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Cardiovascular Assessment 5 Years After MIS-C

2026년 6월 15일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

90

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, 폴란드
        • 모병
        • Medical University of Warsaw Children's Clinical Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Aortic (central) systolic blood pressure
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Peripheral blood pressure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 11월 22일

기본 완료 (추정된)

2026년 10월 31일

연구 완료 (추정된)

2027년 3월 31일

연구 등록 날짜

최초 제출

2026년 6월 15일

QC 기준을 충족하는 최초 제출

2026년 6월 15일

처음 게시됨 (실제)

2026년 6월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 15일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

SARS-CoV-2 감염에 대한 임상 시험

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