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Cardiovascular Assessment 5 Years After MIS-C

Cardiovascular Evaluation 5 Years After Multisystem Inflammatory Syndrome in Children (MIS-C)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07659847
Enrollment
90
Registered
2026-06-22
Start date
2025-11-22
Completion date
2027-03-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multisystem Inflammatory Syndrome in Children (MIS-C), SARS-CoV-2 Infection

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

Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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: 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

MeasureTime frameDescription
Aortic (central) systolic blood pressureAt the study visit, approximately 5 years after MIS-C diagnosisCentral systolic blood pressure measured using pulse wave analysis.

Secondary

MeasureTime frameDescription
Peripheral blood pressureAt the study visit, approximately 5 years after MIS-C diagnosisPeripheral systolic and diastolic blood pressure measurements
Arterial stiffnessAt the study visit, approximately 5 years after MIS-C diagnosisVascular stiffness assessed by pulse wave velocity and pulse wave analysis-derived parameters
Carotid intima-media thicknessAt the study visit, approximately 5 years after MIS-C diagnosisCarotid intima-media thickness measured by ultrasound
Endothelial injury biomarker concentrationsAt the study visit, approximately 5 years after MIS-C diagnosisSerum concentrations of galectin-3, soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1)
Echocardiographic parametersAt the study visit, approximately 5 years after MIS-C diagnosisCardiac structure and function assessed by transthoracic echocardiography
Cardiopulmonary exercise capacityAt the study visit, approximately 5 years after MIS-C diagnosisExercise capacity and cardiopulmonary response assessed by cardiopulmonary exercise testing on a cycle ergometer.
Comparison of cardiovascular outcomes between MIS-C participants and healthy controlsAt the study visit, approximately 5 years after MIS-C diagnosisComparison of cardiovascular, vascular, and endothelial function parameters between participants with a history of MIS-C and healthy controls.

Countries

Poland

Contacts

CONTACTWeronika Woźniak-Szewczyk, MD
wwozniakszewczyk@gmail.com+48 22 317 9231
CONTACTMagdalena Okarska-Napierała, MD PhD
magdalena.okarska-napierala@wum.edu.pl+48 22 317 9231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026