Long-TerM OUtcomes after the Multisystem Inflammatory Syndrome In Children:
R
R. Mark Payne, MD
Primary Investigator
Enrolling By Invitation
21 years and younger
All
Phase
N/A
600 participants needed
1 Location
Brief description of study
To determine the spectrum and time course of coronary artery involvement, left ventricular (LV) systolic function, and arrhythmias or conduction system disturbances within the first year from illness onset,
Detailed description of study
The proposed longitudinal follow-up study will be the first to define long-term cardiovascular health status following MIS-C. In addition, this study will contribute important new information on acute cardiac findings, including standardized measures of myocardial performance and coronary artery aneurysms. The study will include an Echocardiographic Core Lab to ensure the uniformity of cardiac phenotyping. We will also include a Core Lab for cardiac MRIs performed ~3 months after MIS-C onset for those children with a history of ≥moderate LV dysfunction to characterize myocardial abnormalities such as late gadolinium enhancement.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Multisystem Inflammatory Syndrome, Riley
-
Age: - 21 Years
-
Gender: All
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.
Updated on
13 Sep 2024.
Study ID: 2010277325; 2020-0702
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