Actively Recruiting
COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry (COVID-VIHPR)
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-01-28
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Myocarditis and pericarditis are inflammatory diseases of the heart muscle and surrounding tissue, which can occur due to various causes including vaccines. This research investigates cases of inflammatory heart disease that developed after receiving COVID-19 vaccines, focusing on symptoms like chest pain and shortness of breath that appear within 2 to 10 days post-vaccination, often after the second dose. The study includes both a retrospective review and a prospective case-control design to better understand this condition. The study has two parts: first, a retrospective chart review to establish a database of patients previously diagnosed with vaccine-related myocarditis or pericarditis. Second, a prospective case-control study will enroll patients who develop symptoms within 42 days of COVID-19 vaccination, along with controls who have been vaccinated but did not develop symptoms. Clinical information and blood samples will be collected at baseline and during a follow-up visit 4 to 12 weeks later, with ongoing telephone interviews at 6 months, 12 months, and yearly up to 4 years. Participants will undergo clinical assessments and blood tests at initial and follow-up visits, and complete quality-of-life questionnaires. Researchers will track serious cardiac events, recurrence of symptoms, arrhythmias, cardiovascular mortality, and overall quality of life over the study period. The long-term follow-up via telephone interviews and record reviews will help monitor the participants' clinical status and health outcomes for up to four years.
CONDITIONS
Brief Title
COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for COVID-19 vaccination
- Experienced at least one cardiac symptom of suspected myocarditis/pericarditis within 42 days of COVID-19 vaccination, such as chest pain, shortness of breath, palpitations, diaphoresis, syncope, or sudden death
- Or experienced at least two non-specific symptoms within 42 days of vaccination, including fatigue, abdominal pain, dizziness, syncope, edema, or cough
- Or no symptoms but abnormal heart tissue findings or combination of abnormal cardiac biomarkers and imaging
- Have at least one abnormal finding among elevated cardiac enzymes, abnormal MRI, new or worsening arrhythmias, abnormal echocardiogram, pericardial friction rub or pulsus paradoxus, pericardial inflammation or fluid, elevated inflammation biomarkers, enlarged heart on chest X-ray, or myocardial inflammation on biopsy
You will not qualify if you...
- Clear alternative diagnosis explaining symptoms, such as infectious myocarditis like Lyme carditis or autoimmune heart disease
- Symptoms starting more than 42 days after COVID-19 vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at Emergency Department, inpatient admission, or Cardiology Outpatient Clinic
Duration - Baseline visit
Participants undergo clinical assessments and bloodwork to evaluate suspected myocarditis or pericarditis related to COVID-19 vaccination.
1 baseline visit (in-person) for clinical assessments and blood sample collection
Duration - Up to 4 years
Participants are followed up to assess clinical status, recurrence of symptoms, cardiovascular outcomes, and quality of life over several years.
1 follow-up visit 4 to 12 weeks after baseline, then telephone interviews at 6 months, 12 months, and annually up to 4 years
Trial Site Locations
Total: 1 location
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Actively Recruiting
Research Team
P
Peter Liu, MD
E
Ermina Moga
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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