Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities

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Brief Title

Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

Change of coronary artery abnormalities measured by echocardiography

Secondary Outcome

 Change of LDL-C

Condition

Kawasaki Disease



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

25

Start Date

August 20, 2019

Completion Date

December 2021

Primary Completion Date

June 2021

Eligibility Criteria

        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
      

Gender

All

Ages

2 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Fang Liu, MD, +86 21 64932026, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03915795

Organization ID

Statins study in KD


Responsible Party

Sponsor

Study Sponsor

Children's Hospital of Fudan University


Study Sponsor

Fang Liu, MD, Study Director, Children's Hospital of Fudan University


Verification Date

November 2019