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临床试验/NCT00920101
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

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

发起方
National Defense Medical College, Japan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Makoto Ayaori

Assistant Professor

National Defense Medical College, Japan

研究点 (1)

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