← Back to all trials
Enrolling By Invitation
NCT05610423
Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
Conditions: Myocarditis
Sex: All
Ages: 5 Years – N/A
Enrollment: 100
Sponsor: Oslo University Hospital
Location: Norway
Summary
This is a national multicenter study in Norway investigating of individuals with Covid-19 vaccine associated myocarditis (VAM) and pericarditis in Norway.The main objective is to validate the reported possible cases of Covid-19 vaccine associated myo-and pericarditis in Norway as well as investigate for predisposing factors and risk factors for developing these vaccine adverse events.Furthermore, patients with confirmed Covid-19 VAM, will be invited to participate in a prospective cohort study, investigating for cardiac long-term adverse effects 1 year and 2 years after vaccine-associated myocarditis.
Eligibility Criteria
Part 1 Individuals identified with possible Covid-19 vaccine associated myocarditis and pericarditis, by linkage of diagnosis of myocarditis and pericarditis (from Norwegian Patient Registry, NPR) and vaccination data (Immunization registry, SYSVAK).Part 2.Inclusion Criteria:Confirmed myocarditis (definite, probable, possible) by Brighton criteria < 90 days after either Covid-19 vaccine.Exclusion Criteria:Other more likely cause of myocarditis, including Covid-19 infection.
Source: ClinicalTrials.gov (NCT05610423). StuddyBuddy aggregates publicly available trial information.