Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05287412
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000705967', 'term': 'pediatric multisystem inflammatory disease, COVID-19 related'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood or saliva that is collected for future whole genome sequencing will be requested as optional at any time that the patient is undergoing a clinical laboratory draw in participants who provide consent for this testing. To better understand the genetic variation within the heterogenous MIS-C population, blood or saliva samples from the biological parents of MIS-C patients will also be requested as optional. Samples from parents will also be stored at the similar venue for future whole genome sequencing. In addition, the study investigators expect to collaborate with centers or networks that are collecting research samples on these patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'worst-ever LV ejection fraction', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'worst left ventricular (LV) ejection fraction from core lab echo read during MUSIC study'}, {'measure': 'worst-ever maximum z score of the proximal LAD or RCA', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Occurrence of a proximal LAD or RCA z score of ≥2.5 on any echocardiogram', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'proximal left anterior descending coronary artery (LAD) or right coronary artery (RCA) ≥2.5 from any core lab echo read'}, {'measure': 'Occurrence of aneurysms by Japanese Ministry of Health criteria', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Occurrence of aneurysms by Japanese Ministry of Health criteria applied to core lab echo reads'}, {'measure': 'Individual z scores for LMCA, RCA and LAD', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': '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'}, {'measure': 'LVEDV z score', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'left ventricular (LV) size as measured by left ventricular end-diastolic volume (LVEDV) z score'}, {'measure': 'LVEF', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'left ventricular (LV) function as measured by left ventricular ejection fraction (LVEF)'}, {'measure': 'LVSF', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'left ventricular (LV) function as measured by left ventricular shortening fraction (LVSF)'}, {'measure': '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', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': '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'}, {'measure': 'LV strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view)', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'left ventricular (LV) strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view) on core lab echo read'}, {'measure': 'Qualitative assessment of RV systolic function', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Qualitative assessment of right ventricular (RV) systolic function on core lab echo read'}, {'measure': 'Qualitative assessment of RV global longitudinal strain', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Qualitative assessment, if possible, of right ventricular (RV) global longitudinal strain on core lab echo read'}, {'measure': 'Presence and degree of mitral and aortic regurgitation', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Presence and degree of mitral and aortic regurgitation on echo core lab read'}, {'measure': 'LV diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'left ventricular (LV) diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow on echo core lab read'}, {'measure': 'Presence and size of pericardial effusion', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Presence and size of pericardial effusion on echo core lab read'}, {'measure': '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', 'timeFrame': '3 months post-discharge', 'description': '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'}, {'measure': 'MRI LVEF', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'LVEF on MRI core lab read'}, {'measure': 'MRI RVEF', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'RVEF on MRI core lab read'}, {'measure': 'valvar regurgitation', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'valvar regurgitation on MRI core lab read'}, {'measure': 'myocardial late gadolinium enhancement (LGE)', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with and distribution of myocardial late gadolinium enhancement (LGE) on MRI core lab read'}, {'measure': 'abnormal T2-weighted imaging', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent abnormal T2-weighted imaging on MRI core lab read'}, {'measure': 'elevated T2', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with elevated T2 on MRI core lab read'}, {'measure': 'elevated native T1', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with elevated native T1 on MRI core lab read'}, {'measure': 'elevated extracellular volume fraction', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with elevated extracellular volume fraction on MRI core lab read'}, {'measure': 'coronary artery dilation', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with coronary artery dilation on MRI core lab read'}, {'measure': 'CMR abnormal, equivocal, or negative', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'final interpretation of CMR as abnormal, equivocal, or negative (i.e., no abnormal or equivocal findings) on MRI core lab read'}, {'measure': 'Other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic'}, {'measure': 'CRP', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'C-Reactive Protein (CRP) as a laboratory marker of inflammation'}, {'measure': 'Admission to ICU', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with admission to ICU'}, {'measure': 'Maximal vasoactive inotrope score', 'timeFrame': 'from MIS-C hospital admission to MIS-C hospital discharge', 'description': 'Maximal vasoactive inotrope score'}, {'measure': 'Hospital length of stay', 'timeFrame': 'from MIS-C hospital admission to MIS-C hospital discharge', 'description': 'Hospital length of stay'}, {'measure': 'Symptom duration', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Symptom duration'}, {'measure': 'Major medical events', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'percent with major medical events (e.g., stroke, need for extracorporeal therapies such as renal replacement therapy, plasma exchange, ECMO, VAD)'}, {'measure': 'Mortality', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Percent mortality'}, {'measure': 'Global Health - FSS', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Global Health as measured by Functional Status Score \\[FSS\\]: range 6-30, lower is better'}, {'measure': 'Global Health - PROMIS', 'timeFrame': 'hospital admission through 5 years post-hospitalization', 'description': 'Global Health as measured by Parent-Reported Outcomes Measurement Information Systems \\[PROMIS\\] Instrument: range 7-35, higher is better'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID'], 'conditions': ['Multisystem Inflammatory Syndrome in Children (MIS-C)']}, 'referencesModule': {'references': [{'pmid': '40181776', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children and young adults \\<21 years with Multisystem Inflammatory Syndrome in Children associated with COVID-19 (MIS-C) at a participating hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\<21 years.\n2. Fever ≥38°C for ≥24 hours, or report of subjective fever lasting ≥24 hours.\n3. 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.\n4. 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.\n5. 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\n\nExclusion Criteria:\n\n* No plausible alternative diagnosis, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes'}, 'identificationModule': {'nctId': 'NCT05287412', 'acronym': 'MUSIC', 'briefTitle': 'Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': 'Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children', 'orgStudyIdInfo': {'id': 'G20479'}}, 'contactsLocationsModule': {'locations': [{'zip': '35401', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93636', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Valley Children's Healthcare and Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '92131', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "UC San Diego, Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital of Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19808', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'The Nemours Foundation', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': "Joe DiMaggio Children's Hospital", 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Chldren's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert Lurid Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Hospital", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's Hospital of New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "CS Mott Children's Hospital/University of Michigan", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Morgan Stanley Children's Hospital of New York", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11040', 'city': 'Queens', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center", 'geoPoint': {'lat': 40.68149, 'lon': -73.83652}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': "Duke Children's Hospital and Health Center", 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78707', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Dell Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center of Dallas - UT Southwestern Medical Center", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor /Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Medical College of Wisconsin/Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carelon Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}