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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Medico Teknon

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years.

Myocarditis diagnosis > 6 months before the inclusion in the study.

Signed informed consent.

CMR performed > 6 months after myocarditis diagnosis

Disqualifiers

Age < 18 years.

Pregnancy.

Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)

Active myocarditis

Trial population

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

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Cases: patients with sudden cardiac death or sustained ventricular arrhythmias during the follow-up
Group B: Controls:patients without sudden cardiac death or sustained ventricular arrhythmias during follow-up

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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