- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
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
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Weronika Woźniak-Szewczyk, MD
- 전화번호: +48 22 317 9231
- 이메일: wwozniakszewczyk@gmail.com
연구 연락처 백업
- 이름: Magdalena Okarska-Napierała, MD PhD
- 전화번호: +48 22 317 9231
- 이메일: magdalena.okarska-napierala@wum.edu.pl
연구 장소
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, 폴란드
- 모병
- Medical University of Warsaw Children's Clinical Hospital
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연락하다:
- Weronika Woźniak-Szewczyk, MD
- 전화번호: +48 22 317 9231
- 이메일: wwozniakszewczyk@gmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
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:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Aortic (central) systolic blood pressure
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peripheral blood pressure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
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At the study visit, approximately 5 years after MIS-C diagnosis
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- KB/86/2025
- 2W9/1/M/MGN25 (기타 보조금/기금 번호: Medical University of Warsaw)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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