Cardiovascular Assessment 5 Years After MIS-C

NCT07659847 | Recruiting

• 2 other identifiers: KB/86/20252W9/1/M/MGN25
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Aortic (central) systolic blood pressure

  Central systolic blood pressure measured using pulse wave analysis.

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

Secondary Outcomes (7)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 /

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw Children's Clinical Hospital

Warsaw, Masovian Voivodeship, Poland

RECRUITING

Related Publications (7)

• 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.

  PMID: 32418446 BACKGROUND

• 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.

  PMID: 33711293 BACKGROUND

• 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.

  PMID: 32957826 BACKGROUND

• 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.

  PMID: 34798209 BACKGROUND

• 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.

  PMID: 33625505 BACKGROUND

• 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.

  PMID: 32511692 BACKGROUND

• 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.

  PMID: 34027512 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples will be stored at -70°C until analysis of endothelial injury biomarkers (galectin-3, sICAM-1, and sVCAM-1). Any remaining biological material will be destroyed after completion of the planned laboratory analyses and will not be used for future research.

MeSH Terms

Conditions

pediatric multisystem inflammatory disease, COVID-19 related; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: November 22, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-05

Locations

PL (1)