Computed Tomographic characterization of subjects enrolled in the STATCOPE trial

参加 STATCOPE 试验的受试者的计算机断层扫描特征

• 批准号: 8628867
• 负责人: George R Washko
• 金额: $ 43.38万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-07 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8628867
• 关键词: Acute; Acute Disease; Adverse event; Affect; Ancillary Study; Atherosclerosis; Awareness; Bronchiectasis; C-reactive protein; Cardiovascular system; Cause of Death; Cessation of life; Chronic Obstructive Airway Disease; Clinical Research; Data Coordinating Center; Development; Disease; Disease Progression; Double-Blind Method; Enrollment; Event; Fasting; Frequencies; Funding; Health; Heterogeneity; Image; Intervention; Investigation; Linear Models; Lipids; Lung; Lung volume reduction surgery; Measures; Morbidity - disease rate; Outcome; Oxygen; Parents; Persons; Pharmaceutical Preparations; Placebo Control; Placebos; Preventive; Property; Pulmonary Emphysema; Pulmonary function tests; Randomized; Relative (related person); Research; Research Personnel; Respiratory physiology; Risk; Sampling; Serum Markers; Severities; Simvastatin; Smoker; Smoking; Testing; Thick; Time; United States; Vascular Diseases; Visual; X-Ray Computed Tomography; abstracting; base; cardiovascular risk factor; cohort; experience; follow-up; mortality; prevent; smoking cessation

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).

描述（由申请方提供）：本辅助研究提案的目的是使用计算机断层扫描成像来确定哪些慢性阻塞性肺疾病（COPD）吸烟者发生疾病急性加重（AECOPD）和心血管事件的风险最大。研究人员假设，受试者的肺气肿、气道和血管疾病的相对负担（所有这些都通过标准肺功能测试难以辨别）都会影响不良事件的风险，并且可能对他汀类药物治疗有不同的反应。最后，假设他汀类药物治疗将减轻疾病放射学测量的疾病相关纵向进展。为了进行这项研究，将在400例受试者入组母STATCOPE研究时和研究终止时对其进行CT扫描。在数据协调中心（DCC）的协助下，入组将包括200例随机接受安慰剂治疗的受试者和200例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（及其与疾病CT测量的相互作用）对AECOPD、心血管风险和疾病进展的影响。将由Dr. Washko实验室进行肺气肿和气道疾病的客观测量（研究PI）。动脉粥样硬化性血管疾病的其他客观指标将由Dr. Buffett的实验室（研究合作研究者）进行。