MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-23

Study Completion Date

2025-04-23

Brief Summary

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Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the lining surrounding the heart muscle. Symptoms of these conditions can include pain in the chest and rapid or irregular heartbeat. There are many different causes for myocarditis and pericarditis including COVID-19 infection.

The MYCOVACC study will identify patients using local screening strategies, including research communications, care provider referrals, and medical record review. The retrospective component of the study will collect information about patients suffering from vaccine associated myopericarditis and COVID-19 associated myopericarditis. Consenting patients will then be prospectively followed according to standard of care protocols. The main objectives of MYCOVACC are to describe the rate of major adverse cardiovascular events, functional outcomes including quality of life, and myocardial recovery through imaging.

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Detailed Description

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Conditions

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Myocarditis Myocarditis Acute Pericarditis Pericarditis Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mRNA COVID-19 vaccine associated myocarditis

Participants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Intervention Type DIAGNOSTIC_TEST

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives

mRNA COVID-19 vaccine associated pericarditis

Participants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Intervention Type DIAGNOSTIC_TEST

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives

COVID-19 infection associated myocarditis

Participants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Intervention Type DIAGNOSTIC_TEST

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives

COVID-19 infection associated pericarditis

Participants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Intervention Type DIAGNOSTIC_TEST

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives

Alternative etiology myocarditis

Any participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection

Baseline Quality of Life questionnaire

Intervention Type OTHER

Only baseline quality of life questionnaires will be utilized in the alternative etiology myocarditis cohort as they will not be followed up in the study

Interventions

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Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire

Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire will be used to follow the clinical outcomes and patient reported outcomes to assess for study objectives

Intervention Type DIAGNOSTIC_TEST

Baseline Quality of Life questionnaire

Only baseline quality of life questionnaires will be utilized in the alternative etiology myocarditis cohort as they will not be followed up in the study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. COVID-19 vaccination within previous 42 days. AND
2. At least one cardiac symptom of suspected myocarditis/pericarditis (Appendix 5).

OR At least two non-specific symptoms (Appendix 5). OR In infants and young children, at least two non-specific pediatric symptoms (Appendix 5).

OR No symptoms, but abnormal histopathology or a combination of abnormal cardiac biomarkers with abnormal cardiac imaging (echo or MRI).

AND
3. At least one of the following objective findings (Brighton Criteria case definitions, Appendices 1 to 5):

1. Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation.
2. Elevated myocardial biomarker (Troponin T, Troponin I, or CK-MB).
3. Cardiac MRI abnormality.
4. Echocardiographic abnormality.
5. New or worsening arrhythmia on electrocardiogram, Holter monitor, or telemetry.
6. Elevated inflammation biomarkers: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), hs-CRP, or D-Dimer.
7. Physical examination pericardial friction rub or pulsus paradoxus.
8. Pericardial fluid or inflammation by imaging (echo, MRI, or CT).
9. Enlarged heart on chest radiograph.

AND
4. No alternative cause of presentation. e.g. infectious or autoimmune myocarditis.

1. COVID-19 infection within the previous 42 days.

AND
2. Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.

AND
3. No alternative cause of presentation.

1. Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.

AND
2. No alternative cause of presentation.

Exclusion Criteria

* For prospective invitation and follow-up, inability to provide informed consent. Consent will be sought from patients or their authorised substitute decision maker.
* Patients not fulfilling Brighton Criteria levels 1-3 will be excluded if they are level 4 (insufficient evidence for myocarditis) or Level 5 (not myocarditis) or have an alternative diagnosis such as myocardial infarction.

Eligible Sex

ALL

Accepts Healthy Volunteers

No