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).

Public Health Relevance

Computed tomographic measures of emphysema, airway, and vascular disease in a subset of smokers enrolled in the parent STATCOPE Investigation may allow the identification of which subjects with COPD are at greatest risk for the development of acute exacerbations of disease (AECOPD) as well as cardiovascular events. This may allow heightened awareness of which subjects are at greatest risk for adverse events and allow earlier, more aggressive preventive therapy. (End of Abstract)

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
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Study Section
Special Emphasis Panel (ZHL1-CSR-G (O2))
Program Officer
Punturieri, Antonello
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Brigham and Women's Hospital
United States
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