Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114504
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2005-06-15
Brief Title:
Detection of Plaque Inflammation by Positron Emission Tomography PET-Effects of Simvastatin on Plaque Inflammation
Sponsor:
Kurume University
Organization:
Kurume University
Study Overview
Official Title:
Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation The usefulness of FDG-PET in risk stratification is also investigated
Detailed Description:
There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque However currently no non-invasive method is available for detecting plaque inflammation in clinical practice FDG-PET can visualize activated metabolic levels of not only tumor cells but also inflammatory cells Thus it is possible that FDG-PET can detect atherosclerotic plaque inflammation and that if so FDG-PET can monitor the direct effect of statins on plaque inflammation Additionally monitoring the plaque inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients
Originally we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake patients with FDG-positive plaque receiving statin therapy and patients with FDG-positive plaque receiving diet management therapy However because patient number enrolled in the study was too small the comparison was performed between FDG-positive patients with and without any statin therapy
Originally we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake patients with FDG-positive plaque receiving statin therapy and patients with FDG-positive plaque receiving diet management therapy However because patient number enrolled in the study was too small the comparison was performed between FDG-positive patients with and without any statin therapy
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