COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    318
  • sponsor
    Ottawa Heart Institute Research Corporation
Updated on 23 September 2021
chest pain
heart disease
covid-19

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.

In the past months, doctors have noticed more people presenting to the Emergency Department with chest pain and shortness of breath after receiving a COVID-19 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. First, the vaccine-induced inflammatory heart disease registry will be established It will include a retrospective cohort study and a prospective, pragmatic design case-control study. We will collect clinical information and include blood samples for biomarkers at the baseline/recruitment visit and first follow-up visit. Follow-up telephone interview will be conducted at the 3-month and record search at 6m, 12m and yearly up to 10 years..

Description

The study will consist of three components. First, the vaccine-induced inflammatory heart disease registry will be established. This will include a retrospective chart review in collaboration with Ottawa Public Health and the Ontario Data Platform (OHDP). Second, we will invite patients with persistent symptoms, identified in the retrospective chart review, to participate in research bloodwork and a 3-month telephone interview. Third, there will be a prospective, pragmatic design case-control study. We will not have a standardized management protocol.

This will be a multi-centre study conducted in tertiary centres in Ontario treating post-vaccine inflammatory heart disease in both the inpatient and outpatient setting. The study will commence at UOHI and The Ottawa Hospital, but expected to rapidly obtain additional sites. In Ontario, the major hospitals will include CHEO, London, Toronto, Hamilton, and Kingston.

Patients will be invited to participate in the Registry when they present to the Emergency Department, during inpatient admission, or in the Cardiology Outpatient Clinic, either by being approached by a research coordinator or by being provided contact information to call if they are interested. Patients will be invited to ask their first-degree relatives to contact the research site to serve as controls. The retrospective component of the study will be conducted by identifying patients previously diagnosed with this condition at participating centres.

We will collect clinical information and include blood samples for biomarkers at the baseline/recruitment visit and first follow-up visit. The timing of the follow-up visit is limited by availability of clinic appointment times but expected to be between 2 and 6 weeks after the initial visit. The research blood samples will be stored and processed at the Ottawa Heart Institute. They will be stored for future research in Dr. Peter Liu's Cardiac Function laboratory.

The patients will be followed up in a rapid assessment clinic dedicated to patients with vaccine-induced inflammatory heart disease. Patients at other sites will be followed-up by their respective local site-PIs and bloodwork will be arranged to be sent to the UOHI. Outpatient standard of care clinical cMRI is being expedited by the MRI department for local patients. If an MRI is abnormal, a repeat cardiac MRI will be completed for routine clinical care follow-up.

The UOHI will see the patients for clinical purposes and the research data will be captured at the same time points. These are expected at baseline/initial visit and then a 2-6 week follow-up visit. Clinical assessments, and bloodwork will be conducted at the two visits. Subsequent follow-up via telephone interview will be conducted at the 3-month mark with a script-based questionnaire to ascertain the patient's clinical status and the achievement of clinical endpoints.

In the event the patient is admitted to the hospital, follow-ups can be completed by a medical record search. Chart reviews will be conducted at 180 days (6 months) and 365 days (1 year) and then annually for up to 10 years.

Details
Condition Heart disease, Pericarditis, Cardiomyopathy, Myocarditis
Clinical Study IdentifierNCT05046002
SponsorOttawa Heart Institute Research Corporation
Last Modified on23 September 2021

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