Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
- 试验地点
- 33
- 主要终点
- worst-ever LV ejection fraction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <21 years.
- •Fever ≥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 tests. Organ 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
排除标准
- •No plausible alternative diagnosis, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes
结局指标
主要结局
worst-ever LV ejection fraction
时间窗: hospital admission through 5 years post-hospitalization
worst left ventricular (LV) ejection fraction from core lab echo read during MUSIC study
worst-ever maximum z score of the proximal LAD or RCA
时间窗: 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
次要结局
- valvar regurgitation(hospital admission through 5 years post-hospitalization)
- elevated extracellular volume fraction(hospital admission through 5 years post-hospitalization)
- LVSF(hospital admission through 5 years post-hospitalization)
- Individual z scores for LMCA, RCA and LAD(hospital admission through 5 years post-hospitalization)
- LVEDV z score(hospital admission through 5 years post-hospitalization)
- Qualitative assessment of RV systolic function(hospital admission through 5 years post-hospitalization)
- Qualitative assessment of RV global longitudinal strain(hospital admission through 5 years post-hospitalization)
- Presence and degree of mitral and aortic regurgitation(hospital admission through 5 years post-hospitalization)
- MRI RVEF(hospital admission through 5 years post-hospitalization)
- elevated T2(hospital admission through 5 years post-hospitalization)
- Occurrence of a proximal LAD or RCA z score of ≥2.5 on any echocardiogram(hospital admission through 5 years post-hospitalization)
- Occurrence of aneurysms by Japanese Ministry of Health criteria(hospital admission through 5 years post-hospitalization)
- LVEF(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(hospital admission through 5 years post-hospitalization)
- Presence and size of pericardial effusion(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(3 months post-discharge)
- MRI LVEF(hospital admission through 5 years post-hospitalization)
- elevated native T1(hospital admission through 5 years post-hospitalization)
- Maximal vasoactive inotrope score(from MIS-C hospital admission to MIS-C hospital discharge)
- LV strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view)(hospital admission through 5 years post-hospitalization)
- Other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic(hospital admission through 5 years post-hospitalization)
- Admission to ICU(hospital admission through 5 years post-hospitalization)
- Symptom duration(hospital admission through 5 years post-hospitalization)
- Global Health - FSS(hospital admission through 5 years post-hospitalization)
- LV diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow(hospital admission through 5 years post-hospitalization)
- myocardial late gadolinium enhancement (LGE)(hospital admission through 5 years post-hospitalization)
- abnormal T2-weighted imaging(hospital admission through 5 years post-hospitalization)
- coronary artery dilation(hospital admission through 5 years post-hospitalization)
- CRP(hospital admission through 5 years post-hospitalization)
- Hospital length of stay(from MIS-C hospital admission to MIS-C hospital discharge)
- Mortality(hospital admission through 5 years post-hospitalization)
- Global Health - PROMIS(hospital admission through 5 years post-hospitalization)
- CMR abnormal, equivocal, or negative(hospital admission through 5 years post-hospitalization)
- Major medical events(hospital admission through 5 years post-hospitalization)