AI Article Synopsis

  • The CAMP study is an ongoing research project aiming to assess the mid- and long-term effects of myocarditis and pericarditis following the Pfizer-BioNTech COVID-19 vaccine in patients under 21.
  • It involves a cohort of at least 200 vaccinated patients and a comparison group of 100 patients with COVID-19 related myocarditis, collecting data over a 5-year span to track health outcomes and complications.
  • As of October 16, 2024, the study has enrolled 273 participants, focusing on heart function, complications, and overall quality of life post-illness.

Article Abstract

Background: Minimal data are available on mid- and long-term outcomes following COVID-19 vaccine-associated myocarditis/pericarditis. The COVID Vaccine-Associated Myocarditis/Pericarditis (CAMP) study aims to characterize the mid- and long-term sequelae of myocarditis/pericarditis following administration of any Pfizer-BioNTech COVID-19 vaccine (herein referred to as COMIRNATY®). Herein we describe the rationale and design of CAMP.

Methods: This ongoing and actively enrolling multicenter observational cohort study across 32 North American pediatric cardiac centers will include at least 200 patients <21 years-old who presented ≤21 days from COMIRNATY® vaccination and meet the Centers for Disease Control and Prevention (CDC) case definition of probable or confirmed myocarditis/pericarditis or isolated pericarditis. The comparison cohort will consist of 100 patients <21 years-old with COVID-19 associated myocarditis/pericarditis, including those who meet the contemporaneous CDC case definition of multisystem inflammatory syndrome (MIS-C). The study will collect detailed hospital and follow-up data for up to 5 years following illness onset. Electrocardiograms, echocardiograms, and cardiac magnetic resonance (CMR) examinations will be interpreted in core laboratories. The primary outcomes are 1) composite of left ventricular ejection fraction <55% by echocardiogram, findings of myocarditis by original or revised Lake Louise criteria on CMR, and/or the presence of high-grade arrhythmias or conduction system disturbances at 6 months after myocarditis/pericarditis onset; 2) complications, such as death, and non-cardiac morbidities; and 3) patient-reported outcomes of global health, functional status, and quality of life. Analyses will include descriptive statistics and regression modeling.

Current Status: Still enrolling, with 273 participants currently enrolled as of 10/16/2024 (173 vaccine-associated myocarditis/pericarditis, 100 COVID-19-associated myocarditis/pericarditis) CONCLUSIONS: With long-term follow-up and core laboratories for standardized assessments of cardiac testing, the CAMP study will make important contributions to our understanding of the mid- and long-term cardiac and non-cardiac sequelae of COVID-19 vaccine-associated myocarditis/pericarditis.

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http://dx.doi.org/10.1016/j.ahj.2024.11.008DOI Listing

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Article Synopsis
  • The CAMP study is an ongoing research project aiming to assess the mid- and long-term effects of myocarditis and pericarditis following the Pfizer-BioNTech COVID-19 vaccine in patients under 21.
  • It involves a cohort of at least 200 vaccinated patients and a comparison group of 100 patients with COVID-19 related myocarditis, collecting data over a 5-year span to track health outcomes and complications.
  • As of October 16, 2024, the study has enrolled 273 participants, focusing on heart function, complications, and overall quality of life post-illness.
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Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.

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Background: Limited information exists to guide shared clinical decision making on COVID-19 vaccination in persons with a prior history of vaccine-associated myocarditis, pericarditis, or myopericarditis (VAMP). The objective of this retrospective observational case series was to characterize cardiac outcomes within 30 days following receipt of 1 or more COVID-19 vaccinations during 2021 in US service members diagnosed with prior non-COVID-19 VAMP between 1998 and 2019.

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