Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities
Condition: Kawasaki Disease; Coronary Artery Abnormalities
MeSH terms: Mucocutaneous Lymph Node Syndrome; Congenital Abnormalities
Study type: Observational

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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The KD children admitted to the Cardiology ward in Children's Hospital of Fudan University,
        Shanghai, China
      
Keywords: Kawasaki Disease; coronary artery abnormalities; statins