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Cardiovascular Assessment 5 Years After MIS-C

2026年6月15日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

90

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰
        • 招聘中
        • Medical University of Warsaw Children's Clinical Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Aortic (central) systolic blood pressure
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Peripheral blood pressure
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月22日

初级完成 (估计的)

2026年10月31日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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