcome is:

* sudden cardiac death, sustained VT, syncopal VT or appropriate ICD therapy (ATP and/or shock) in ICD carriers in primary prevention, or
* sudden cardiac death, sustained VT, syncopal VT detected by any diagnostic test (i.e., 24 h Holter monitoring, prolonged Holter monitoring, urgency ECG etc.) in no ICD-carriers.

Our research hypothesis is that the composite outcome will be higher in those patients with greater scar mass and BZC mass.

Primary objective To analyze the composite outcome of sudden cardiac death or sustained ventricular tachycardia (either treated by an ICD or documented by any diagnostic method) in post-myocarditis patients with no previous arrhythmia evidence, according to their risk classification by means of BZC mass.

Secondary objectives

To analyze the relationship between the primary outcome and other variables:

* LVEF
* Scar mass
* BZ mass
* Core mass
* Presence and number of tissue channels within the scar, as detected by cardiac CT
* Age
* Time since myocarditis

Conditions

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Myocarditis Ventricular Arrhythmia

Keywords

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myocarditis ventricular arrhythmias sudden cardiac death cardiac magnetic resonance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Medico Teknon

OTHER

Sponsor Role lead

Responsible Party

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Antonio Berruezo, MD, PhD

Head of Arrhythmia Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, Pisa, Italy

Site Status RECRUITING

Teknon Medical Center

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Italy Spain

Facility Contacts

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Diego Penela Maceda, MD, PhD

Role: primary

Giulio Zucchelli, MD, PhD

Role: primary

Antonio Berruezo, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28780194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34849726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36781200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32138965 (View on PubMed)

Other Identifiers

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MYOCARDITIS-VT

Identifier Type: -

Identifier Source: org_study_id