Registry for heart inflammation after COVID-19 vaccination

COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry (COVID-VIHPR)

This study is trying to collect information about heart inflammation cases, like myocarditis and pericarditis, that might happen after COVID-19 vaccination to better understand how it affects patients.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT05046002 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a registry for cases of myocarditis and pericarditis that may occur following COVID-19 vaccination. It will involve a retrospective chart review of patients diagnosed with these conditions and a prospective case-control study to gather clinical data and biomarkers. The study will be conducted at multiple centers in Canada, focusing on patients presenting with symptoms related to inflammatory heart disease after vaccination. Participants will be recruited from emergency departments, inpatient admissions, and outpatient cardiology clinics.

Who should consider this trial

Good fit: Ideal candidates include individuals who have received a COVID-19 vaccine and are experiencing cardiac symptoms or have abnormal cardiac biomarkers within 42 days post-vaccination.

Not a fit: Patients who have not received a COVID-19 vaccine or do not exhibit any cardiac symptoms or abnormalities are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the prevalence and risk factors of vaccine-induced inflammatory heart disease, improving patient safety and vaccine protocols.

How similar studies have performed: While there have been reports of myocarditis and pericarditis following COVID-19 vaccination, this specific registry approach is novel and aims to systematically document these cases.

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.

Where this trial is running

Ottawa, Ontario

• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Peter Liu, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Peter Liu, MD

Conditions Myocarditis; Pericarditis