NCT06103123

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Cardiology Research UBC · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Myocarditis
• Myocarditis Acute
• Pericarditis
• Pericarditis Acute

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-23
• Primary completion: 2025-03-23
• Completion: 2025-04-23
• First posted: 2023-10-26
• Last updated: 2023-10-26

Locations

1 site across 1 country: Canada