Predicting Ventricular Tachycardias in Patients After Myocarditis
Image-Based Prediction of Ventricular Tachycardia Events in Post-Myocarditis Patients: an International Multicenter Case-control Study
This study is trying to see if the amount of scar tissue in the hearts of people who have recovered from myocarditis can help predict their risk of serious heart problems like sudden cardiac death or fast heartbeats.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Medico Teknon Academic / other |
| Locations | 3 sites (Rozzano, Milan and 2 other locations) |
| Trial ID | NCT06730607 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the risk of sudden cardiac death and sustained ventricular tachycardia in patients who have recovered from myocarditis. It utilizes late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) to assess scar tissue and identify channels of healthy myocardial tissue within scarred areas. The study will evaluate the relationship between the amount of scar tissue and the risk of arrhythmias, focusing on patients without prior arrhythmia evidence. The findings could help in better risk stratification and management of post-myocarditis patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have been diagnosed with myocarditis for more than six months and have undergone LGE-CMR.
Not a fit: Patients under 18, those with active myocarditis, or individuals with other structural heart diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients recovering from myocarditis, potentially reducing the incidence of life-threatening arrhythmias.
How similar studies have performed: While similar studies have explored the relationship between myocardial scarring and arrhythmias, this specific approach using advanced imaging techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rozzano, Milan and 2 other locations
- Humanitas Research Hospital — Rozzano, Milan, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Pisana — Pisa, Pisa, Italy (Recruiting)
- Teknon Medical Center — Barcelona, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.