Low-Interventional Cohort Study of Myocarditis/Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age
R
R. Mark Payne, MD
Primary Investigator
Enrolling By Invitation
21 years and younger
All
Phase
N/A
4 participants needed
1 Location
Brief description of study
The main reason for this research study is to learn more about myocarditis and pericarditis (called myocarditis in this document) following vaccination with the Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY). Myocarditis is inflammation of the muscle of the heart, and pericarditis is inflammation of the tissue that forms a sac around the heart.
Detailed description of study
Participants will be asked to allow researchers to collect information about routine heart tests doctors have performed. If doctors have not ordered these tests, the researchers may ask the participant for permission to do these tests. The participant or guardian will be asked to fill out questionnaires about symptoms. Researchers will reach out to participants once a year to learn about the participant's health.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: myocarditis, pericarditis, Riley
-
Age: - 21 Years
-
Gender: All
Inclusion Criteria:
- Presentation to a participating medical center with evaluation in Emergency Room and/or hospitalization
- Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY ≤7 days of symptom onset, even if a different brand of COVID-19 vaccine had been administered in earlier vaccinations Retrospectively ascertained participants must be enrolled within 2 years of diagnosis
- Probable or confirmed myocarditis/pericarditis as per the contemporaneous CDC case definition at the time of diagnosis
- Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients) Consent/Assent Document and in this protocol OR meets criteria for waiver of consent
Exclusion Criteria:
- A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis
- Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of:
- Bicommissural aortic valve with < trivial stenosis and/or insufficiency
- Mitral valve prolapse with ≤ trivial insufficiency
- Hemodynamically insignificant atrial septal or ventricular septal defects
- Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement)
Updated on
13 Sep 2024.
Study ID: 16384, PCTR-HEALTHCORE-CAMP
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