The NHLBI Study on Long-terM OUtcomes after the Multisystem Inflammatory Syndrome In Children (MUSIC): Design and Objectives

• Type of Material: Article
• Authors: Dongngan T Truong, University of Utah; Felicia L Trachtenberg, RTI International, Research Triangle Park; Gail D Pearson, NHLBI; Audrey Dionne, Harvard Medical School; Matthew D Sánchez, Childrens Hospital of Philadelphia; Kevin Friedman, Harvard Medical School; Kerri H Hayes, HealthCore; Lynn Mahony, Univ Texas Southwestern Med Ctr Dallas; Brian W McCrindle, University of Toronto; Matthew Oster, Emory University; Victoria Pemberton, National Heart, Lung, and Blood Institute/NIH; Andrew J Powell, Harvard Medical School; Mark W Russell, University of Michigan; Lara S Shekerdemian, Baylor College of Medicine; Mary Beth Son, Harvard Medical School; Michael Taylor, Emory University; Jane W Newburger, Harvard Medical School
• Language: English
• Date: 2021-10-19
• Publisher: MOSBY-ELSEVIER
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2021 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.ahj.2021.08.003
• Title of Journal or Parent Work: AMERICAN HEART JOURNAL
• Volume: 243
• Start Page: 43
• End Page: 53
• Keywords: Cardiac & Cardiovascular Systems; CORONARY-ARTERY DILATION; Cardiovascular System & Cardiology; Life Sciences & Biomedicine; COVID-19; DISEASE; Science & Technology

Abstract

Background: The Long-terM OUtcomes after the Multisystem Inflammatory Syndrome In Children (MUSIC) study aims to characterize the frequency and time course of acute and long-term cardiac and non-cardiac sequelae in multisystem inflammatory syndrome in children associated with COVID-19 (MIS-C), which are currently poorly understood. Methods: This multicenter observational cohort study will enroll at least 600 patients <21 years old who meet the Centers for Disease Control and Prevention case definition of MIS-C across multiple North American centers over 2 years. The study will collect detailed hospital and follow-up data for up to 5 years, and optional genetic testing. Cardiac imaging at specific time points includes standardized echocardiographic assessment (all participants) and cardiac magnetic resonance imaging (CMR) in those with left ventricular ejection fraction (LVEF) <45% during the acute illness. The primary outcomes are the worst LVEF and the highest coronary artery z-score of the left anterior descending or right coronary artery. Other outcomes include occurrence and course of non-cardiac organ dysfunction, inflammation, and major medical events. Independent adjudication of cases will classify participants as definite, possible, or not MIS-C. Analysis of the outcomes will include descriptive statistics and regression analysis with stratification by definite or possible MIS-C. The MUSIC study will provide phenotypic data to support basic and translational research studies. Conclusion: The MUSIC study, with the largest cohort of MIS-C patients and the longest follow-up period to date, will make an important contribution to our understanding of the acute cardiac and non-cardiac manifestations of MIS-C and the long-term effects of this public health emergency.