Dongngan T Truong1, Felicia L Trachtenberg2, Gail D Pearson3, Audrey Dionne4, Matthew D Elias5, Kevin Friedman4, Kerri H Hayes2, Lynn Mahony6, Brian W McCrindle7, Matthew E Oster8, Victoria Pemberton3, Andrew J Powell4, Mark W Russell9, Lara S Shekerdemian10, Mary Beth Son4, Michael Taylor11, Jane W Newburger4. 1. Department of Pediatrics, Dvision of Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA. Electronic address: Dongngan.truong@hsc.utah.edu. 2. HealthCore, Watertown, MA, USA. 3. National Heart, Lung, and Blood Institute/NIH, Bethesda, MD, USA. 4. Department of Cardiology, Boston Children's Hospital and Department of Pediatrics, Harvard Medical School, Boston, MA, USA. 5. Division of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA. 6. Division of Cardiology, Department of Pediatrics, University of Texas Southwestern Medical Center at Dallas, TX, USA. 7. The Division of Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. 8. Children's Heart Center, Department of Pediatrics, Children's Healthcare of Atlanta, Emory Unviersity School of Medicine, Atlanta, GA, USA. 9. Division of Pediatric Cardiology, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA. 10. Division of Critical Care, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA. 11. The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
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.
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.
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