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

Myocarditis Clinical Trial

— MYCOVACC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103123
• Other study ID #: MYCOVACC
• Status: Recruiting
• Start date: April 23, 2023
• Est. completion date: April 23, 2025

Study information

• Verified date: October 2023
• Source: Cardiology Research UBC
• Contact: Jenny Petterson, MSc
• Phone: 604-875-5104
• Email: jenny.petterson[@]vch.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 23, 2025
• Est. primary completion date: March 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Inclusion criteria for vaccine associated myocarditis/pericarditis.

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.

• Inclusion criteria for COVID-19 associated myocarditis/pericarditis

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.

Inclusion criteria alternative etiology myocarditis.

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.

Related Conditions & MeSH terms

• Myocarditis
• Myocarditis Acute
• Pericarditis
• Pericarditis Acute

Intervention

Diagnostic Test:
• 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

Other:
• 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

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cardiology Research UBC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Death from any cause.; Ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia).; Heart block (type II or type III block).; Heart failure (national guideline criteria).; Left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] <55%).; Cardiac tamponade.	From date of vaccination and up to 3 years
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Rate of atrial arrhythmias after mRNA COVID-19 vaccination?		From date of vaccination for up to three years
Secondary	Rate of all-cause and cardiovascular mortality after mRNA COVID-19 vaccination?		From date of vaccination for up to three years
Secondary	Rate of all-cause and cardiovascular hospitalization after mRNA COVID-19 vaccination?		From date of vaccination for up to three years
Secondary	Rate of recurrence of myocarditis/pericarditis after mRNA COVID-19 vaccination?		From date of vaccination for up to three years
Secondary	Rate of constrictive pericarditis after mRNA COVID-19 vaccination?		From date of vaccination for up to three years

External Links

•   Related Info