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Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway

NCT05610423 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

no intervention

No intervention. Observational study only

Sponsors & Collaborators

  • Norwegian Institute of Public Health

    collaborator OTHER_GOV

  • Norwegian Medicines Agency

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Nina E Hasselberg, MD, PhD · Oslo University Hospital

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2032-12-31
Completion
2032-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610423 on ClinicalTrials.gov