Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305201
Status:
WITHDRAWN
Last Update Posted:
2016-05-24
First Post:
2006-03-20
Brief Title:
Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease
Status:
WITHDRAWN
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to lack of study participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease and if this condition can be modified by treatment with statins
Detailed Description:
Kawasaki disease KD in its acute phase produces endothelial inflammation that can lead to dilatation and aneurysms of coronary and peripheral arteries This initial injury leads to persistent endothelial dysfunction several years after having the disease As a consequence these patients may have a higher cardiovascular risk than general population Studies with HMG-CoA reductase inhibitors statins have suggested that these have an anti-inflammatory effect over the endothelium that may be independent of its lipid-lowering effects The hypothesis of this study is that KD produces endothelial dysfunction that is persistent years after acute disease and that this dysfunction can be modified by treatment with statinsThe study consists of two phases On the first we will perform ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery and evaluate other cardiovascular risk markers in patients and healthy controls On the second phase patients with history of Kawasaki disease will be randomized and allocated to treatment with Pravastatin or placebo after which a new evaluation of flow-mediated dilation of the brachial artery and cardiovascular risk markers will be performed
Comparisons Children older than 8 years of age with history of Kawasaki disease more than 12 months before enrollment compared with paired by age children without history of KD or other cardiovascular risk factors
Comparisons Children older than 8 years of age with history of Kawasaki disease more than 12 months before enrollment compared with paired by age children without history of KD or other cardiovascular risk factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None