Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
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|ClinicalTrials.gov Identifier: NCT00114504|
Recruitment Status : Completed
First Posted : June 16, 2005
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Drug: simvastatin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2009|
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
- Plaque Inflammation [ Time Frame: Baseline, 3 months ]Change in plaque inflammation was assessed by changes in the plaque SUV.
- Circulating Inflammation Marker [ Time Frame: Baseline, 3 months ]Change in circulating hsCRP levels
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114504
|Kurume University Hospital|
|Kurume, Japan, 830-0011|
|Principal Investigator:||Hisashi Kai, MD, PhD||The Third Department of Internal Medicine, Kurume University|