NCT00920101Unknown4 期
Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging
National Defense Medical College, Japan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques
研究概览
简要总结
The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with accumulation of FDG-PET in carotid artery or aorta
排除标准
- •LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl
- •subjects currently taking HMG CoA-reductase (Statins) or fibrates
- •symptomatic coronary artery diseases
- •symptomatic cerebrovascular diseases
- •subjects suffered from myocardial infarction or stroke within 6 months
- •subjects underwent percutaneous vascular interventions or vascular operations within 6 months
- •diabetic patients with poor glycemic control (HbA1c>8.5)
- •hypertensive patients with poor blood pressure control
- •subjects with neoplasms
- •subjects with systemic inflammatory diseases
研究组 & 干预措施
Atorvastatin
Active Comparator
干预措施: Atorvastatin (Drug)
Lifestyle counseling
Placebo Comparator
Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study.
干预措施: Lifestyle counseling (Behavioral)
结局指标
主要结局
Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques
时间窗: Baseline and 3 months after intervention
次要结局
- Flow-mediated vasodilation of brachial artery determined by ultrasonography(Baseline and 3 months after intervention)
- Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1(Baseline and 3 months after intervention)
- Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine(Baseline and 3 months after intervention)
- Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography(Baseline and 3 months after intervention)
- Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides(Baseline and 3 months after intervention)
研究者
Makoto Ayaori
Assistant Professor
National Defense Medical College, Japan
研究点 (1)
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