Under construction – not a live service
Sign in
Taking people in ItalyNo phase

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

Key facts

Who runs it
Centro Medico Teknon
Where
Pisa and Rozzano, ItalySee the 2 sitesAlso in 1 other country, 1 site
Trial code
Status
Recruiting
People taking part
150 people, planned
Started
2 Dec 2024
Expected to end
30 Dec 2026
Type of study
Observational, 2 groups
Record updated
12 December 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Age > 18 years
  • Myocarditis diagnosis > 6 months before the inclusion in the study
  • Signed informed consent
  • CMR performed > 6 months after myocarditis diagnosis

Who cannot take part

  • Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
  • Previously documented sustained ventricular arrhythmias
  • Concomitant investigation treatments
  • Age < 18 years
  • Pregnancy
  • Active myocarditis
  • Myocarditis diagnosis < 6 months
  • Impossibility or contraindications to undergo LGE-CMR
  • 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

Where in Italy

Also in 1 other country, 1 site

  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyContact: Giulio Zucchelli, MD, PhDTaking people
  • Humanitas Research HospitalRozzano, ItalyContact: Diego Penela Maceda, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Image-Based Prediction of Ventricular Tachycardia Events in Post-Myocarditis Patients: an International Multicenter Case-control Study
Record updated
12 December 2024