Cardiovascular Assessment 5 Years After MIS-C
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Warsaw
About this trial
Multisystem inflammatory syndrome in children (MIS-C) is a severe complication associated with SARS-CoV-2 infection that frequently affects the cardiovascular system. Although acute cardiac abnormalities usually resolve, the long-term cardiovascular consequences of MIS-C remain uncertain. Previous follow-up of this cohort 2 years after MIS-C identified signs of subclinical cardiovascular abnormalities compared with healthy controls.
This cross-sectional study aims to evaluate cardiovascular health in individuals 5 years after MIS-C. Participants with a history of MIS-C will be compared with age- and sex-matched healthy controls using cardiovascular imaging, vascular assessments, cardiopulmonary exercise testing, and biomarkers of endothelial injury.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
For the MIS-C group: History of MIS-C diagnosed according to World Health Organization (WHO) criteria
For all participants: Written informed consent from a parent or legal guardian and, where applicable, assent/consent from participants aged 16 years or older /
Disqualifiers
Known heart disease, including congenital heart disease.
Significant chronic disease affecting growth, development, or daily functioning.
Elimination diet.
Competitive athletic training.
Trial population
Study Population MIS-C group: Individuals hospitalized at the Children's Clinical Hospital of the Medical University of Warsaw with a diagnosis of multisystem inflammatory syndrome in children (MIS-C) between October 2020 and February 2021. Control group: Healthy age- and sex-matched individuals recruited from primary care clinics in Warsaw.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: MIS-C group
Group B: Healthy controls
Trial outcomes
Primary outcomes
1
Aortic (central) systolic blood pressure
Central systolic blood pressure measured using pulse wave analysis.
Time frame
At the study visit, approximately 5 years after MIS-C diagnosisSecondary outcomes
1
Peripheral blood pressure
Peripheral systolic and diastolic blood pressure measurements
Time frame
At the study visit, approximately 5 years after MIS-C diagnosis2
Arterial stiffness
Vascular stiffness assessed by pulse wave velocity and pulse wave analysis-derived parameters
Time frame
At the study visit, approximately 5 years after MIS-C diagnosis3
Carotid intima-media thickness
Carotid intima-media thickness measured by ultrasound
Time frame
At the study visit, approximately 5 years after MIS-C diagnosis4
Endothelial injury biomarker concentrations
Serum concentrations of galectin-3, soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1)
Time frame
At the study visit, approximately 5 years after MIS-C diagnosisSponsors and contacts
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Source ClinicalTrials.gov