- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07659847
Cardiovascular Assessment 5 Years After MIS-C
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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Weronika Woźniak-Szewczyk, MD
- Telefonnummer: +48 22 317 9231
- E-Mail: wwozniakszewczyk@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Magdalena Okarska-Napierała, MD PhD
- Telefonnummer: +48 22 317 9231
- E-Mail: magdalena.okarska-napierala@wum.edu.pl
Studienorte
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen
- Rekrutierung
- Medical University of Warsaw Children's Clinical Hospital
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Kontakt:
- Weronika Woźniak-Szewczyk, MD
- Telefonnummer: +48 22 317 9231
- E-Mail: wwozniakszewczyk@gmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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MIS-C group
Children and young adults 5 years after MIS-C
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Healthy controls
Children and young adults without significant chronic disease, frequency-matched to the MIS-C group by age, sex, and BMI.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Aortic (central) systolic blood pressure
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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Central systolic blood pressure measured using pulse wave analysis.
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At the study visit, approximately 5 years after MIS-C diagnosis
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Peripheral blood pressure
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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Peripheral systolic and diastolic blood pressure measurements
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At the study visit, approximately 5 years after MIS-C diagnosis
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Arterial stiffness
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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Vascular stiffness assessed by pulse wave velocity and pulse wave analysis-derived parameters
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At the study visit, approximately 5 years after MIS-C diagnosis
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Carotid intima-media thickness
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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Carotid intima-media thickness measured by ultrasound
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At the study visit, approximately 5 years after MIS-C diagnosis
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Endothelial injury biomarker concentrations
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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Serum concentrations of galectin-3, soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1)
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At the study visit, approximately 5 years after MIS-C diagnosis
|
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Echocardiographic parameters
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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Cardiac structure and function assessed by transthoracic echocardiography
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At the study visit, approximately 5 years after MIS-C diagnosis
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Cardiopulmonary exercise capacity
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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Exercise capacity and cardiopulmonary response assessed by cardiopulmonary exercise testing on a cycle ergometer.
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At the study visit, approximately 5 years after MIS-C diagnosis
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Comparison of cardiovascular outcomes between MIS-C participants and healthy controls
Zeitfenster: At the study visit, approximately 5 years after MIS-C diagnosis
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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
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Infektionen der Atemwege
- Infektionen
- RNA-Virusinfektionen
- Viruserkrankungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Pneumonie, viral
- Lungenentzündung
- Coronavirus-Infektionen
- Coronaviridae-Infektionen
- Nidovirales-Infektionen
- COVID-19
- pädiatrisches Multisystem-Entzündungssyndrom, COVID-19-assoziiert
Andere Studien-ID-Nummern
- KB/86/2025
- 2W9/1/M/MGN25 (Andere Zuschuss-/Finanzierungsnummer: Medical University of Warsaw)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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