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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years.

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

• Signed informed consent.

• CMR performed \> 6 months after myocarditis diagnosis

Locations
Other Locations
Italy
Azienda Ospedaliero-Universitaria Pisana
RECRUITING
Pisa
Humanitas Research Hospital
RECRUITING
Rozzano
Spain
Teknon Medical Center
RECRUITING
Barcelona
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 150
Treatments
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
Sponsors
Leads: Centro Medico Teknon

This content was sourced from clinicaltrials.gov