Atherosclerosis Clinical Trial
Official title:
Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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