The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 入组人数
- 122
- 主要终点
- the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus
研究概览
简要总结
This study is designed to validate the hypothesis that the treatment of rosuvastatin could increase the score of Calcification of Coronary artery(CAC) density in coronary artery disease(CAD) patients with diabetes mellitus.CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
详细描述
Calcification of atherosclerotic plaque is a complicated and organic active process, which is one of the main pathologic features of atherosclerosis. Widely coverage of CAC is correlated with the greater likelihood of coronary events.With the increasing density of CAC, the risk of cardiovascular disease (CVD) declines.Some studies showed that the calcified plaque in stable CHD is denser.
Statins are widely used in the treatment of atherosclerotic cardiovascular disease. Treatment of statins may increase the density score of CAC, thus, promote the unstable atherosclerotic plaque to the stable plaque.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Male and female adults aged 18-70 years old
- •CHD patients without stent implantation determined by coronary angiography or coronary CT examination;
- •Combined with type 2 diabetes: HbA1c≥6.5%, FPG≥7.0mmol/L, 2h blood glucose≥11.1mmol/L
- •Patients who confirmed CAC(Agatston score ≥50,measured by 64 row spiral CT6)
排除标准
- •CHD Patients plan to recieve coronary stenting implantation or coronary artery bypass grafting;
- •Patients combined with severe pulmonary, liver and kidney dysfunction
- •Classed as III-IV grade of New York Heart Association functional
- •Pregnancy test was positive，lactation woman and in women of child-bearing potential not using appropriate contraceptive measures.
- •Life expectancy within 24 months or less
- •Patients combined valvular heart disease and cardiomyopathy
- •Patients combined cancer
- •Patients with atrial fibrillation
- •Patients who is allergic to statins
- •Patients with myopathy
- •Patients with active liver disease
研究组 & 干预措施
CAD+DM
Using self controlled study to validate the hypothesis that the treatment of rosuvastatin could increase the score of CAC density in CAD patients with diabetes mellitus.
干预措施: rosuvastatin (Drug)
结局指标
主要结局
the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus
时间窗: 24 months
次要结局
- the level of serum sclerostin in CAD patients with diabetes mellitus(24months)
- the volume score of CAC in CAD patients with diabetes mellitus(24 months)
研究者
Guo Sheng Fu
MD/PhD
Sir Run Run Shaw Hospital