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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observed Research: to Assess Kawasaki Disease with Cardiovascular Imaging
- ClinicalTrials.gov ID
- NCT06641817
- Acronym / sponsor ID
- WestChinaSUH2023095-2
- Conditions
- Kawasaki Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| petients diagnosed with Kawasaki disease | – | –Diagnostic criteria: based on the American Heart Association(AHA) guideline |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- From the past to Jaunary 2033, pediatric patients diagnosed with Kawasaki disease were recruited from West China Second University Hospital.
Key inclusion criteria (1 listed)
- Patients diagnosed based on the American Heart Association guideline for Kawasaki disease.
Key exclusion criteria (2 listed)
- Patients with a history of congenital heart disease, cardiomyopathy.
- Patients with age over 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular events
Time frame: 10 years after the onset
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 37787670Kuroda 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.
- Background: PubMed 31548437Xie 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.
- Background: PubMed 26372452Chen 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.
- Background: PubMed 10818198Vranicar 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.
- Background: PubMed 21502578Suda 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.
- Background: PubMed 28356445McCrindle 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kawasaki Disease, run by West China Second University Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 10 years after the onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06641817, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.