Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children

NCT ID: NCT05287412

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2025-12-31

Brief Summary

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.

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.

Conditions

Multisystem Inflammatory Syndrome in Children (MIS-C)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carelon Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama

Tuscaloosa, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Valley Children's Healthcare and Hospital

Madera, California, United States

UC San Diego, Rady Children's Hospital

San Diego, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

The Nemours Foundation

Wilmington, Delaware, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Chldren's Healthcare of Atlanta

Atlanta, Georgia, United States

Ann & Robert Lurid Children's Hospital of Chicago

Chicago, Illinois, United States

Riley Children's Hospital

Indianapolis, Indiana, United States

Children's Hospital of New Orleans

New Orleans, Louisiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

CS Mott Children's Hospital/University of Michigan

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

University of Mississippi

Jackson, Mississippi, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Morgan Stanley Children's Hospital of New York

New York, New York, United States

Cohen Children's Medical Center

Queens, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke Children's Hospital and Health Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Dell Medical Center

Austin, Texas, United States

Children's Medical Center of Dallas - UT Southwestern Medical Center

Dallas, Texas, United States

Baylor /Texas Children's Hospital

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Medical College of Wisconsin/Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

United States; Canada

References

Lang SM, Truong DT, Powell AJ, Kazlova V, Newburger JW, Awerbach JD, Binka E, Bradford TT, Cartoski M, Cheng A, DiLorenzo MP, Dionne A, Dorfman AL, Elias MD, Garuba O, Gerardin JF, Hasbani K, Jone PN, Lam CZ, Misra N, Morgan LM, Nutting A, Patel JK, Robinson JD, Schuchardt EL, Sexson Tejtel K, Singh GK, Slesnick TC, Trachtenberg F, Taylor MD; MUSIC Study Investigators. CMR Findings in the Long-Term Outcomes After Multisystem Inflammatory Syndrome in Children (MUSIC) Study. Circ Cardiovasc Imaging. 2025 Sep;18(9):e017420. doi: 10.1161/CIRCIMAGING.124.017420. Epub 2025 Apr 4.

Reference Type: DERIVED

PMID: 40181776 (View on PubMed)

Other Identifiers

G20479

Identifier Type: -

Identifier Source: org_study_id