Truong Dongngan T, Harty Brian J, Bainton Jessica, Baker Annette, Bradford Tamara T, Cai Bing, Coleman Julia, de Luise Cynthia, Dionne Audrey, Friedman Kevin, Gayed Juleen, Graham Emily, Jone Pei-Ni, Lanes Stephan, Pearson Gail D, Portman Michael A, Powell Andrew J, Russell Mark W, Sabati Arash A, Taylor Michael D, Wheaton Olivia, Newburger Jane W
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.
Carelon Research, Newton, MA.
Am Heart J. 2025 Mar;281:32-42. doi: 10.1016/j.ahj.2024.11.008. Epub 2024 Nov 26.
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.
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.
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.
关于新冠病毒疫苗相关心肌炎/心包炎的中长期结局的数据极少。新冠疫苗相关心肌炎/心包炎（CAMP）研究旨在描述接种任何辉瑞-生物科技公司新冠病毒疫苗（以下简称COMIRNATY®）后心肌炎/心包炎的中长期后遗症。在此，我们描述CAMP研究的基本原理和设计。
这项正在进行且正在积极招募患者的多中心观察性队列研究，涉及北美32个儿科心脏中心，将纳入至少200名年龄<21岁的患者，这些患者在接种COMIRNATY®疫苗后≤21天出现症状，且符合美国疾病控制与预防中心（CDC）可能或确诊心肌炎/心包炎或孤立性心包炎的病例定义。对照组将由100名年龄<21岁的新冠病毒相关心肌炎/心包炎患者组成，包括那些符合同期CDC多系统炎症综合征（MIS-C）病例定义的患者。该研究将收集发病后长达5年的详细住院和随访数据。心电图、超声心动图和心脏磁共振（CMR）检查将在核心实验室进行解读。主要结局包括：1）心肌炎/心包炎发病6个月时，超声心动图显示左心室射血分数<55%、CMR根据原始或修订的路易斯湖标准显示心肌炎表现和/或存在高级别心律失常或传导系统障碍的综合情况；2）并发症，如死亡和非心脏疾病；3）患者报告的整体健康、功能状态和生活质量结局。分析将包括描述性统计和回归建模。
仍在招募患者，截至2024年10月16日，已有273名参与者入组（173名疫苗相关心肌炎/心包炎患者，100名新冠病毒相关心肌炎/心包炎患者）
通过长期随访以及核心实验室对心脏检查进行标准化评估，CAMP研究将为我们了解新冠病毒疫苗相关心肌炎/心包炎的中长期心脏和非心脏后遗症做出重要贡献。
