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The NHLBI Study on Long-ter Otcomes after the Multisystem nflammatory yndrome n hildren (MUSIC): Design and Objectives - 26/11/21

Doi : 10.1016/j.ahj.2021.08.003 
Dongngan T. Truong, MD, MS a, , Felicia L. Trachtenberg, PhD b, Gail D. Pearson, MD c, Audrey Dionne, MD d, Matthew D. Elias, MD e, Kevin Friedman, MD d, Kerri H. Hayes b, Lynn Mahony, MD f, Brian W. McCrindle, MD, MPH g, Matthew E. Oster, MD, MPH h, Victoria Pemberton, RNC, MS c, Andrew J. Powell, MD d, Mark W. Russell, MD i, Lara S. Shekerdemian, MD j, Mary Beth Son, MD d, Michael Taylor, MD k, Jane W. Newburger, MD, MPH d

for the MUSIC Study Investigators (Supplement 1)

Audrey Dionne, MD 1, #, Matthew D. Elias, MD 2, #, Therese M. Giglia, MD 2, #, Kimberly E. McHugh, MD, MSCR 3, #, Andrew M. Atz, MD 3, #, Scott A. Pletzer, MD 3, #, Dongngan T. Truong, MD, MSCI 4, #, Mark W. Russell, MD 5, #, Sean M. Lang, MD 6, #, R. Mark Payne, MD 7, #, Jyoti K. Patel, MD 7, #, Matthew E. Oster, MD, MPH 8, Lara S. Shekerdemian, MB ChB, MD, MHA 8, #, Ricardo H. Pignatelli, MD 8, #, Kristen Sexson, MD, PhD 8, #, Brian W. McCrindle, MD 9, #, Christopher Lam, MD 9, #, Andreea Dragulescu, MD 9, #, Rae SM Young, MD, PhD 9, #, Beth Gamulka, MD 9, #, Anita Krishnan, MD 10, Brett R. Anderson, MD, MBA, MS 11, Kanwal M. Farooqi, MD 11, Divya Shakti, MBBS, MPH 12, Aimee S. Parnell, MD, MSCE 12, Onyekachukwu J Osakwe 12, Michelle C. Sykes, MD, PhD 13, Lerraughn Morgan, DO 13, Carl Y. Owada, MD 13, Daniel Forsha, MD, MHS 14, Michael R. Carr, MD 15, Kae Watanabe, MD 15, Michael A. Portman, MD 16, Kristen B. Dummer, MD 17, Jane C. Burns, MD 17, Adriana H. Tremoulet, MD, MAS 17, Kavita Sharma, MD 18, Pei-Ni Jone, MD 19, Michelle Hite Heather Heizer, PA-C 19, Keren Hasbani, MD 20, Shubhika Srivastava, MD 21, Elizabeth C Mitchell, MD 22, Camden L. Hebson, MD 23, Jacqueline R. Szmuszkovicz, MD 24, Pierre C. Wong, MD 24, Andrew L. Cheng, MD 24, Jodie K. Votava-Smith, MD 24, Shuo Wang, MD 24, Sindhu Mohandas, MD 24, Gautam K. Singh, MD, MRCP 25, Sanjeev Aggarwal, MD 25, Yamuna Sanil, MD 25, Tamara T. Bradford, MD 26, Juan Carlos G. Muniz, MD 27, Jennifer S. Li, MD, MHS 28, Michael Jay Campbell, MD, MHA 28, Stephanie S. Handler, MD 29, J Ryan Shea, MD 30, Timothy M. Hoffman, MD 30, Wayne J. Franklin, MD 31, Arash A. Sabati, MD 31, Todd T. Nowlen, MD 31, Maryanne Chrisant, MD 32
1 Boston Children's Hospital, Harvard Medical School, Boston, MA 
2 Division of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, PA 
3 Medical University of South Carolina, Charleston, SC 
4 University of Utah/Primary Children's Hospital, Salt Lake City, UT 
5 University of Michigan, Ann Arbor, MI 
6 The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 
7 Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN 
8 Children's Healthcare of Atlanta*, Emory University School of Medicine, Atlanta, GA 
8 Baylor College of Medicine, Texas Children's Hospital, Houston, TX 
9 The Hospital for Sick Children#, University of Toronto, Toronto, Canada 
10 Children's National Hospital, Washington DC 
11 New York-Presbyterian/Columbia University Irving Medical Center, New York, NY 
12 University of Mississippi Medical Center, Jackson, MS 
13 Valley Children's Hospital, Madera, CA 
14 Children's Mercy Kansas City, University of Kansas Medical Center, Kansas City, MO 
15 Ann & Robert Lurie Children's Hospital of Chicago, Chicago, IL 
16 Seattle Children's Hospital, Seattle, WA 
17 Department of Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, CA 
18 UT Southwestern Medical Center; Dallas, TX 
19 Children's Hospital of Colorado, University of Colorado Anschutz Medical Campus, Denver, CO 
20 Dell Children's Medical Center, Austin, TX 
21 Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE 
22 Cohen Children's Medical Center (Northwell Health), Queens, NY 
23 University of Alabama at Birmingham/Children's of Alabama, Birmingham, AL 
24 Children's Hospital Los Angeles, Los Angeles, CA 
25 Central Michigan University/Children's Hospital of Michigan, Detroit, MI 
26 Children's Hospital of New Orleans-LSU Health Sciences Center, New Orleans, LA 
27 Nicklaus Children's Hospital, Miami, FL 
28 Duke University, Durham, NC 
29 Medical College of Wisconsin, Department of Pediatrics, Division of Cardiology, Milwaukee, WI 
30 University of North Carolina at Chapel Hill, Chapel Hill, NC 
31 Phoenix Children's Hospital, Phoenix, AZ 
32 Joe DiMaggio Children's Hospital, Hollywood, FL 

a Department of Pediatrics, Dvision of Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA 
b HealthCore, Watertown, MA, USA 
c National Heart, Lung, and Blood Institute/NIH, Bethesda, MD, USA 
d Department of Cardiology, Boston Children's Hospital and Department of Pediatrics, Harvard Medical School, Boston, MA, USA 
e Division of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA 
f Division of Cardiology, Department of Pediatrics, University of Texas Southwestern Medical Center at Dallas, TX, USA 
g The Division of Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada 
h Children's Heart Center, Department of Pediatrics, Children's Healthcare of Atlanta, Emory Unviersity School of Medicine, Atlanta, GA, USA 
i Division of Pediatric Cardiology, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA 
j Division of Critical Care, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA 
k The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA 

Reprint requests: Dongngan T. Truong, MD, MS, University of Utah and Primary Children's Hospital, 81 North Mario Capecchi Drive, Salt Lake City, UT, 84113University of Utah and Primary Children's Hospital81 North Mario Capecchi Drive, Salt Lake CityUT84113

Résumé

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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