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Clinical Trials/NCT06641817
NCT06641817
Enrolling By Invitation
Not Applicable

An Observed Research: to Assess Kawasaki Disease with Cardiovascular Imaging

West China Second University Hospital1 site in 1 country500 target enrollmentStarted: September 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
West China Second University Hospital
Enrollment
500
Locations
1
Primary Endpoint
Major adverse cardiovascular events

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
West China Second University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ling-Yi Wen

Principal Investigator

West China Second University Hospital

Study Sites (1)

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