Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children

N/AActive Not RecruitingNCT05287412

Carelon Research1,200 enrolled

Overview

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.

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

OBSERVATIONAL

Enrollment

1,200

Outcomes

Primary Outcomes

worst-ever LV ejection fraction

worst left ventricular (LV) ejection fraction from core lab echo read during MUSIC study

Time frame: hospital admission through 5 years post-hospitalization

worst-ever maximum z score of the proximal LAD or RCA

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

Time frame: hospital admission through 5 years post-hospitalization

Secondary Outcomes

Occurrence of a proximal LAD or RCA z score of ≥2.5 on any echocardiogram

proximal left anterior descending coronary artery (LAD) or right coronary artery (RCA) ≥2.5 from any core lab echo read

Time frame: hospital admission through 5 years post-hospitalization

Occurrence of aneurysms by Japanese Ministry of Health criteria

Occurrence of aneurysms by Japanese Ministry of Health criteria applied to core lab echo reads

Time frame: hospital admission through 5 years post-hospitalization

Individual z scores for LMCA, RCA and LAD

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

Time frame: hospital admission through 5 years post-hospitalization

LVEDV z score

left ventricular (LV) size as measured by left ventricular end-diastolic volume (LVEDV) z score

Time frame: hospital admission through 5 years post-hospitalization

LVEF

left ventricular (LV) function as measured by left ventricular ejection fraction (LVEF)

Time frame: hospital admission through 5 years post-hospitalization

LVSF

left ventricular (LV) function as measured by left ventricular shortening fraction (LVSF)

Time frame: 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

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

Time frame: hospital admission through 5 years post-hospitalization

LV strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view)

left ventricular (LV) strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view) on core lab echo read

Time frame: hospital admission through 5 years post-hospitalization

Qualitative assessment of RV systolic function

Qualitative assessment of right ventricular (RV) systolic function on core lab echo read

Time frame: hospital admission through 5 years post-hospitalization

Qualitative assessment of RV global longitudinal strain

Qualitative assessment, if possible, of right ventricular (RV) global longitudinal strain on core lab echo read

Time frame: hospital admission through 5 years post-hospitalization

Presence and degree of mitral and aortic regurgitation

Presence and degree of mitral and aortic regurgitation on echo core lab read

Time frame: hospital admission through 5 years post-hospitalization

LV diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow

left ventricular (LV) diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow on echo core lab read

Time frame: hospital admission through 5 years post-hospitalization

Presence and size of pericardial effusion

Presence and size of pericardial effusion on echo core lab read

Time frame: 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

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

MRI LVEF

LVEF on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

MRI RVEF

RVEF on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

valvar regurgitation

valvar regurgitation on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

myocardial late gadolinium enhancement (LGE)

percent with and distribution of myocardial late gadolinium enhancement (LGE) on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

abnormal T2-weighted imaging

percent abnormal T2-weighted imaging on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

elevated T2

percent with elevated T2 on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

elevated native T1

percent with elevated native T1 on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

elevated extracellular volume fraction

percent with elevated extracellular volume fraction on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

coronary artery dilation

percent with coronary artery dilation on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

CMR abnormal, equivocal, or negative

final interpretation of CMR as abnormal, equivocal, or negative (i.e., no abnormal or equivocal findings) on MRI core lab read

Time frame: hospital admission through 5 years post-hospitalization

Other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic

percent with other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic

Time frame: hospital admission through 5 years post-hospitalization

CRP

C-Reactive Protein (CRP) as a laboratory marker of inflammation

Time frame: hospital admission through 5 years post-hospitalization

Admission to ICU

percent with admission to ICU

Time frame: hospital admission through 5 years post-hospitalization

Maximal vasoactive inotrope score

Maximal vasoactive inotrope score

Time frame: from MIS-C hospital admission to MIS-C hospital discharge

Hospital length of stay

Hospital length of stay

Time frame: from MIS-C hospital admission to MIS-C hospital discharge

Symptom duration

Symptom duration

Time frame: hospital admission through 5 years post-hospitalization

Major medical events

percent with major medical events (e.g., stroke, need for extracorporeal therapies such as renal replacement therapy, plasma exchange, ECMO, VAD)

Time frame: hospital admission through 5 years post-hospitalization

Mortality

Percent mortality

Time frame: hospital admission through 5 years post-hospitalization

Global Health - FSS

Global Health as measured by Functional Status Score \[FSS\]: range 6-30, lower is better

Time frame: hospital admission through 5 years post-hospitalization

Global Health - PROMIS

Global Health as measured by Parent-Reported Outcomes Measurement Information Systems \[PROMIS\] Instrument: range 7-35, higher is better

Time frame: hospital admission through 5 years post-hospitalization

NCT05287412 - Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children | Crick | Crick