Cardiovascular Evaluation 5 Years After Multisystem Inflammatory Syndrome in Children (MIS-C)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Aortic (central) systolic blood pressure
Study Overview
Brief Summary
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.
Detailed Description
Multisystem inflammatory syndrome in children (MIS-C) is a rare but severe hyperinflammatory condition associated with SARS-CoV-2 infection. Cardiovascular involvement is common during the acute phase of the disease and may include myocardial dysfunction, arrhythmias, hypotension, and coronary artery abnormalities. Although most patients experience rapid clinical recovery following immunomodulatory treatment, the long-term cardiovascular consequences of MIS-C remain incompletely understood.
The investigators previously evaluated cardiovascular health approximately 2 years after MIS-C and found evidence of subclinical cardiovascular abnormalities, including higher blood pressure values, increased concentrations of biomarkers associated with endothelial injury, and increased carotid intima-media thickness compared with healthy controls. These findings suggested that vascular changes may persist beyond the acute phase of the disease.
The aim of the present study is to assess cardiovascular health 5 years after MIS-C and to determine whether cardiovascular abnormalities remain detectable in long-term follow-up.
This is a cross-sectional study with a healthy control group. The MIS-C group will consist of individuals who were hospitalized with MIS-C at the Department of Pediatrics of the Medical University of Warsaw Children's Clinical Hospital between October 2020 and February 2021. Healthy controls will be recruited from primary care clinics and matched to the MIS-C group by age and sex.
All participants will undergo a comprehensive cardiovascular evaluation including:
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 /
Exclusion Criteria
- •MIS-C group:
- •Known heart disease, including congenital heart disease.
- •Significant chronic disease affecting growth, development, or daily functioning.
- •Control group:
- •Elimination diet.
- •Competitive athletic training.
- •Known heart disease, including congenital heart disease.
- •Significant chronic disease affecting growth, development, or daily functioning.
Arms & Interventions
MIS-C group
Children and young adults 5 years after MIS-C
Healthy controls
Children and young adults without significant chronic disease, frequency-matched to the MIS-C group by age, sex, and BMI.
Outcomes
Primary Outcomes
Aortic (central) systolic blood pressure
Time Frame: At the study visit, approximately 5 years after MIS-C diagnosis
Central systolic blood pressure measured using pulse wave analysis.
Secondary Outcomes
- Peripheral blood pressure(At the study visit, approximately 5 years after MIS-C diagnosis)
- Arterial stiffness(At the study visit, approximately 5 years after MIS-C diagnosis)
- Carotid intima-media thickness(At the study visit, approximately 5 years after MIS-C diagnosis)
- Endothelial injury biomarker concentrations(At the study visit, approximately 5 years after MIS-C diagnosis)
- Echocardiographic parameters(At the study visit, approximately 5 years after MIS-C diagnosis)
- Cardiopulmonary exercise capacity(At the study visit, approximately 5 years after MIS-C diagnosis)
- Comparison of cardiovascular outcomes between MIS-C participants and healthy controls(At the study visit, approximately 5 years after MIS-C diagnosis)