NCT05046002 COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry
| NCT ID | NCT05046002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Myocarditis |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-08-11 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2021-08-11 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Peter Liu, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT05046002 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Myocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05046002 currently recruiting?
Yes, NCT05046002 is actively recruiting participants. Contact the research team at pliu@ottawaheart.ca for enrollment information.
Where is the NCT05046002 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT05046002 clinical trial?
NCT05046002 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Peter Liu, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 400 participants.