Design and Rationale of the COVID Vaccine-Associated Myocarditis/Pericarditis (CAMP) Study: Short Title: Design and Rationale of the CAMP Study

Dongngan T Truong; Brian J Harty; Jessica Bainton; Annette Baker; Tamara T Bradford; Bing Cai; Julia Coleman; Cynthia de Luise; Audrey Dionne; Kevin Friedman; Juleen Gayed; Emily Graham; Pei-Ni Jone; Stephan Lanes; Gail D Pearson; Michael A Portman; Andrew J Powell; Mark W Russell; Arash A Sabati; Michael D Taylor; Olivia Wheaton; Jane W Newburger; CAMP Study Investigators (Supplement 1)

doi:10.1016/j.ahj.2024.11.008

Design and Rationale of the COVID Vaccine-Associated Myocarditis/Pericarditis (CAMP) Study: Short Title: Design and Rationale of the CAMP Study

Am Heart J. 2024 Nov 26:S0002-8703(24)00300-4. doi: 10.1016/j.ahj.2024.11.008. Online ahead of print.

Authors

Dongngan T Truong¹, Brian J Harty², Jessica Bainton³, Annette Baker⁴, Tamara T Bradford⁵, Bing Cai⁶, Julia Coleman², Cynthia de Luise⁷, Audrey Dionne⁴, Kevin Friedman⁴, Juleen Gayed⁸, Emily Graham⁶, Pei-Ni Jone⁹, Stephan Lanes¹⁰, Gail D Pearson¹¹, Michael A Portman¹², Andrew J Powell⁴, Mark W Russell¹³, Arash A Sabati¹⁴, Michael D Taylor¹⁵, Olivia Wheaton², Jane W Newburger⁴; CAMP Study Investigators (Supplement 1)

Affiliations

¹ Division of Cardiology, Dept of Pediatrics, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA; currently at Children's Healthcare of Atlanta Cardiology, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: truongd@kidsheart.com.
² Carelon Research, Newton, MA, USA.
³ Division of Cardiology, Dept of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
⁴ Department of Cardiology, Harvard Medical School and Boston Children's Hospital, Boston, MA, USA.
⁵ Division of Cardiology, Dept of Pediatrics, Louisiana State University and Children's Hospital of New Orleans, New Orleans, LA, USA.
⁶ Vaccines Clinical Research and Development, Pfizer, Inc, Collegeville, PA, USA.
⁷ Safety Surveillance Research, Pfizer, Inc, New York, NY, USA.
⁸ Vaccines Clinical Research and Development, Pfizer Ltd, Marlow, UK.
⁹ Pediatric Cardiology, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; currently at Division of Cardiology, Dept of Pediatrics, Northwestern Feinberg School of Medicine and Lurie Children's Hospital, Chicago, IL, USA.
¹⁰ Carelon Research, Wilmington, DE, USA.
¹¹ Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, NIH.
¹² Division of Cardiology, Dept of Pediatrics, University of Washington and Seattle Children's Hospital, Seattle, WA, USA.
¹³ University of Michigan and CS Mott Children's Hospital, Ann Arbor, MI, USA.
¹⁴ Division of Cardiology, Dept of Pediatrics, University of Arizona College of Medicine and Phoenix Children's Hospital, Phoenix, AZ, USA.
¹⁵ Division of Cardiology, Dept of Pediatrics, Dell Medical School and Dell Children's Medical Center, Austin, TX, USA.

PMID: 39608555
DOI: 10.1016/j.ahj.2024.11.008

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.

Keywords: COVID-19 vaccine; myocarditis; pediatrics.