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The NHLBI Study on Long-terM OUtcomes after the Multisystem Inflammatory Syndrome In Children (MUSIC): Design and
Dongngan T Truong1, Felicia L Trachtenberg2, Gail D Pearson3
1Department of Pediatrics, Dvision of Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA.
Insights
The Long-term Outcomes after Multisystem Inflammatory Syndrome in Children (MUSIC) study tracks cardiac and non-cardiac issues in children with MIS-C. This research provides crucial data on the long-term effects of this COVID-19-related condition.
Area of Science:
- Pediatric Infectious Diseases
- Cardiology
- Public Health
Background:
- Multisystem Inflammatory Syndrome in Children (MIS-C) is a serious condition linked to COVID-19.
- The long-term health consequences of MIS-C, particularly cardiac and non-cardiac sequelae, are not well understood.
- Characterizing these outcomes is critical for managing the public health impact of COVID-19 in children.
Purpose of the Study:
- To characterize the frequency and time course of acute and long-term cardiac and non-cardiac sequelae in children diagnosed with MIS-C.
- To establish a large, well-characterized cohort for studying MIS-C outcomes.
- To provide phenotypic data for future basic and translational research.
Main Methods:
- A multicenter observational cohort study enrolling at least 600 patients under 21 years old diagnosed with MIS-C.
- Collection of detailed hospital and up to 5-year follow-up data, including optional genetic testing.
- Standardized echocardiography for all participants and cardiac MRI for select patients with reduced ejection fraction; primary outcomes include worst LVEF and coronary artery z-scores.
Main Results:
- The study is ongoing, with data collection over 2 years and follow-up for up to 5 years.
- Primary outcomes focus on left ventricular ejection fraction (LVEF) and coronary artery abnormalities.
- Secondary outcomes assess non-cardiac organ dysfunction, inflammation, and major medical events.
Conclusions:
- The MUSIC study represents the largest cohort and longest follow-up for MIS-C patients to date.
- Findings will significantly advance the understanding of acute and long-term manifestations of MIS-C.
- This research is vital for addressing the long-term health effects of this public health emergency in children.
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.
