Status:
RECRUITING
COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Myocarditis
Pericarditis
Eligibility:
All Genders
5+ years
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 he...
Detailed Description
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/peri...
Eligibility Criteria
Inclusion Criteria:
-
All patients eligible for vaccination with a COVID-19 vaccine,
-
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)
-
At least one of the following:
- Elevations in Troponin T, Troponin I, or CK-MB (above threshold of normal)
- Abnormal MRI (per Brighton Criteria Case Definitions)
- Any new or worsening cardiac arrhythmias on ECG or telemetry or Holter monitor (per Brighton Criteria Case Definitions) including those that normalize on recovery.
- Abnormal Echocardiographic findings (per Brighton Criteria Case Definitions, see Appendix 2 and 3)
- Physical exam finding: Pericardial friction rub or pulsus paradoxus
- 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.
- Enlarged heart on chest radiograph.
- Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation
Exclusion Criteria:
- 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).
- Symptoms after 42 days of vaccination.
Key Trial Info
Start Date :
August 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05046002
Start Date
August 11 2021
End Date
December 31 2026
Last Update
January 28 2026
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7