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Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway

Key facts

Where
Oslo, NorwaySee the site

Where in Norway

  • Oslo University HospitalOslo, NorwayNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Oslo University Hospital
Trial code
NCT05610423
Record updated
1 August 2023
Original description
This is a national multicenter study in Norway investigating of individuals with Covid-19 vaccine associated myocarditis (VAM) and pericarditis in Norway.Read full original descriptionShow less

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.

Inclusion: Confirmed myocarditis (definite, probable, possible) by Brighton criteria < 90 days after either Covid-19 vaccine.

Exclusion: Other more likely cause of myocarditis, including Covid-19 infection.

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.

ClinicalTrials.gov NCT05610423