Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.

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
Myocarditis Pericarditis

Detailed Description:

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 318 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Research Prospective
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.
Control Positive
first-degree family member who also had similar reactions
Control Negative

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.

Research Retrospective
identified patients previously diagnosed with the condition, at participating centers



Primary Outcome Measures :
  1. Proportion of patients with autoimmune disease [ Time Frame: 30 days ]
    To identify how many patients (in each group) have a history of autoimmune disease

  2. Composite of MACE [ Time Frame: 30 days ]
    To identify major cardiovascular events - death, ventricular arrhythmia, heart block, cardiomyopathy, heart failure

  3. 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.

  4. 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.

  5. 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.

  6. 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
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

First-degree 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 first-degree relative are not available, voluntary controls who received the same type of COVID-19 vaccine in a similar time frame can be recruited.

Alternatively, if first-degree family members also had similar reactions, they can be recruited as a positive controls.

Criteria

Inclusion Criteria:

  1. Patients age >= 12 years of age,
  2. 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, or pain with breathing; palpitations; or syncope.

    OR Developed two new non-specific symptoms in patients 12-18 years of age 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:

    1. ECG abnormalities
    2. Elevations in any type of troponin (above threshold of normal)
    3. MRI evidence of abnormal T1 or T2 values compatible with myocarditis, as recommended by the updated Lake Louise criteria, or pericarditis, or pericardial effusion
    4. Any new or worsening cardiac arrhythmias on ECG or telemetry or Holter monitor
    5. Echocardiographic findings of abnormal cardiac function, new wall motion abnormality, or pericardial effusion
    6. Pericardial friction rub on physical exam

Exclusion Criteria:

1. Clear alternative diagnosis or explanation for the symptoms and findings such as active COVID-19 infection.


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Peter Liu, MD 6136967351 pliu@ottawaheart.ca
Contact: Ermina Moga 6136967000 ext 10945 emoga@ottawaheart.ca

Locations
Layout table for location information
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Tahir Kafil, MD    6136967327    tkafil@ottawaheart.ca   
Contact: Peter Liu, MD    6136967351    pliu@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Layout table for investigator information
Principal Investigator: Peter Liu, MD Ottawa Heart Institute Research Corporation
Layout table for additonal information
Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05046002    
Other Study ID Numbers: CTO 3740
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Myocarditis
Pericarditis
Cardiovascular Diseases
Cardiomyopathies