Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
This trial is active, not recruiting.
|Treatment||statins (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, or rosuvastatin)|
|Start date||September 2004|
|End date||April 2007|
|Trial size||1000 participants|
|Trial identifier||NCT00114504, KurumeU-2416|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
attenuation of plaque inflammation (decrease in plaque SUV) at 3 and 12 months; cardiovascular events at 1 and 3 years
time frame: 3 years
attenuation of circulating inflammation markers at 3 and 12 months
time frame: 1 year
all cause death at 1 and 3 years; changes in carotid plaque index and plaque thickness
time frame: 3 years
Male or female participants from 30 years up to 80 years old.
Inclusion Criteria: - Protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound. - Protocol 2: patients who underwent FDG-PET for cancer screening and had vascular FDG uptakes Exclusion Criteria: - Active inflammatory diseases - Dyslipidemia under medications - Uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases - Known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases
|Official title||Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-Inflammatory Effects of Statins on Plaque Inflammation by FDG-PET|
|Principal investigator||Hisashi Kai, MD, PhD|
|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. Comparisons: Patients with FDG-positive plaque, compared to patients with plaque but not with FDG uptake. Patients with FDG-positive plaque receiving statin therapy, compared to patients with FDG-positive plaque receiving diet management therapy.|
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