RecruitingNCT05046002

COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

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


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

400 participants

Start Date

Aug 11, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This registry study tracks patients who develop heart inflammation (myocarditis or pericarditis) after receiving a COVID-19 vaccine. The goal is to understand how common this is, who is most at risk, and what the outcomes are over time. You may be eligible if: - You received a COVID-19 vaccine - Within 42 days of vaccination, you developed cardiac symptoms (chest pain, shortness of breath, palpitations, fainting) or at least two non-specific symptoms (fatigue, dizziness, swelling, cough), OR had abnormal cardiac lab or imaging results - You also have at least one objective sign of cardiac involvement (e.g., elevated troponin, abnormal ECG, abnormal echo or MRI) - You are 5 years of age or older You may NOT be eligible if: - There is another clear explanation for your cardiac symptoms (e.g., confirmed Lyme carditis or other infectious cause) - Your symptoms started more than 42 days after your vaccination Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

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NCT05046002


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