Clinical trial NCT05610423: Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
Official title: Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myocarditis
Keywords: Vaccine side effect
Long term cardiac follow up
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: Norwegian Medicines Agency
First posted: 2022-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Covid-19 vaccine associated myocarditis and pericarditis

Brief 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.

Detailed description: Myocarditis and pericarditis following vaccination with Covid-19 vaccines has been reported as rare but unexpected and potentially severe vaccine adverse events.

In Norway, all vaccines administrated are registered in the national vaccine registry (SYSVAK). All in-hospital diagnoses are reported in a national diagnosis registry (NPR). These complete national high-quality registers allow linking diagnosis of myocarditis and pericarditis to vaccine data (date, product, dose number) on an individual level.

Oslo University Hospital, in collaboration with the Norwegian Institute of Public Health and the Norwegian Medicines Agency, will perform a study consisting of 2 parts:

Part 1 "Validation study":

Eligible patients for inclusion are all individuals with suspected / reported Covid - 19 vaccine associated pericarditis and myocarditis in Norway from 2021 and onwards. Patients will be identified by linking data from the Norwegian Patient registry NPR (ICD-10 diagnostic codes for pericarditis and myocarditis) and the Immunization registry (SYSVAK) (\< 90 days since vaccination). The diagnosis of Covid-19 vaccine associated pericarditis and myocarditis will then be confirmed or rejected by medical record search according to international accepted Brighton criteria. The Brighton collaboration criteria provide evidence levels of diagnostic certainty of myocarditis and pericarditis based on cardiac signs and symptoms, cardiac enzymes, ECG findings, imaging studies and histopathology.The criteria is used to distinguish between suspected, probable and confirmed diagnosis of myocarditis and pericarditis. Patients with another more likely reason for confirmed myocarditis or pericarditis by Brighton will not be classified with Covid-19 vaccine associated myocarditis (VAM) or pericarditis, respectively.

Part 2 "Clinical follow-up study" All patients identified in the validation study with confirmed Covid-19 VAM will be invited to participate in the prospective clinical follow-up study (all age groups, both sexes, all geographical areas of Norway). Inclusion wil be by informed consent. Data collection, symptom reporting and cardiac examinations (clinical examination, ECG, 24 hours Holter ECG, echocardiography, cardiac magnetic resonance imaging) will be performed at 1 and 2 years after a diagnosis of Covid -19 VAM. Blood analyses will be performed and a blood sample stored in a biobank in consenting participants. Clinical endpoints will be collected at 1 and 2 years follow-up.

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.

Primary outcomes:
measure: Presence of myocardial scar
timeFrame: 1 year post myocarditis
measure: Reduced myocardial function
timeFrame: 1 year post myocarditis
measure: Presence of supraventricular arrhythmias
timeFrame: 1 year post myocarditis
measure: Presence of ventricular arrhythmias
timeFrame: 1 year post myocarditis
measure: Persisting cardiac symptoms.
timeFrame: 2 years post myocarditis
measure: All cause death
timeFrame: 1 year post myocarditis
Secondary outcomes:
measure: Presence of myocardial scar
timeFrame: 2 years post myocarditis
measure: Reduced myocardial function
timeFrame: 2 years post myocarditis
measure: Presence of supraventricular arrhythmias
timeFrame: 2 years post myocarditis
measure: Presence of ventricular arrhythmias
timeFrame: 2 years post myocarditis
measure: Persisting cardiac symptoms.
timeFrame: 2 years post myocarditis
measure: All cause death
timeFrame: 2 years post myocarditis
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Nina E Hasselberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: