NCT06730607 Image-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-control Study
| NCT ID | NCT06730607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Medico Teknon |
| Condition | Myocarditis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-12-02 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT06730607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06730607 currently recruiting?
Yes, NCT06730607 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centro Medico Teknon to inquire about joining.
Where is the NCT06730607 trial being conducted?
This trial is being conducted at Rozzano, Italy, Pisa, Italy, Barcelona, Spain.
Who is sponsoring the NCT06730607 clinical trial?
NCT06730607 is sponsored by Centro Medico Teknon. The trial plans to enroll 150 participants.