Registry of Inflammatory Heart Disease After COVID-19 Vaccination Tracking Myocarditis and Pericarditis Cases and Controls

What this Trial Is About

Myocarditis and pericarditis are inflammatory diseases of the heart muscle and surrounding tissue, which can occur due to various causes including vaccines. This research investigates cases of inflammatory heart disease that developed after receiving COVID-19 vaccines, focusing on symptoms like chest pain and shortness of breath that appear within 2 to 10 days post-vaccination, often after the second dose. The study includes both a retrospective review and a prospective case-control design to better understand this condition. The study has two parts first, a retrospective chart review to establish a database of patients previously diagnosed with vaccine-related myocarditis or pericarditis. Second, a prospective case-control study will enroll patients who develop symptoms within 42 days of COVID-19 vaccination, along with controls who have been vaccinated but did not develop symptoms. Clinical information and blood samples will be collected at baseline and during a follow-up visit 4 to 12 weeks later, with ongoing telephone interviews at 6 months, 12 months, and yearly up to 4 years. Participants will undergo clinical assessments and blood tests at initial and follow-up visits, and complete quality-of-life questionnaires. Researchers will track serious cardiac events, recurrence of symptoms, arrhythmias, cardiovascular mortality, and overall quality of life over the study period. The long-term follow-up via telephone interviews and record reviews will help monitor the participants clinical status and health outcomes for up to four years.

COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry