COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

NCT05046002 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Heart Institute Research Corporation

Phase

Observational

Started

2021-08-11

Last updated

2026-01-28

Condition(s) studied

MyocarditisPericarditis

Study summary

Myocarditis and pericarditis are inflammatory diseases of the myocardium and pericardium, and can be related to different causes, including vaccines. In the past, some people developed inflammatory heart disease after receiving a live or inactive virus vaccine (smallpox vaccine or flu vaccine). Myocarditis was also seen in people with COVID-19. More recently, many countries reported that some people have developed an inflammatory condition of the myocardium or pericardium after receiving a vaccine for COVID-19.

After the COVID-19 vaccination campaigns, doctors have noticed more people presenting to the Emergency Department with chest pain and shortness of breath after receiving the vaccine, symptoms that resemble myocarditis or pericarditis. These symptoms may start between 2 to 10 days following vaccination and are frequently noticed after the second dose of the vaccines. While pericarditis seems to affect people of various age groups and gender, myocarditis is more commonly seen in young males.

The study will consist of two components. 1) The vaccine-induced inflammatory heart disease database will be established. There will be a retrospective chart review looking at vaccine myocarditis/pericarditis (Brighton Criteria Levels 1-3).

2\) There will be a prospective, pragmatic design case-control study for vaccine myocarditis/pericarditis. Follow-up telephone interview will be conducted at 6 months, 12 months and yearly up to 4 years. A record search will also be performed at 6 months, 12 months and yearly for 4 years.

The retrospective component of the study will be conducted by identifying patients previously diagnosed with this condition at participating centres.

Eligibility

Sex

ALL

Min age

5 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: 1. All patients eligible for vaccination with a COVID-19 vaccine, 2. At least one cardiac symptom of suspected myocarditis/pericarditis within 42 days of receiving a COVID-19 vaccination. The clinical symptoms include chest pain, pressure, or discomfort; dyspnea, shortness of breath/dyspnea/pain with breathing, palpitations, diaphoresis, syncope, or sudden death. OR At least two non-specific symptoms within 42 days of receiving a COVID-19 vaccination. These symptoms include fatigue, abdominal pain, dizziness or syncope, edema, or cough. OR No symptoms, but abnormal histopathology or a combination of abnormal cardiac biomarkers with abnormal cardiac imaging (echo or MRI) 3. At least one of the following: 1. Elevations in Troponin T, Troponin I, or CK-MB (above threshold of normal) 2. Abnormal MRI (per Brighton Criteria Case Definitions) 3. Any new or worsening cardiac arrhythmias on ECG or telemetry or Holter monitor (per Brighton Criteria Case Definitions) including those that normalize on recovery. 4. Abnormal Echocardiographic findings (per Brighton Criteria Case Definitions, see Appendix 2 and 3) 5. Physical exam finding: Pericardial friction rub or pulsus paradoxus 6. Pericardial fluid or inflammation by imaging (echo, MRI, or CT) or at least one of the following elevated biomarkers of inflammation: ESR, CRP, hs-CRP, or D-Dimer. 7. Enlarged heart on chest radiograph. 8. Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation Exclusion Criteria: 1. Clear alternative diagnosis or explanation for the symptoms and findings (e.g. infectious myocarditis such as Lyme carditis). Note: Work-up of alternative diagnosis is dependent on clinical presentation e.g. Lyme carditis (e.g. endemic area, season, bullseye rash) or autoimmune heart disease (e.g. arthritis, rash, recurrence). 2. Symptoms after 42 days of vaccination.

Primary outcome measure(s)

Proportion of patients with autoimmune disease — 30 days
To identify how many patients (in each group) have a history of autoimmune disease
Composite of MACE — 30 days
To identify major cardiovascular events - death, ventricular arrhythmia, heart block, heart failure, LV dysfunction (LVEF\<55%), cardiac tamponade, re-hospitalization for cardiac reasons

Trial sites (1)

Facility	City	Region	Status
University of Ottawa Heart Institute	Ottawa	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05046002 on ClinicalTrials.gov ↗ ← All trials in Canada