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Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities

Application of Statins in Long-term Treatments of Kawasaki Disease Complicated With Severe Coronary Artery Abnormalities in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03915795
Enrollment
30
Registered
2019-04-16
Start date
2019-08-20
Completion date
2023-12-30
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Abnormalities, Kawasaki Disease

Keywords

Kawasaki Disease, coronary artery abnormalities, statins

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.

Detailed description

Kawasaki disease (KD) is an acute self-limited vasculitis and occurs almost exclusively in childhood. It predominantly affects medium-sized arteries, most commonly the coronary arteries. Although the use of intravenous immunoglobulin (IVIG) has obviously decreased the incidence of coronary arteries (CA) abnormalities, still a part of KD children occur CA abnormalities, even medium, large or giant aneurysms. The coronary aneurysms can develop to thrombus and arterial stenosis, which may cause severe cardiac events, for example, myocardial infarction. It is the main cause of disability and death in KD children. Now KD has been the leading cause of acquired heart disease in children. Some studies found that ongoing vascular chronic inflammation and oxidative stress persisted in the long-term KD vasculopathy. Endothelial dysfunction, increased stiffness, and intima-media thickening have been noted in both affected coronary arteries and systemic arteries. Statins (hydroxymethylglutaryl coenzyme-A reductase inhibitors) not only are a kind of drug lowering low-density lipoprotein cholesterol, but also have been reported to have potentially beneficial pleiotropic effects on inflammation, endothelial function, oxidative stress, platelet aggregation, coagulation, and fibrinolysis. They have been the cornerstone of therapy for the primary and secondary prevention of atherosclerotic cardiovascular events in adults. In recently years, statins have been considered to be used in KD children with coronary aneurysms. Several short-term small studies in such patients treated with statins have shown reductions in high-sensitivity CRP, improved endothelial function and statins' safety in children. The American Heart Association (AHA) scientific statement on KD published in 2017 suggests that empirical treatment with low-dose statin may be considered for KD patients with past or current aneurysms, regardless of age or sex. However, the current clinical data about the use of statins in KD children is still very rare. The published researches mainly focused on the endothelial function of peripheral arteries but the effects of statins on CAs and cardiac events have not been included. Therefore, more studies are needed to conform statins' feasibility and safety in children and its clinical application value. In this study, we will recruit KD children complicated with severe CA abnormalities. These children will be given statins for one year besides other routine treatments. The coronary assessments, clinical and laboratory indexes will be followed up to study the effects of statins on long-term chronic inflammation, CA abnormalities and clinical cardiac events. At the same time, the clinical and laboratory indexes correlated to the side-effects will be monitored regularly to investigate the feasibility and safety of statins in KD children.

Interventions

None listed

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* \>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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change of coronary artery abnormalities measured by echocardiographyAt baseline and one year after taking statinInternal lumen diameters(mm) and Z score of coronary artery abnormalities measured by echocardiography

Secondary

MeasureTime frameDescription
Change of LDL-CAt baseline and one year after taking statinDecrease in LDL-C(mmol/L)
Change of high-sensitivity C reactive protein (hsCRP)At baseline and one year after taking statinDecrease in hsCRP (mg/L) as a chronic inflammation marker
Assessment of myocardial ischemiaAt baseline and one year after taking statinNew onset or improved manifestation of myocardial ischemia, assessed by EKG/stress EKG, radionuclide myocardial imaging and/or magnetic resonance imaging
Incidence of new-onset cardiovascular eventsOne year after taking statinIncidence of new-onset cardiovascular events including chest tightness, chest pain, angina, myocardial infarction and so on
Incidence of side-effects of statin in KD childrenAt baseline, 3, 6, 9 months and one year after taking statinsIncidences of side-effects including abnormal laboratory indexes (elevated muscle enzyme and liver enzyme), adverse clinical events and growth impacts (weight, height and BMI)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026