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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
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

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.

Condition or disease
Kawasaki Disease Coronary Artery Abnormalities

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change of LDL-C [ Time Frame: At baseline and one year after taking statin ]
    Decrease in LDL-C(mmol/L)

  2. 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

  3. 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

  4. 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

  5. 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)



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The KD children admitted to the Cardiology ward in Children's Hospital of Fudan University, Shanghai, China
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

Information from the National Library of Medicine

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


Contacts
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Contact: Chen Chu, MD +86 21 64932026 chickenchu@163.com
Contact: Fang Liu, MD +86 21 64932800 liufang@fudan.edu.cn

Locations
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China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Fang Liu, MD    +86 21 64932800    liufang@fudan.edu.cn   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Director: Fang Liu, MD Children's Hospital of Fudan University
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03915795    
Other Study ID Numbers: Statins study in KD
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
Kawasaki Disease
coronary artery abnormalities
statins
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Congenital Abnormalities
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases