EVALUATION OF SIMVASTATIN TREATMENT TO RETARD PROGRESS OF CORONARY CALCIFICATION

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。目的：本研究的目的是探讨螺旋CT(HCT)是否可以用来观察冠状动脉钙化(CAC)的恶化，以及辛伐他汀治疗是否会减缓CAC的进展。研究对象：我们将随机选择80名患者，年龄在21岁到75岁之间，他们有冠状动脉钙化的证据(通过HCT筛查)，而且胆固醇水平高于平均水平，但根据目前的指南，胆固醇水平不足以保证治疗。方法和措施：在适当的饮食咨询后，80名患者将被随机分成两种治疗方案中的一种进行盲法治疗：40 mg滴定至每天80 mg辛伐他汀或安慰剂。对患者进行为期1年的临床随访，分别在基线、1、3、6、9和12个月进行血脂和脂蛋白定量，并在基线、6个月和1年进行冠状动脉钙化量化。主要的结果变量将是一年以上冠状动脉钙化的进展。好处：该计划的目的是开发一种新的微创方法来测试具有降低心脏病发作风险的潜在药物的疗效。如果我们能开发出这样一种新方法，就有可能更快地确定哪些患者将从药物治疗中受益最多。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: The purpose of the study is to see whether helical computed tomography(HCT)can be used to look at heart arteries for worsening of coronary artery calcification(CAC), and whether treatment with simvastatin will slow down the progression of CAC in heart arteries. Subjects: We will randomize 80 patients, ages 21 through 75, with evidence of coronary calcification (by HCT screening exam) and a cholesterol level that is above average but not at a level that would warrant treatment according to current guidelines. Methods and Measures: After appropriate dietary counseling, 80 patients will be randomized to blinded treatment with one of two therapies: 40mg titrated to 80mg of simvastatin daily or placebo. Patients will be followed for 1 year with clinic visits, quantification of plasma lipids and lipoproteins at baseline, 1,3,6,9 and 12 months, and quantification of coronary artery calcification at baseline, 6 months and 1 year. The primary outcome variable will be progression of coronary calcification over one year. Benefits: The aim of this program is to develop a new minimally invasive method for testing efficacy of drugs with potential for reducing the risk of heart attack. If we can develop such a new method, it will be possible to more rapidly identify patients who will benefit most from medications.