Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities
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|ClinicalTrials.gov Identifier: NCT03915795|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : November 13, 2019
|Condition or disease|
|Kawasaki Disease Coronary Artery Abnormalities|
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|
|Estimated Enrollment :||25 participants|
|Official Title:||Application of Statins in Long-term Treatments of Kawasaki Disease Complicated With Severe Coronary Artery Abnormalities in Children|
|Actual Study Start Date :||August 20, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
- Change of coronary artery abnormalities measured by echocardiography [ Time Frame: At baseline and one year after taking statin ]Internal lumen diameters(mm) and Z score of coronary artery abnormalities measured by echocardiography
- Change of LDL-C [ Time Frame: At baseline and one year after taking statin ]Decrease in LDL-C(mmol/L)
- Change of high-sensitivity C reactive protein (hsCRP) [ Time Frame: At baseline and one year after taking statin ]Decrease in hsCRP (mg/L) as a chronic inflammation marker
- Assessment of myocardial ischemia [ Time Frame: At baseline and one year after taking statin ]New 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 events [ Time Frame: One year after taking statin ]Incidence of new-onset cardiovascular events including chest tightness, chest pain, angina, myocardial infarction and so on
- Incidence of side-effects of statin in KD children [ Time Frame: At baseline, 3, 6, 9 months and one year after taking statins ]Incidences of side-effects including abnormal laboratory indexes (elevated muscle enzyme and liver enzyme), adverse clinical events and growth impacts (weight, height and BMI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915795
|Contact: Chen Chu, MD||+86 21 firstname.lastname@example.org|
|Contact: Fang Liu, MD||+86 21 email@example.com|
|Children's Hospital of Fudan University||Recruiting|
|Shanghai, Shanghai, China, 201102|
|Contact: Fang Liu, MD +86 21 64932800 firstname.lastname@example.org|
|Study Director:||Fang Liu, MD||Children's Hospital of Fudan University|