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Cardiovascular Assessment 5 Years After MIS-C

15 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

90

Contatti e Sedi

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Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia
        • Reclutamento
        • Medical University of Warsaw Children's Clinical Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

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Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Aortic (central) systolic blood pressure
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peripheral blood pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 novembre 2025

Completamento primario (Stimato)

31 ottobre 2026

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

15 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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