Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities

NCT03915795 | Completed

• 1 other identifier: Statins study in KD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of statins on chronic inflammation, coronary artery abnormalities and clinical cardiac events in long-term KD children complicated with severe coronary artery abnormalities, and the feasibility and safety of statins in treatment of KD children.

Conditions

Kawasaki Disease; Coronary Artery Abnormalities

Keywords

Kawasaki Disease; coronary artery abnormalities; statins

Outcome Measures

Primary Outcomes (1)

• Change of coronary artery abnormalities measured by echocardiography

  Internal lumen diameters(mm) and Z score of coronary artery abnormalities measured by echocardiography

  At baseline and one year after taking statin

Secondary Outcomes (5)

• Change of LDL-C

  At baseline and one year after taking statin

• Change of high-sensitivity C reactive protein (hsCRP)

  At baseline and one year after taking statin

• Assessment of myocardial ischemia

  At baseline and one year after taking statin

• Incidence of new-onset cardiovascular events

  One year after taking statin

• Incidence of side-effects of statin in KD children

  At baseline, 3, 6, 9 months and one year after taking statins

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The KD children admitted to the Cardiology ward in Children's Hospital of Fudan University, Shanghai, China

You may qualify if:

• \>3 months after the onset of KD currently complicated with severe coronary artery abnormalities (medium coronary aneurysms or more severe) The follow-up can be achievable All included children's guardian are required to sign the informed consent form

You may not qualify if:

• The KD children currently complicated with mild coronary artery abnormalities (small aneurysms or only dilation) The children's age \<2 ys The children's guardian don't agree to sign the informed consent

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fang Liu, MD

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 16, 2019
• Study Start: August 20, 2019
• Primary Completion: January 31, 2023
• Study Completion: December 30, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)