Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children (MUSIC)

March 26, 2026 updated by: Carelon Research
Multi-system Inflammatory Syndrome in Children (MIS-C) is a new condition related to COVID-19, the study investigators are still learning about its causes, effects, and long-term impact. "Long-Term Outcomes after the Multisystem Inflammatory Syndrome In Children", the Coronavirus MUSIC Study, is a research study funded by NIH and the National Heart, Lung, and Blood Institute. The study investigators hope to enroll at least 900 young people with MIS-C at children's medical centers in the U.S. and Canada. This research study will help us learn more about MIS-C and its effects on the long-term health of children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is an observational cohort study that will use routinely collected clinical and cardiac (EKG, echocardiogram, Cardiac MRI, exercise testing) data to assess the association between MIS-C and cardiac outcomes within the first year after hospital discharge. Research funding will be available for EKGs, echocardiograms and MRIs in protocol windows that are not ordered by primary caregivers. The principal goal is to determine the spectrum and early time course of coronary artery involvement, LV systolic function, and arrhythmias or conduction system abnormalities, and, using these data, to define associated clinical and laboratory factors. The study investigators planned to include all eligible patients, including retrospective cases beginning January 1, 2020, with follow-up (in-person or telehealth) to up within one year and annual medical history forms until up to 5 years have elapsed since illness onset. Because many patients will have been identified by retrospective review, the study team will obtain consent at different times in their illness course. For this reason, it may be hard to reach some patients and their families. Waiver of consent will be obtained after three attempts have been made to locate the patient and family without success, as well as for the rare child who dies before informed consent can be obtained. The study investigators will include a HIPAA-compliant cryptographic algorithm to create a sharable "hashed" identifier from patient information. If blood work for research purposes is added on to usual clinically indicated blood work during follow-up visits, this will be covered by other informed consent forms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35401
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Madera, California, United States, 93636
        • Valley Children's Healthcare and Hospital
      • San Diego, California, United States, 92131
        • UC San Diego, Rady Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital of Colorado
    • Delaware
      • Wilmington, Delaware, United States, 19808
        • The Nemours Foundation
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Children's National Hospital
    • Florida
      • Hollywood, Florida, United States, 33021
        • Joe DiMaggio Children's Hospital
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Chldren's Healthcare of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert Lurid Children's Hospital of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital of New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • CS Mott Children's Hospital/University of Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • New York
      • New York, New York, United States, 10032
        • Morgan Stanley Children's Hospital of New York
      • Queens, New York, United States, 11040
        • Cohen Children's Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Children's Hospital and Health Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Austin, Texas, United States, 78707
        • Dell Medical Center
      • Dallas, Texas, United States, 75235
        • Children's Medical Center of Dallas - UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor /Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin/Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children and young adults <21 years with Multisystem Inflammatory Syndrome in Children associated with COVID-19 (MIS-C) at a participating hospital

Description

Inclusion Criteria:

  1. Age <21 years.
  2. Fever ≥38°C for ≥24 hours, or report of subjective fever lasting ≥24 hours.
  3. Laboratory evidence of inflammation, including, but not limited to, one or more of the following: an elevated CRP, ESR, fibrinogen, procalcitonin, d-dimer, ferritin, LDH, or IL-6, elevated neutrophils, reduced lymphocytes and low albumin.
  4. Evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement, based on clinical judgment from record review, discharge diagnosis, laboratory or diagnostic tests. Organ system involvement includes but is not limited to cardiac, renal, respiratory, hematologic including coagulopathy, gastrointestinal including liver, dermatologic or neurological.
  5. Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms

Exclusion Criteria:

  • No plausible alternative diagnosis, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
worst-ever LV ejection fraction
Time Frame: hospital admission through 5 years post-hospitalization
worst left ventricular (LV) ejection fraction from core lab echo read during MUSIC study
hospital admission through 5 years post-hospitalization
worst-ever maximum z score of the proximal LAD or RCA
Time Frame: hospital admission through 5 years post-hospitalization
worst maximum z-score of the proximal left anterior descending coronary artery (LAD) or right coronary artery (RCA) from core lab echo read; z-scores to be calculated via Boston z-score calculator (primary) and Pediatric Heart Network z-score calculator (secondary); higher z-scores are worse
hospital admission through 5 years post-hospitalization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of a proximal LAD or RCA z score of ≥2.5 on any echocardiogram
Time Frame: hospital admission through 5 years post-hospitalization
proximal left anterior descending coronary artery (LAD) or right coronary artery (RCA) ≥2.5 from any core lab echo read
hospital admission through 5 years post-hospitalization
Occurrence of aneurysms by Japanese Ministry of Health criteria
Time Frame: hospital admission through 5 years post-hospitalization
Occurrence of aneurysms by Japanese Ministry of Health criteria applied to core lab echo reads
hospital admission through 5 years post-hospitalization
Individual z scores for LMCA, RCA and LAD
Time Frame: hospital admission through 5 years post-hospitalization
Individual z scores for left main coronary artery (LMCA), right coronary artery (RCA) and proximal left anterior descending coronary artery (LAD) as per core lab echo reads; higher z-scores are worse
hospital admission through 5 years post-hospitalization
LVEDV z score
Time Frame: hospital admission through 5 years post-hospitalization
left ventricular (LV) size as measured by left ventricular end-diastolic volume (LVEDV) z score
hospital admission through 5 years post-hospitalization
LVEF
Time Frame: hospital admission through 5 years post-hospitalization
left ventricular (LV) function as measured by left ventricular ejection fraction (LVEF)
hospital admission through 5 years post-hospitalization
LVSF
Time Frame: hospital admission through 5 years post-hospitalization
left ventricular (LV) function as measured by left ventricular shortening fraction (LVSF)
hospital admission through 5 years post-hospitalization
The percentage of patients who had LV ejection of <55%, and further categorization of 45-54% (i.e., mildly depressed systolic function), 35-44% (moderately depressed systolic function) and <35% (severely depressed systolic function) on any echocardiogram
Time Frame: hospital admission through 5 years post-hospitalization
The percentage of patients who had left ventricular (LV) ejection of <55%, and further categorization of 45-54% (i.e., mildly depressed systolic function), 35-44% (moderately depressed systolic function) and <35% (severely depressed systolic function) on any echocardiogram read by the core lab
hospital admission through 5 years post-hospitalization
LV strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view)
Time Frame: hospital admission through 5 years post-hospitalization
left ventricular (LV) strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view) on core lab echo read
hospital admission through 5 years post-hospitalization
Qualitative assessment of RV systolic function
Time Frame: hospital admission through 5 years post-hospitalization
Qualitative assessment of right ventricular (RV) systolic function on core lab echo read
hospital admission through 5 years post-hospitalization
Qualitative assessment of RV global longitudinal strain
Time Frame: hospital admission through 5 years post-hospitalization
Qualitative assessment, if possible, of right ventricular (RV) global longitudinal strain on core lab echo read
hospital admission through 5 years post-hospitalization
Presence and degree of mitral and aortic regurgitation
Time Frame: hospital admission through 5 years post-hospitalization
Presence and degree of mitral and aortic regurgitation on echo core lab read
hospital admission through 5 years post-hospitalization
LV diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow
Time Frame: hospital admission through 5 years post-hospitalization
left ventricular (LV) diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow on echo core lab read
hospital admission through 5 years post-hospitalization
Presence and size of pericardial effusion
Time Frame: hospital admission through 5 years post-hospitalization
Presence and size of pericardial effusion on echo core lab read
hospital admission through 5 years post-hospitalization
The occurrence of arrhythmias and conduction system disturbances by in-hospital monitoring, electrocardiograms, and exercise testing at 3 months in those with a history of ≥moderate systolic dysfunction when age and maturity permit
Time Frame: 3 months post-discharge
The occurrence of arrhythmias and conduction system disturbances by in-hospital monitoring, electrocardiograms, and exercise testing at 3 months in those with a history of ≥moderate systolic dysfunction when age and maturity permit
3 months post-discharge
MRI LVEF
Time Frame: hospital admission through 5 years post-hospitalization
LVEF on MRI core lab read
hospital admission through 5 years post-hospitalization
MRI RVEF
Time Frame: hospital admission through 5 years post-hospitalization
RVEF on MRI core lab read
hospital admission through 5 years post-hospitalization
valvar regurgitation
Time Frame: hospital admission through 5 years post-hospitalization
valvar regurgitation on MRI core lab read
hospital admission through 5 years post-hospitalization
myocardial late gadolinium enhancement (LGE)
Time Frame: hospital admission through 5 years post-hospitalization
percent with and distribution of myocardial late gadolinium enhancement (LGE) on MRI core lab read
hospital admission through 5 years post-hospitalization
abnormal T2-weighted imaging
Time Frame: hospital admission through 5 years post-hospitalization
percent abnormal T2-weighted imaging on MRI core lab read
hospital admission through 5 years post-hospitalization
elevated T2
Time Frame: hospital admission through 5 years post-hospitalization
percent with elevated T2 on MRI core lab read
hospital admission through 5 years post-hospitalization
elevated native T1
Time Frame: hospital admission through 5 years post-hospitalization
percent with elevated native T1 on MRI core lab read
hospital admission through 5 years post-hospitalization
elevated extracellular volume fraction
Time Frame: hospital admission through 5 years post-hospitalization
percent with elevated extracellular volume fraction on MRI core lab read
hospital admission through 5 years post-hospitalization
coronary artery dilation
Time Frame: hospital admission through 5 years post-hospitalization
percent with coronary artery dilation on MRI core lab read
hospital admission through 5 years post-hospitalization
CMR abnormal, equivocal, or negative
Time Frame: hospital admission through 5 years post-hospitalization
final interpretation of CMR as abnormal, equivocal, or negative (i.e., no abnormal or equivocal findings) on MRI core lab read
hospital admission through 5 years post-hospitalization
Other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic
Time Frame: hospital admission through 5 years post-hospitalization
percent with other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic
hospital admission through 5 years post-hospitalization
CRP
Time Frame: hospital admission through 5 years post-hospitalization
C-Reactive Protein (CRP) as a laboratory marker of inflammation
hospital admission through 5 years post-hospitalization
Admission to ICU
Time Frame: hospital admission through 5 years post-hospitalization
percent with admission to ICU
hospital admission through 5 years post-hospitalization
Maximal vasoactive inotrope score
Time Frame: from MIS-C hospital admission to MIS-C hospital discharge
Maximal vasoactive inotrope score
from MIS-C hospital admission to MIS-C hospital discharge
Hospital length of stay
Time Frame: from MIS-C hospital admission to MIS-C hospital discharge
Hospital length of stay
from MIS-C hospital admission to MIS-C hospital discharge
Symptom duration
Time Frame: hospital admission through 5 years post-hospitalization
Symptom duration
hospital admission through 5 years post-hospitalization
Major medical events
Time Frame: hospital admission through 5 years post-hospitalization
percent with major medical events (e.g., stroke, need for extracorporeal therapies such as renal replacement therapy, plasma exchange, ECMO, VAD)
hospital admission through 5 years post-hospitalization
Mortality
Time Frame: hospital admission through 5 years post-hospitalization
Percent mortality
hospital admission through 5 years post-hospitalization
Global Health - FSS
Time Frame: hospital admission through 5 years post-hospitalization
Global Health as measured by Functional Status Score [FSS]: range 6-30, lower is better
hospital admission through 5 years post-hospitalization
Global Health - PROMIS
Time Frame: hospital admission through 5 years post-hospitalization
Global Health as measured by Parent-Reported Outcomes Measurement Information Systems [PROMIS] Instrument: range 7-35, higher is better
hospital admission through 5 years post-hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carelon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G20479

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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