Myocarditis Clinical Trial
Official title:
Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
Verified date | July 2023 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | December 31, 2032 |
Est. primary completion date | December 31, 2032 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Norwegian Institute of Public Health, Norwegian Medicines Agency |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of myocardial scar | Quantification of myocardial scar by cardiac magnetic resonance (CMR). | 1 year post myocarditis | |
Primary | Reduced myocardial function | Assessment of myocardial function by echocardiography and CMR | 1 year post myocarditis | |
Primary | Presence of supraventricular arrhythmias | Presence, frequency and type supraventricular arrhythmias detected on ECG and 24 hours Holter ECG recording | 1 year post myocarditis | |
Primary | Presence of ventricular arrhythmias | Presence, frequency and type of ventricular arrhythmias detected on ECG and 24 hours Holter ECG | 1 year post myocarditis | |
Primary | Persisting cardiac symptoms. | Participant reporting shortness of breath,chest pain, dizziness, syncope, fatigue. | 2 years post myocarditis | |
Primary | All cause death | Register death by cause | 1 year post myocarditis | |
Secondary | Presence of myocardial scar | Quantification of myocardial scar by cardiac magnetic resonance (CMR). | 2 years post myocarditis | |
Secondary | Reduced myocardial function | Assessment of myocardial function by echocardiography and CMR | 2 years post myocarditis | |
Secondary | Presence of supraventricular arrhythmias | Presence, frequency and type supraventricular arrhythmias detected on ECG and 24 | 2 years post myocarditis | |
Secondary | Presence of ventricular arrhythmias | Presence, frequency and type of ventricular arrhythmias detected on ECG and 24 hours | 2 years post myocarditis | |
Secondary | Persisting cardiac symptoms. | Participant reporting shortness of breath,chest pain, dizziness, syncope, fatigue. | 2 years post myocarditis | |
Secondary | All cause death | Register death by cause | 2 years post myocarditis |
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