Kawasaki DiseaseNCT06641817
The Value of Cardiovascular Imaging in Kawasaki Disease
An observational study of Kawasaki Disease, run by West China Second University Hospital at 1 site in China.
Trial summary
The goal of this observational study is to assess the cardiovascular injury of Kawasaki disease with multi-modal imaging combined with clinical data. During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and genetic tests… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Kawasaki Disease
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: From the past to Jaunary 2033, pediatric patients diagnosed with Kawasaki disease were recruited from West China Second University Hospital.
Who may be able to join
- Patients diagnosed based on the American Heart Association guideline for Kawasaki disease.
Who cannot join
- Patients with a history of congenital heart disease, cardiomyopathy.
- Patients with age over 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Second University Hospital, Sichuan University.
Chengdu, Sichuan
About this study
Official title: An Observed Research: to Assess Kawasaki Disease with Cardiovascular Imaging
The goal of this observational study is to assess the cardiovascular injury of Kawasaki disease with multi-modal imaging combined with clinical data.
During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and genetic tests when hospitalization and follow-up, and the baseline data will be collected at the admission. Some patients will undergo coronary computed tomography angiography (CCTA) or DSA due to the disease progress. All the above examination data and changes will be analyzed to assess the value of cardiovascular imaging in the pathogenesis, diagnosis, and prognosis of Kawasaki disease.
- Conditions
- Kawasaki Disease
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| petients diagnosed with Kawasaki disease | Diagnostic criteria: based on the American Heart Association(AHA) guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Major adverse cardiovascular events including cardiac death, transient ischemic attack or stroke, myocardial infarction, arrhythmia, heart failure, severe valvular disease, percutaneous coronary intervention, coronary artery bypass graft, and other cardiovascular surgery.
Measured: 10 years after the onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Jan 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Yi Wen, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641817
- Sponsor's protocol ID
- WestChinaSUH2023095-2
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuroda H, Oguri T, Kamiyama N, Toyoda H, Yasuda S, Imajo K, Suzuki Y, Sugimoto K, Akita T, Tanaka J, Yasui Y, Kurosaki M, Izumi N, Nakajima A, Fujiwara Y, Abe T, Kakisaka K, Matsumoto T, Kumada T. Multivariable Quantitative US Parameters for Assessing Hepatic Steatosis. Radiology. 2023 Oct;309(1):e230341. doi: 10.1148/radiol.230341.
PubMed 37787670Xie LP, Yan WL, Huang M, Huang MR, Chen S, Huang GY, Liu F. Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017. J Epidemiol. 2020 Oct 5;30(10):429-435. doi: 10.2188/jea.JE20190065. Epub 2019 Sep 21.
PubMed 31548437Chen JJ, Ma XJ, Liu F, Yan WL, Huang MR, Huang M, Huang GY; Shanghai Kawasaki Disease Research Group. Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012. Pediatr Infect Dis J. 2016 Jan;35(1):7-12. doi: 10.1097/INF.0000000000000914.
PubMed 26372452Vranicar M, Hirsch R, Canter CE, Balzer DT. Selective coronary angiography in pediatric patients. Pediatr Cardiol. 2000 May-Jun;21(3):285-8. doi: 10.1007/s002460010064.
PubMed 10818198Suda K, Iemura M, Nishiono H, Teramachi Y, Koteda Y, Kishimoto S, Kudo Y, Itoh S, Ishii H, Ueno T, Tashiro T, Nobuyoshi M, Kato H, Matsuishi T. Long-term prognosis of patients with Kawasaki disease complicated by giant coronary aneurysms: a single-institution experience. Circulation. 2011 May 3;123(17):1836-42. doi: 10.1161/CIRCULATIONAHA.110.978213. Epub 2011 Apr 18.
PubMed 21502578McCrindle BW, Rowley AH, Newburger JW, Burns JC, Bolger AF, Gewitz M, Baker AL, Jackson MA, Takahashi M, Shah PB, Kobayashi T, Wu MH, Saji TT, Pahl E; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; and Council on Epidemiology and Prevention. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association. Circulation. 2017 Apr 25;135(17):e927-e999. doi: 10.1161/CIR.0000000000000484. Epub 2017 Mar 29.
PubMed 28356445