Cardiovascular Assessment 5 Years After MIS-C

June 15, 2026 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland
        • Recruiting
        • Medical University of Warsaw Children's Clinical Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the study visit, approximately 5 years after MIS-C diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral blood pressure
Time Frame: At the study visit, approximately 5 years after MIS-C diagnosis
Peripheral systolic and diastolic blood pressure measurements
At the study visit, approximately 5 years after MIS-C diagnosis
Arterial stiffness
Time Frame: At the study visit, approximately 5 years after MIS-C diagnosis
Vascular stiffness assessed by pulse wave velocity and pulse wave analysis-derived parameters
At the study visit, approximately 5 years after MIS-C diagnosis
Carotid intima-media thickness
Time Frame: At the study visit, approximately 5 years after MIS-C diagnosis
Carotid intima-media thickness measured by ultrasound
At the study visit, approximately 5 years after MIS-C diagnosis
Endothelial injury biomarker concentrations
Time Frame: 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)
At the study visit, approximately 5 years after MIS-C diagnosis
Echocardiographic parameters
Time Frame: At the study visit, approximately 5 years after MIS-C diagnosis
Cardiac structure and function assessed by transthoracic echocardiography
At the study visit, approximately 5 years after MIS-C diagnosis
Cardiopulmonary exercise capacity
Time Frame: 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.
At the study visit, approximately 5 years after MIS-C diagnosis
Comparison of cardiovascular outcomes between MIS-C participants and healthy controls
Time Frame: 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.
At the study visit, approximately 5 years after MIS-C diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/86/2025
  • 2W9/1/M/MGN25 (Other Grant/Funding Number: Medical University of Warsaw)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SARS-CoV-2 Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe