COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

NCT05046002 | Recruiting

• 1 other identifier: CTO 3740
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocarditis; Pericarditis

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with autoimmune disease

  To identify how many patients (in each group) have a history of autoimmune disease

  30 days

• 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

  30 days

Secondary Outcomes (4)

• Recurrence of myocarditis/pericarditis

  3 months, 6 months, 12 months, every year for 4 years

• Atrial arrhythmias

  3 months, 6 months, 12 months, every year for 4 years

• Cardiovascular mortality

  3 months, 6 months, 12 months, every year for 4 years

• Quality of life data

  3 months, 6 months, 12 months, every year for 4 years

Study Arms (3)

Prospective (cases)

Patients who develop new symptoms 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, or pain with breathing; palpitations; diaphoresis or sudden death. The symptoms can also be non-specific, including fatigue, abdominal pain, dizziness or syncope, edema, cough or irritability, vomiting, poor feeding, tachypnea or lethargy in young children

Prospective (Control Negative)

Family members/relatives who have been vaccinated in a similar timeframe with the participants but did not experience myocarditis side-effects. If a relative is not available, then a voluntary control who has received the same COVID-19 vaccine in a similar time frame can be recruited.

Retrospective

Identified patients, previously diagnosed with the condition, at participating centers

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.
• 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)
• At least one of the following:
• Elevations in Troponin T, Troponin I, or CK-MB (above threshold of normal)
• Abnormal MRI (per Brighton Criteria Case Definitions)
• Any new or worsening cardiac arrhythmias on ECG or telemetry or Holter monitor (per Brighton Criteria Case Definitions) including those that normalize on recovery.
• Abnormal Echocardiographic findings (per Brighton Criteria Case Definitions, see Appendix 2 and 3)
• Physical exam finding: Pericardial friction rub or pulsus paradoxus
• 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.
• Enlarged heart on chest radiograph.
• Histopathologic examination of myocardial tissue (autopsy or endomyocardial biopsy) showed myocardial inflammation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

At the time of standard-of-care bloodwork collection, additional research blood samples for biomarker assessment will be collected. Analysis of serum biomarkers such as hs-CRP, ESR, TNF-alpha, IL-1 beta IL-6, and IL-10 may help shed light on the pathway of inflammation. Antibody titres response to mRNA vaccination in younger patients will be of particular interest.

MeSH Terms

Conditions

Myocarditis; Pericarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Peter Liu, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Liu, MD

CONTACT

6136967351; pliu@ottawaheart.ca

Ermina Moga

CONTACT

6136967000; emoga@ottawaheart.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: September 16, 2021
• Study Start: August 11, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CA (1)