COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Sep 14, 2021

Keywords

ClinConnect Summary

The COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry is a clinical trial aimed at understanding how often some people develop heart inflammation, specifically myocarditis and pericarditis, after receiving a COVID-19 vaccine. These conditions involve swelling of the heart muscle and the tissue surrounding it, which can cause symptoms like chest pain and shortness of breath. The study is looking into cases where individuals have experienced these symptoms within 42 days of vaccination, especially after the second dose. It will involve reviewing past patient records and conducting follow-up interviews over several years to gather more information.

To be eligible for this study, participants need to be at least 18 years old and have experienced specific cardiac symptoms or abnormal test results within 42 days after getting vaccinated. This could include chest pain, shortness of breath, or findings from heart tests that indicate inflammation. Participants will provide important data that could help doctors understand the relationship between COVID-19 vaccines and heart health. If you or someone you know has had these experiences after vaccination, this study could be a valuable opportunity to contribute to important medical research.

Gender

ALL

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.