Actively Recruiting

Age: 18Years +
All Genders
NCT06730607

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

Led by Centro Medico Teknon · Updated on 2024-12-12

150

Participants Needed

3

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of myocarditis more than 6 months before joining the study
  • Signed informed consent to participate
  • Cardiac magnetic resonance imaging performed more than 6 months after myocarditis diagnosis
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Pregnancy
  • Other structural heart diseases, such as congenital or non-ischemic heart diseases
  • Active myocarditis
  • Myocarditis diagnosed less than 6 months ago
  • Previously documented sustained ventricular arrhythmias
  • Cannot or should not undergo late gadolinium enhancement cardiac magnetic resonance imaging
  • Receiving other investigational treatments
  • Medical, geographical, or social reasons that make participation impractical
  • Refusal to provide written informed consent

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Humanitas Research Hospital

Rozzano, Milan, Italy, 20089

Actively Recruiting

2

Azienda Ospedaliero-Universitaria Pisana

Pisa, Pisa, Italy, 56126

Actively Recruiting

3

Teknon Medical Center

Barcelona, Barcelona, Spain, 08022

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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