COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorOttawa Heart Institute Research Corporation
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
All patients eligible for vaccination with a COVID-19 vaccine,
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.
Elevations in Troponin T, Troponin I, or CK-MB (above threshold of normal)
Abnormal MRI (per Brighton Criteria Case Definitions)
Disqualifiers
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).
Symptoms after 42 days of vaccination.
Trial population
Patients who have developed symptoms after receiving a COVID-19 vaccine and meet the inclusion and exclusion criteria are eligible to participate in the registry. Family members, vaccinated in a similar timeframe, with similar technology vaccine (e.g. any mRNA) but did not experience myocarditis side-effects - as a negative controls. If a relative is not available, voluntary controls who received the same type of COVID-19 vaccine in a similar time frame can be recruited (friends, roommates) Alternatively, if family members also had similar reactions, they can be recruited as positive controls. For the retrospective registry, we would also collect data on COVID-19 myocarditis and pericarditis and all other etiologies of myocarditis or pericarditis.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 3 trial groupsGroup A: Prospective (cases)
Group B: Prospective (Control Negative)
Group C: Retrospective
Trial outcomes
Primary outcomes
1
Proportion of patients with autoimmune disease
To identify how many patients (in each group) have a history of autoimmune disease
Time frame
30 days2
Composite of MACE
To identify major cardiovascular events - death, ventricular arrhythmia, heart block, heart failure, LV dysfunction (LVEF\<55%), cardiac tamponade, re-hospitalization for cardiac reasons
Time frame
30 daysSecondary outcomes
1
Recurrence of myocarditis/pericarditis
similar symptoms compared to baseline
Time frame
3 months, 6 months, 12 months, every year for 4 years2
Atrial arrhythmias
irregular atrial heart rhythms
Time frame
3 months, 6 months, 12 months, every year for 4 years3
Cardiovascular mortality
death from any cardiac cause
Time frame
3 months, 6 months, 12 months, every year for 4 years4
Quality of life data
EQ-5D-5L questionnaires
Time frame
3 months, 6 months, 12 months, every year for 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov