Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET|
- Plaque Inflammation [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]Change in plaque inflammation was assessed by changes in the plaque SUV.
- Circulating Inflammation Marker [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]Change in circulating hsCRP levels
|Study Start Date:||September 2004|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Experimental: Simvastatin group
Patients with FDG-positive plaque who received simvastatin and diet therapy
simvastatin 5-10 mg/day
Other Name: control
No Intervention: Control group
Patients FDG-positive plaque who received diet therapy alone
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114504
|Kurume University Hospital|
|Kurume, Japan, 830-0011|
|Principal Investigator:||Hisashi Kai, MD, PhD||The Third Department of Internal Medicine, Kurume University|