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Multisystem Inflammatory Syndrome in Children (MIS-C)NCT07659847

Cardiovascular Assessment 5 Years After MIS-C

An observational study of Multisystem Inflammatory Syndrome in Children (MIS-C) and SARS-CoV-2 Infection, run by Medical University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
90 participants
Where
1 sitePoland
Study dates
22 Nov 2025to 31 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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 /

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weronika Woźniak-Szewczyk, MD contact

+48 22 317 9231

wwozniakszewczyk@gmail.com

Magdalena Okarska-Napierała, MD PhD contact

+48 22 317 9231

magdalena.okarska-napierala@wum.edu.pl

Poland1 site, 1 recruiting
  • Medical University of Warsaw Children's Clinical Hospital

    Warsaw, Masovian Voivodeship

    Weronika Woźniak-Szewczyk, MD, +48 22 317 9231, wwozniakszewczyk@gmail.com

    Recruiting

Other trials in Poland

About this study

Official title: 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.

Read the 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.

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
Medical subject headings
pediatric multisystem inflammatory disease, COVID-19 related, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07659847
Study groupRoleWhat they receive
MIS-C groupChildren and young adults 5 years after MIS-C
Healthy controlsChildren and young adults without significant chronic disease, frequency-matched to the MIS-C group by age, sex, and BMI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aortic (central) systolic blood pressure

    Central systolic blood pressure measured using pulse wave analysis.

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

Secondary outcomes (7)
  1. Peripheral blood pressure

    Peripheral systolic and diastolic blood pressure measurements

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

  2. Arterial stiffness

    Vascular stiffness assessed by pulse wave velocity and pulse wave analysis-derived parameters

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

  3. Carotid intima-media thickness

    Carotid intima-media thickness measured by ultrasound

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

  4. 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)

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

  5. Echocardiographic parameters

    Cardiac structure and function assessed by transthoracic echocardiography

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

  6. Cardiopulmonary exercise capacity

    Exercise capacity and cardiopulmonary response assessed by cardiopulmonary exercise testing on a cycle ergometer.

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

  7. Comparison of cardiovascular outcomes between MIS-C participants and healthy controls

    Comparison of cardiovascular, vascular, and endothelial function parameters between participants with a history of MIS-C and healthy controls.

    Measured: At the study visit, approximately 5 years after MIS-C diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start22 Nov 2025
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07659847
Sponsor's protocol ID
KB/86/2025
Other IDs
2W9/1/M/MGN25
Status last verified
May 2026
First submitted
15 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Belhadjer Z, Meot M, Bajolle F, Khraiche D, Legendre A, Abakka S, Auriau J, Grimaud M, Oualha M, Beghetti M, Wacker J, Ovaert C, Hascoet S, Selegny M, Malekzadeh-Milani S, Maltret A, Bosser G, Giroux N, Bonnemains L, Bordet J, Di Filippo S, Mauran P, Falcon-Eicher S, Thambo JB, Lefort B, Moceri P, Houyel L, Renolleau S, Bonnet D. Acute Heart Failure in Multisystem Inflammatory Syndrome in Children in the Context of Global SARS-CoV-2 Pandemic. Circulation. 2020 Aug 4;142(5):429-436. doi: 10.1161/CIRCULATIONAHA.120.048360. Epub 2020 May 17.

    PubMed 32418446
  • Abrams JY, Oster ME, Godfred-Cato SE, Bryant B, Datta SD, Campbell AP, Leung JW, Tsang CA, Pierce TJ, Kennedy JL, Hammett TA, Belay ED. Factors linked to severe outcomes in multisystem inflammatory syndrome in children (MIS-C) in the USA: a retrospective surveillance study. Lancet Child Adolesc Health. 2021 May;5(5):323-331. doi: 10.1016/S2352-4642(21)00050-X. Epub 2021 Mar 10.

    PubMed 33711293
  • Clark BC, Sanchez-de-Toledo J, Bautista-Rodriguez C, Choueiter N, Lara D, Kang H, Mohsin S, Fraisse A, Cesar S, Sattar Shaikh A, Escobar-Diaz MC, Hsu DT, Randanne PC, Aslam N, Kleinmahon J, Lamour JM, Johnson JN, Sarquella-Brugada G, Chowdhury D. Cardiac Abnormalities Seen in Pediatric Patients During the SARS-CoV2 Pandemic: An International Experience. J Am Heart Assoc. 2020 Nov 3;9(21):e018007. doi: 10.1161/JAHA.120.018007. Epub 2020 Sep 22.

    PubMed 32957826
  • Krupickova S, Bautista-Rodriguez C, Hatipoglu S, Kang H, Fraisse A, Di Salvo G, Piccinelli E, Rowlinson G, Lane M, Altamar Bermejo I, Moscatelli S, Wage R, Mohiaddin R, Pennell DJ, Voges I. Myocardial deformation assessed by CMR in children after multisystem inflammatory syndrome (MIS-C). Int J Cardiol. 2022 Jan 1;346:105-106. doi: 10.1016/j.ijcard.2021.11.036. Epub 2021 Nov 16.

    PubMed 34798209
  • Feldstein LR, Tenforde MW, Friedman KG, Newhams M, Rose EB, Dapul H, Soma VL, Maddux AB, Mourani PM, Bowens C, Maamari M, Hall MW, Riggs BJ, Giuliano JS Jr, Singh AR, Li S, Kong M, Schuster JE, McLaughlin GE, Schwartz SP, Walker TC, Loftis LL, Hobbs CV, Halasa NB, Doymaz S, Babbitt CJ, Hume JR, Gertz SJ, Irby K, Clouser KN, Cvijanovich NZ, Bradford TT, Smith LS, Heidemann SM, Zackai SP, Wellnitz K, Nofziger RA, Horwitz SM, Carroll RW, Rowan CM, Tarquinio KM, Mack EH, Fitzgerald JC, Coates BM, Jackson AM, Young CC, Son MBF, Patel MM, Newburger JW, Randolph AG; Overcoming COVID-19 Investigators. Characteristics and Outcomes of US Children and Adolescents With Multisystem Inflammatory Syndrome in Children (MIS-C) Compared With Severe Acute COVID-19. JAMA. 2021 Mar 16;325(11):1074-1087. doi: 10.1001/jama.2021.2091.

    PubMed 33625505
  • Whittaker E, Bamford A, Kenny J, Kaforou M, Jones CE, Shah P, Ramnarayan P, Fraisse A, Miller O, Davies P, Kucera F, Brierley J, McDougall M, Carter M, Tremoulet A, Shimizu C, Herberg J, Burns JC, Lyall H, Levin M; PIMS-TS Study Group and EUCLIDS and PERFORM Consortia. Clinical Characteristics of 58 Children With a Pediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-CoV-2. JAMA. 2020 Jul 21;324(3):259-269. doi: 10.1001/jama.2020.10369.

    PubMed 32511692
  • Flood J, Shingleton J, Bennett E, Walker B, Amin-Chowdhury Z, Oligbu G, Avis J, Lynn RM, Davis P, Bharucha T, Pain CE, Jyothish D, Whittaker E, Dwarakanathan B, Wood R, Williams C, Swann O, Semple MG, Ramsay ME, Jones CE, Ramanan AV, Gent N, Ladhani SN. Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 (PIMS-TS): Prospective, national surveillance, United Kingdom and Ireland, 2020. Lancet Reg Health Eur. 2021 Apr;3:100075. doi: 10.1016/j.lanepe.2021.100075. Epub 2021 Mar 22.

    PubMed 34027512

Questions about this trial

What is this clinical trial studying?

An observational study of Multisystem Inflammatory Syndrome in Children (MIS-C) and SARS-CoV-2 Infection, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weronika Woźniak-Szewczyk, MD (+48 22 317 9231, wwozniakszewczyk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aortic (central) systolic blood pressure (time frame: At the study visit, approximately 5 years after MIS-C diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07659847, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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