Computed Tomographic characterization of subjects enrolled in the STATCOPE trial

描述(由申请人提供)：这项辅助研究提案的目的是使用计算机断层成像来确定患有慢性阻塞性肺疾病(COPD)的吸烟者患急性加重疾病(AECOPD)和心血管事件的风险最高。研究人员假设，受试者的肺气肿、呼吸道和血管疾病(通过标准肺功能测试都无法区分)的相对负担都会影响不良事件的风险，并可能对他汀类药物做出不同的反应。最后，假设他汀类药物治疗将缓解与疾病相关的疾病放射学测量的纵向进展。为了进行这项调查，将在400名受试者登记参加家长STATCOPE调查时和研究结束时对他们进行CT扫描。在数据协调中心(DCC)的帮助下，登记将包括200名随机服用安慰剂的受试者和200名随机接受他汀类药物治疗的受试者。通过这种方式，可以检查他汀类药物治疗(及其与CT疾病测量的相互作用)对AECOPD、心血管风险和疾病进展的影响。肺气肿和呼吸道疾病的客观测量将由沃什科博士的实验室进行(研究PI)。动脉粥样硬化性血管疾病的其他客观测量将由布多夫博士的实验室(研究合作研究员)进行。

DESCRIPTION (provided by applicant): The purpose of this ancillary study proposal is to use computed tomographic imaging to identify which smokers with chronic obstructive pulmonary disease (COPD) are at greatest risk for the development of acute exacerbations of disease (AECOPD) and cardiovascular events. The investigators hypothesize that a subject's relative burden of emphysema, airway, and vascular disease (all indiscernible by standard lung function testing) all influence risk of adverse events and may respond differently to statin therapy. Finally, it is hypothesized that statin therapy will mitigate the disease related longitudinal progression of radiographic measures of disease. To perform this investigation, CT scans will be obtained on 400 subjects at their time of enrollment into the parent STATCOPE Investigation and at their study termination. With the assistance of the Data Coordinating Center (DCC) enrollment will include 200 subjects randomized to placebo and 200 subjects randomized to statin therapy. In this way the effect of statin therapy (and its interaction with CT measures of disease) on AECOPD, cardiovascular risk, and disease progression can be examined. Objective measures of emphysema and airway disease will be performed by Dr. Washko's lab (study PI). Additional objective measures of atherosclerotic vascular disease will be performed by Dr. Budoff's lab (study co- investigator).