NCT06641817

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Sep 2023Dec 2033

Study Start

First participant enrolled

September 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2033

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

October 15, 2024

Status Verified

September 1, 2024

Enrollment Period

9.3 years

First QC Date

October 8, 2024

Last Update Submit

October 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 years after the onset

Study Arms (1)

petients diagnosed with Kawasaki disease

Diagnostic criteria: based on the American Heart Association(AHA) guideline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

From the past to Jaunary 2033, pediatric patients diagnosed with Kawasaki disease were recruited from West China Second University Hospital.

You may qualify if:

  • Patients diagnosed based on the American Heart Association guideline for Kawasaki disease.

You may not qualify if:

  • Patients with a history of congenital heart disease, cardiomyopathy.
  • Patients with age over 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Second University Hospital, Sichuan University.

Chengdu, Sichuan, China

Location

Related Publications (6)

  • 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.

    PMID: 37787670BACKGROUND
  • Xie 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.

    PMID: 31548437BACKGROUND
  • Chen 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.

    PMID: 26372452BACKGROUND
  • Vranicar 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.

    PMID: 10818198BACKGROUND
  • Suda 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.

    PMID: 21502578BACKGROUND
  • McCrindle 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.

    PMID: 28356445BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The whole boold including blood cell and plasma will be collected for laboratory and genetic test.

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

September 1, 2023

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

December 31, 2033

Last Updated

October 15, 2024

Record last verified: 2024-09

Locations