MedTrace Logo

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

NCT06103123 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-10-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Cardiology Research UBC

    lead OTHER

Principal Investigators

  • Nathaniel Hawkins, MD · Vancouver General Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-23
Primary Completion
2025-03-23
Completion
2025-04-23

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103123 on ClinicalTrials.gov