EARLY ATHEROSCLEROSIS CHANGE IN TWO CLINICAL TRIALS

本提案的主要目标是：1)完成终点 对监测的动脉粥样硬化回归研究(MARS)的分析；以及 2)比较冠状动脉与颈动脉治疗效果的关系。 MARS对冠状动脉和颈动脉治疗效果的关系 降胆固醇动脉粥样硬化研究(CLAD)。火星是一个 血管造影术随机、双盲、安慰剂对照试验 洛伐他汀与饮食配合降脂效果的比较 再加上270名受试者的安慰剂。目标研究人群包括 70岁以下的男性和女性，胆固醇水平从200 至295 mg/dL与两支或两支以上冠状动脉病变 细分市场。随访2次和4次冠状动脉造影术 247名和68名受试者分别在随机化后数年；提供 冠状动脉粥样硬化消退/进展的信息 侵入性损伤。颈动脉超声图像已经在四点被记录下来 215名受试者的每月间隔时间最长为四年， 关于动脉粥样硬化消退/进展的信息 (内膜-中层厚度)病变与冠状动脉平行 侵入性损伤。火星的独特特征包括：1)同时 冠状动脉造影术(通过定量冠状动脉造影术进行评估 (QCA和面板读数)和颈动脉超声检查 200名受试者；2)评估最大脂蛋白和 到目前为止，在血管造影术试验中收集的载脂蛋白数据。这 包括广泛的极低密度脂蛋白、低密度脂蛋白、低密度脂蛋白和高密度脂蛋白亚类以及低密度脂蛋白类型 模式、脂蛋白颗粒和载脂蛋白(包括AI、B、CIII、 和E)；以及，3)评估饮食影响的机会 仅在另一次血管造影术中出现动脉粥样硬化消退/进展 小路，克拉斯。火星和克拉斯的一个独特特征表现出了类似的 对类男性(患有冠脉搭桥术的非吸烟男性)和女性的影响。自.以来 颈动脉内膜-中层厚度、QCA和全球变化评分 被证明可以预测临床冠状动脉事件，了解 这些动脉粥样硬化指标之间的关系可能在 建立颈动脉内膜中层厚度测量作为替代指标 测量冠状动脉粥样硬化。

Primary objectives of this proposal are: 1) To complete end point analysis for the Monitored Atherosclerosis Regression Study (MARS); and 2) To compare coronary versus carotid treatment effect relationships in MARS to coronary versus carotid treatment effect relationships in the Cholesterol Lowering Atherosclerosis Study (CLAD). MARS was a randomized, double-blind, placebo-controlled, angiographic trial comparing the effects of lipid lowering by lovastatin and diet with diet plus placebo in 270 subjects. The target study population consisted of males and females under 70 years of age with cholesterol levels from 200 to 295 mg/dL and coronary artery disease in two or more coronary artery segments. Follow-up coronary angiograms were performed two and four years post-randomization in 247 and 68 subjects, respectively; providing information on atherosclerosis regression/progression of coronary artery intrusive lesions. Carotid ultrasound images have been recorded at four month intervals for periods up to four years in 215 subjects providing information on atherosclerosis regression/progression of pre-intrusive (intima-media thickness) lesions in parallel with coronary artery intrusive lesions. Unique features of MARS include: 1) Simultaneous coronary angiography (evaluated both by quantitative coronary angiography (QCA) and panel-reading) and carotid ultrasonography in a cohort of over 200 subjects; 2) The opportunity to evaluate the largest lipoprotein an apolipoprotein data collected in an angiographic trial to date. This includes extensive VLDL, LDL, IDL, and HDL subclasses as well as LDL type pattern, lipoprotein particles and apolipoprotein (including AI, B, CIII, and E); and, 3) The opportunity to evaluate dietary effects on atherosclerosis regression/progression only in one other angiographic trail, CLAS. A unique feature of MARS and CLAS has shown a similar effect in CLAS-like men (non-smoking men with CABG) and women. Since carotid intima-media thickness, QCA, and global change score have been shown to be predictive of clinical coronary events, understanding the relationship between these atherosclerotic measures may be important in establishing carotid intima-media thickness measurements as a proxy measure for coronary atherosclerosis.