MUSIC: Long-TerM OUtcomes after the Multisystem Inflammatory Syndrome In Children

This study is an observational cohort study that will use routinely-collected clinical and cardiac (EKG, echocardiogram, CMR, exercise testing) data to assess the association between MIS-C (multisystem inflammatory syndrome in children) 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. Our 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. We will include all eligible patients, including retrospective cases beginning January 1, 2020, with follow-up (in-person or telehealth) up to 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, we 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. We will include a HIPAA-compliant cryptographic algorithm to create a sharable “hashed” identifier from patient information. If blood work for research purposes is added to usual clinically-indicated blood work during follow-up visits, this will be covered by other informed consent forms. Our primary outcomes are the largest proximal Left Anterior Descending Coronary Artery (LAD) or Right Coronary Artery (RCA) z score and lowest Left Ventricular Ejection Fraction (LVEF).]]>
Inclusion Criteria Age <21 yearsFever ≥38°C for ≥24 hours, or report of subjective fever lasting ≥24 hours 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. Evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement, based on clinical judgment from record review, discharge diagnosis, laboratory or diagnostic testsOrgan system involvement includes, but is not limited to cardiac, renal, respiratory, hematologic including coagulopathy, gastrointestinal including liver, dermatologic or neurological 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: Plausible alternative diagnosis, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes ]]>