COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry (COVID-VIHPR)
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|ClinicalTrials.gov Identifier: NCT05046002|
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : March 15, 2022
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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 three components. First, the vaccine-induced inflammatory heart disease registry will be established. It will include a retrospective cohort study (chart review). Second, patients with persistent symptoms will be invited to participate in additional research-blood work and a 3-month telephone interview, as some of the patients may display chronic symptoms after developing the condition. Third, there will be a prospective, pragmatic design case-control study. We will collect clinical information and include blood samples for biomarkers twice for cases and once for controls and retrospective patients with persistent symptoms. Follow-up telephone interview will be conducted at the 3 months, 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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Target Follow-Up Duration:||4 Years|
|Official Title:||COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry (COVID-VIHPR)|
|Actual Study Start Date :||August 11, 2021|
|Estimated Primary Completion Date :||December 30, 2025|
|Estimated Study Completion Date :||December 31, 2026|
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 Positive)
Family members/relatives who have been vaccinated in a similar timeframe with the participant and had similar reactions
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.
Identified patients, previously diagnosed with the condition, at participating centers
- Proportion of patients with autoimmune disease [ Time Frame: 30 days ]To identify how many patients (in each group) have a history of autoimmune disease
- Composite of MACE [ Time Frame: 30 days ]To identify major cardiovascular events - death, ventricular arrhythmia, heart block, heart failure, LV dysfunction (LVEF<55%), cardiac tamponade, re-hospitalization for cardiac reasons
- Recurrence of myocarditis/pericarditis [ Time Frame: 3 months, 6 months, 12 months, every year for 4 years ]similar symptoms compared to baseline
- Atrial arrhythmias [ Time Frame: 3 months, 6 months, 12 months, every year for 4 years ]irregular atrial heart rhythms
- Cardiovascular mortality [ Time Frame: 3 months, 6 months, 12 months, every year for 4 years ]death from any cardiac cause
- Quality of life data [ Time Frame: 3 months, 6 months, 12 months, every year for 4 years ]EQ-5D-5L questionnaires
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||5 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
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 a positive controls.
- Patients age >= 5 years of age,
- Developed a new 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, palpitations; diaphoresis or sudden death.
OR Developed two new 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 Developed two new symptoms in infants and young children within 42 days of receiving a COVID-19 vaccination. These symptoms include irritability, vomiting, poor feeding, tachypnea, or lethargy.
3. At least one of the following:
a. Elevations in Troponin I, Troponin T or CK-MB (above threshold of normal) c. Abnormal MRI (per Brighton Criteria Case Definitions) d. Any new or worsening cardiac arrhythmias on ECG or telemetry or Holter monitor (per Brighton Criteria Case Definitions), including those that normalize on recovery e. Abnormal echocardiographic findings (per Brighton Criteria Case Definitions) f. Pericardial friction rub or pulsus paradoxus on physical exam g. Pericardial fluid or inflammation by imaging (echo, MRI or CT) h. At least one of the following elevated biomarkers of inflammation: ESR, CRP, hs-CRP or D-Dimer i. Enlarged heart on chest radiograph
1. Clear alternative diagnosis or explanation for the symptoms and findings such as active COVID-19 infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05046002
|Contact: Peter Liu, MDemail@example.com|
|Contact: Ermina Moga||6136967000 ext firstname.lastname@example.org|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y4W7|
|Contact: Tahir Kafil, MD 6136967327 email@example.com|
|Contact: Peter Liu, MD 6136967351 firstname.lastname@example.org|
|Principal Investigator:||Peter Liu, MD||Ottawa Heart Institute Research Corporation|
|Responsible Party:||Ottawa Heart Institute Research Corporation|
|Other Study ID Numbers:||
|First Posted:||September 16, 2021 Key Record Dates|
|Last Update Posted:||March 15, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||To be determined|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|