Multisystem Inflammatory Syndrome in Children (MIS-C), SARS-CoV-2 Infection
Conditions
Keywords
Pediatric Inflammatory Multisystem Syndrome (PIMS), SARS-CoV-2, Endothelial Dysfunction, Cardiovascular Health, Long-Term Outcomes, Multisystem Inflammatory Syndrome in Children (MIS-C), Arterial Stiffness
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: * laboratory testing (complete blood count, fasting glucose, HbA1c, lipid profile); * assessment of endothelial injury biomarkers, including galectin-3, soluble vascular cell adhesion molecule-1 (sVCAM-1), and soluble intercellular adhesion molecule-1 (sICAM-1); * arterial stiffness assessment using pulse wave analysis and pulse wave velocity measurements; * carotid intima-media thickness (cIMT) ultrasound; * transthoracic echocardiography; * cardiopulmonary exercise testing on a cycle ergometer. The primary outcome is aortic (central) systolic blood pressure. Secondary outcomes include peripheral blood pressure, vascular stiffness parameters, carotid intima-media thickness, echocardiographic parameters, cardiopulmonary exercise test results, and concentrations of galectin-3, sICAM-1, and sVCAM-1. Outcomes will be compared between participants with a history of MIS-C and healthy controls to determine whether subclinical cardiovascular abnormalities persist 5 years after MIS-C. The study is expected to provide important information regarding the long-term cardiovascular health of post-MIS-C patients and may help identify individuals who could benefit from ongoing cardiovascular surveillance.
Interventions
None listed
Sponsors
Study design
Eligibility
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: 1. Known heart disease, including congenital heart disease. 2. Significant chronic disease affecting growth, development, or daily functioning. Control group: 1. Elimination diet. 2. Competitive athletic training. 3. Known heart disease, including congenital heart disease. 4. Significant chronic disease affecting growth, development, or daily functioning.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic (central) systolic blood pressure | At the study visit, approximately 5 years after MIS-C diagnosis | Central systolic blood pressure measured using pulse wave analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral blood pressure | At the study visit, approximately 5 years after MIS-C diagnosis | Peripheral systolic and diastolic blood pressure measurements |
| Arterial stiffness | At the study visit, approximately 5 years after MIS-C diagnosis | Vascular stiffness assessed by pulse wave velocity and pulse wave analysis-derived parameters |
| Carotid intima-media thickness | At the study visit, approximately 5 years after MIS-C diagnosis | Carotid intima-media thickness measured by ultrasound |
| Endothelial injury biomarker concentrations | At the study visit, approximately 5 years after MIS-C diagnosis | Serum concentrations of galectin-3, soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1) |
| Echocardiographic parameters | At the study visit, approximately 5 years after MIS-C diagnosis | Cardiac structure and function assessed by transthoracic echocardiography |
| Cardiopulmonary exercise capacity | At the study visit, approximately 5 years after MIS-C diagnosis | Exercise capacity and cardiopulmonary response assessed by cardiopulmonary exercise testing on a cycle ergometer. |
| Comparison of cardiovascular outcomes between MIS-C participants and healthy controls | At the study visit, approximately 5 years after MIS-C diagnosis | Comparison of cardiovascular, vascular, and endothelial function parameters between participants with a history of MIS-C and healthy controls. |
Countries
Poland