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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA COVID-19 vaccine associated myocarditis | Participants who had developed myocarditis within 42 days of getting a mRNA COVID-19 vaccine |
| |
| mRNA COVID-19 vaccine associated pericarditis | Participants who had developed pericarditis within 42 days of getting a mRNA COVID-19 vaccine |
| |
| COVID-19 infection associated myocarditis | Participants who had developed myocarditis within 42 days of being infected with the SARS-COV-2 virus |
| |
| COVID-19 infection associated pericarditis | Participants who had developed pericarditis within 42 days of being infected with the SARS-COV-2 virus |
| |
| Alternative etiology myocarditis | Any participants with myocarditis that is not associated with the mRNA COVID-19 vaccine or SARS-COV-2 viral infection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Major Adverse Cardiac Event (MACE) at 30 days post vaccination (preferred by cardiovascular community) and at 42 days post vaccination (preferred by vaccine monitoring investigators) | Including any of:
| From date of vaccination and up to 3 years |
| Recovery of cardiac function in patients with previously documented abnormal cardiac function | Patients with Left Ventricular Ejection Fraction (LVEF)<55% during anytime at baseline, with LVEF increase by 5% from worst baseline measurement | Through study completion, an average of 3 years |
| Quality of life using validated instruments at baseline, 3 months, 12 months, and annually | Quality of life: EQ-5D-5L questionnaire for adults or EQ-5D-Y questionnaire for children. | Through study completion, an average of 3 years |
| Depression and anxiety using validated instruments at baseline, 3 months, 12 months, and annually | Depression and anxiety data: PHQ-9 and GAD-7. | Through study completion, an average of 3 years |
| Physical activity using validated instruments at baseline, 3 months, 12 months, and annually | Physical activity: International Activity Questionnaire. | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Individual components of primary composite endpoint at 30 days and 42 days post mRNA COVID-19 vaccination? | From date of vaccination for up to three years | |
| Rate of atrial arrhythmias after mRNA COVID-19 vaccination? | From date of vaccination for up to three years |
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Inclusion Criteria:
Inclusion criteria for vaccine associated myocarditis/pericarditis.
COVID-19 vaccination within previous 42 days. AND
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
At least one of the following objective findings (Brighton Criteria case definitions, Appendices 1 to 5):
AND
No alternative cause of presentation. e.g. infectious or autoimmune myocarditis.
Inclusion criteria for COVID-19 associated myocarditis/pericarditis
COVID-19 infection within the previous 42 days.
AND
Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
AND
No alternative cause of presentation.
Inclusion criteria alternative etiology myocarditis.
Myocarditis/pericarditis as per Brighton Criteria for vaccine associated myocarditis/pericarditis.
AND
No alternative cause of presentation.
Exclusion Criteria:
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Patients who have suffered or are suffering from 1) COVID-19 infection associated myocarditis, 2) COVID-19 infection associated pericarditis, 3) COVID-19 vaccine associated myocarditis, 4) COVID-19 vaccine associated pericarditis, 5) Alternative etiology myocarditis, 6) Alternative etiology pericarditis
Definition of myocarditis and pericarditis follows standard clinical definition as outlined in "Brighton Collaboration myocarditis case definition and levels of diagnostic certainty 1,2 and 3"
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Petterson, MSc | Contact | 604-875-5104 | jenny.petterson@vch.ca | |
| Naomi Uchida, RN | Contact | 604-875-5324 | naomi-uchida@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Hawkins, MD | Vancouver General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2023 | Jul 14, 2023 |
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| Baseline Quality of Life questionnaire | 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 |
|
| Rate of all-cause and cardiovascular mortality after mRNA COVID-19 vaccination? | From date of vaccination for up to three years |
| Rate of all-cause and cardiovascular hospitalization after mRNA COVID-19 vaccination? | From date of vaccination for up to three years |
| Rate of recurrence of myocarditis/pericarditis after mRNA COVID-19 vaccination? | From date of vaccination for up to three years |
| Rate of constrictive pericarditis after mRNA COVID-19 vaccination? | From date of vaccination for up to three years |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D009205 | Myocarditis |
| D010493 | Pericarditis |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D059552 | Caves |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D055593 | Geological Phenomena |
| D055585 | Physical Phenomena |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
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