Design and rationale of the COVID vaccine-associated myocarditis/pericarditis (CAMP) study
Study context
- Population
- Patients <21 years with myocarditis/pericarditis after Pfizer-BioNTech COVID-19 vaccine (COMIRNATY®), North American pediatric cardiac centersenrolled as of 10/16/2024
- Participants
- 273 patients
- Planned comparison
- COVID-19 vaccine-associated myocarditis/pericarditis vs COVID-19-associated myocarditis/pericarditis
- Vaccine-associated myocarditis/pericarditisn = 173
- COVID-19-associated myocarditis/pericarditisn = 100reference
- Primary endpoint
- 1) Composite of LVEF <55% by echocardiogram, myocarditis by original or revised Lake Louise criteria on cardiac magnetic resonance (CMR), and/or high-grade arrhythmias or conduction system disturbances; 2) complications, such as death, and non-cardiac morbidities; 3) patient-reported global health, functional status and quality of life
- Follow-up
- 6 months after myocarditis/pericarditis onset (composite)
Methodological detailsmulticentre, 32 North American pediatric cardiac centers, ongoing, actively enrolling, core laboratories, Follow-up up to 5 years after illness onset, Analyses: descriptive statistics and regression modeling
- Multicentre
- 32 North American pediatric cardiac centers
- Ongoing, actively enrolling
- Core laboratories
- Follow-up up to 5 years after illness onset
- Analyses: descriptive statistics and regression modeling
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Design and rationale of the COVID vaccine-associated myocarditis/pericarditis (CAMP) study. Am Heart J. Published 26 November 2024. doi:10.
Summarised from the published abstract; every number is checked against it