COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry (COVID-VIHPR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05046002|
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : September 16, 2021
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..
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||318 participants|
|Target Follow-Up Duration:||2 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, 2022|
|Estimated Study Completion Date :||August 31, 2023|
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; or syncope.
first-degree family member who also had similar reactions
first-degree family member who has been vaccinated in a similar timeframe with the participants but did not experience myocarditis side-effects.
If a first-degree 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, cardiomyopathy, heart failure
- Relationship between severity, duration of hospitalization, and degrees of organ involvement between those who develop symptoms following one dose versus those following two doses of the mRNA vaccine. [ Time Frame: 3 months ]To assess the relationship between severity, duration of hospitalization, and degrees of organ involvement between those who develop symptoms following one dose versus those following two doses of the mRNA vaccine.
- Relationship between the dosing interval of vaccine and incidence of inflammatory heart disease. [ Time Frame: 30 days ]To assess the relationship between the dosing interval of vaccine and incidence of inflammatory heart disease.
- The potential predictors of severe disease [ Time Frame: 3 months ]To identify predictors as indicated by prolonged hospitalization, evidence of ventricular dysfunction or extensive inflammation will be identified.
- Analysis of immune cell profiles [ Time Frame: 30 days ]Blood samples for those who develop myocarditis/pericarditis vs those who are free from these adverse events, as controls.
Biospecimen Retention: Samples With DNA
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, MDfirstname.lastname@example.org|
|Contact: Ermina Moga||6136967000 ext email@example.com|
|Principal Investigator:||Peter Liu, MD||Ottawa Heart Institute Research Corporation|