NCT05610423

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
81mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Sep 2022Dec 2032

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

10.3 years

First QC Date

November 1, 2022

Last Update Submit

July 28, 2023

Conditions

Myocarditis

Keywords

Vaccine side effectLong term cardiac follow up

Outcome Measures

Primary Outcomes (6)

  • Presence of myocardial scar

    Quantification of myocardial scar by cardiac magnetic resonance (CMR).

    1 year post myocarditis

  • Reduced myocardial function

    Assessment of myocardial function by echocardiography and CMR

    1 year post myocarditis

  • Presence of supraventricular arrhythmias

    Presence, frequency and type supraventricular arrhythmias detected on ECG and 24 hours Holter ECG recording

    1 year post myocarditis

  • Presence of ventricular arrhythmias

    Presence, frequency and type of ventricular arrhythmias detected on ECG and 24 hours Holter ECG

    1 year post myocarditis

  • Persisting cardiac symptoms.

    Participant reporting shortness of breath,chest pain, dizziness, syncope, fatigue.

    2 years post myocarditis

  • All cause death

    Register death by cause

    1 year post myocarditis

Secondary Outcomes (6)

  • Presence of myocardial scar

    2 years post myocarditis

  • Reduced myocardial function

    2 years post myocarditis

  • Presence of supraventricular arrhythmias

    2 years post myocarditis

  • Presence of ventricular arrhythmias

    2 years post myocarditis

  • Persisting cardiac symptoms.

    2 years post myocarditis

  • +1 more secondary outcomes

Study Arms (1)

Covid-19 vaccine associated myocarditis

No intervention

Other: no intervention

Interventions

no interventionOTHER

No intervention. Observational study only

Covid-19 vaccine associated myocarditis

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Covid-19 vaccine associated myocarditis and pericarditis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be drawn from study participants for routine biochemistry. By separate consent from participants, blood will be stored in a study specific biobank pending analyses, including genetic analyses by whole genome sequencing to search for genetic variants associated with vaccine associated myocarditis.

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Officials

  • Nina E Hasselberg, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant cardiologist

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 9, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)