Long-term effects of myocarditis after COVID-19 vaccination
Consequences of Post BNT162b2 Vaccine Myocarditis and Multiple Inflammatory Syndrome Myocarditis
Hadassah Medical Organization · NCT05288426
This study is trying to see how myocarditis and multisystem inflammatory syndrome affect people after getting a COVID-19 vaccine or infection over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Hadassah Medical Organization (other) |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05288426 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term impact of myocarditis and multisystem inflammatory syndrome (MIS) that may develop following COVID-19 vaccination or infection. The study will involve 150 patients diagnosed with myocarditis, who will undergo functional evaluations including clinical assessments, ECGs, echocardiograms, and cardiac MRIs. Blood samples will be collected to analyze various biomarkers related to heart function. Patients will also complete health-related questionnaires to assess their quality of life and cardiac symptoms over a period of 6 to 12 months post-diagnosis.
Who should consider this trial
Good fit: Ideal candidates include adults and minors diagnosed with myocarditis following COVID-19 vaccination or infection, exhibiting specific clinical symptoms and imaging findings.
Not a fit: Patients with myocardial injury due to other causes, such as acute coronary syndrome or malignancy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health outcomes of patients who experience myocarditis after vaccination, potentially guiding future clinical management.
How similar studies have performed: While there have been reports of myocarditis following COVID-19 vaccination, this specific long-term evaluation approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult males and females. * Minors male and female. Diagnosed as myocarditis: * Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP) * Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope; * Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) \< 45%, or by cardiac magnetic resonance imaging. Exclusion Criteria: * Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from myocarditis, or otherwise suffer from valvuloplasty. * Myocardial injury caused by sepsis, medical agents, or poisons; * Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
Where this trial is running
Jerusalem
- Hadassah Medical Center — Jerusalem, Israel (RECRUITING)
Study contacts
- Principal investigator: Dror Mevorach, MD — Hadassah Medical Organization
- Study coordinator: Dror Mevorach, MD
- Email: mevorachd@hadassah.org.il
- Phone: 972-2- 6777317
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.
Conditions: Myocarditis