COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

Phase

N/A

Condition

Chest Pain

Dermatomyositis (Connective Tissue Disease)

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT05046002

CTO 3740

Ages > 5
All Genders
Accepts Healthy Volunteers

Study 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).

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

Inclusion

Inclusion Criteria:

All patients eligible for vaccination with a COVID-19 vaccine,
At least one cardiac symptom of suspected myocarditis/pericarditis within 42 days ofreceiving 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-19vaccination. These symptoms include fatigue, abdominal pain, dizziness or syncope,edema, or cough. OR No symptoms, but abnormal histopathology or a combination of abnormal cardiacbiomarkers 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 onrecovery.
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 oneof the following elevated biomarkers of inflammation: ESR, CRP, hs-CRP, orD-Dimer.
Enlarged heart on chest radiograph.
Histopathologic examination of myocardial tissue (autopsy or endomyocardialbiopsy) showed myocardial inflammation

Exclusion

Exclusion Criteria:

Clear alternative diagnosis or explanation for the symptoms and findings (e.g.infectious myocarditis such as Lyme carditis). Note: Work-up of alternativediagnosis is dependent on clinical presentation e.g. Lyme carditis (e.g. endemicarea, season, bullseye rash) or autoimmune heart disease (e.g. arthritis, rash,recurrence).
Symptoms after 42 days of vaccination.

Study Design

August 11, 2021

December 31, 2026

Study Description

There will be a prospective, pragmatic design case-control study for vaccine myocarditis/pericarditis.

This will be a multi-center study conducted in centers in Canada that treat post-vaccine inflammatory heart disease in both the inpatient and outpatient settings. 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. Patients will be invited to ask a relative or friend 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 centers.

At some centers, we will collect clinical information and include blood samples for biomarkers at the baseline/recruitment visit and first follow-up visit for cases and at a research study visit for controls. The follow-up visit is expected to be between 4 and 12 weeks after the initial visit.

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 4-12-weeks follow-up visit. Clinical assessments and bloodwork will be conducted at the two visits. Subsequent follow-up via telephone interview will be conducted after 6 months, 12 months and every year for 4 years, with a script-based questionnaire to ascertain the patient's clinical status and the achievement of clinical endpoints. Patients will be asked to complete a quality-of-life questionnaire.

Connect with a study center

University of Ottawa Heart Institute
Ottawa, Ontario K1Y4W7
Canada
Site Not Available
University of Ottawa Heart Institute
Ottawa 6094817, Ontario 6093943 K1Y4W7
Canada
Active - Recruiting

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