Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Rate of Reclassification
研究概览
简要总结
Hypothesis: Enlisted military members with 10 or more years of service and at least one cardiovascular risk factor will demonstrate a higher risk of future cardiac events as assessed by coronary artery calcium (CAC) scoring than the risk calculated by the Framingham Risk Score.
详细描述
While the military is making strides towards improving the health and habits of service members, there are many aspects of the military culture that negatively affect the cardiovascular health of military members. Smoking/tobacco use, poor eating habits with Meals Ready-to-eat (MRE) and ready access to fast food establishments on base, inconsistent exercise, the socioeconomic status of enlisted members and the stress of deployment are all factors that contribute to increased risk of cardiovascular disease during military service. Currently the calculation of a patient's Framingham risk score is the most commonly used method of calculating a patient's cardiovascular risk, and this calculation is based on age, smoking history, blood pressure, and lab values and compares it to a general population's risk. By the use of a cardiac computerized topography (CT) scan, a Coronary Artery Calcium (CAC) score can be calculated and used to estimate the degree of atherosclerosis already present in each patient's coronary arteries, and thus establishing their risk of future cardiovascular events. CAC scoring is a more patient-specific way of identifying cardiovascular risk. The purpose of this study is to assess the prevalence of atherosclerosis in enlisted military members with at least 10 years of service and one or more cardiovascular risk factor and to determine if their risk of a cardiovascular event is higher than predicted by the Framingham score. If CAC scoring is demonstrated to be more accurate, particularly if it is more likely to detect risk, it may be used in the future to better risk stratify this population of the military. The CAC results in patients could also be a motivating factor to create changes in the military culture to attempt to mitigate these risks and create a healthier fighting force.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of Reclassification
时间窗: within 10 days of CT scan
Percent/Number of subject that were reclassified from FRS to CAC risk category using CAC scores. The CAC risk category (scale) = CAC score (estimated degree of calcium in coronary arteries, a number) + percentage by age to establish risks of future CV events. There are 5 risk categories: low, low - moderate, moderate - high, very high. The Framingham risk category (scale) = FRS to estimate the risk of a CV event over the next 10 years. The FRS uses age, systolic blood pressure, high-density lipoprotein (HDL) cholesterol level, total cholesterol level, and smoking status to create a score that is converted into a 10-year CV disease risk % that correlates into a risk category: low, moderate, moderate - high risk, very high. For both scales, low is the best and very high is the worst outcome
Compare FRS to the CAC - At Least One Additional Risk Factor
时间窗: within 10 days of CT scan
Compare FRS risk category to CAC risk category for enlisted subjects with at least 10 years of service and at least one additional CV risk factor to determine how well the results correlate with one another using the Spearman's Rank Correlation Coefficient. The CAC risk category (scale) = CAC score (estimated degree of calcium in coronary arteries, a number) + percentage by age to establish risks of future CV events. There are 5 risk categories: low, low - moderate, moderate - high, very high. The Framingham risk category (scale) = FRS to estimate the risk of a CV event over the next 10 years. The FRS uses age, systolic blood pressure, high-density lipoprotein (HDL) cholesterol level, total cholesterol level, and smoking status to create a score that is converted into a 10-year CV disease risk % that correlates into a risk category: low, moderate, moderate - high risk, very high. For both scales, low is the best and very high is the worst outcome
Prevalence of Atherosclerosis
时间窗: within 10 days of CT scan
Percent of active duty enlisted military members with 10 or more years of military service determined to have a prevalence of atherosclerosis based on CAC risk category. The CAC risk category (scale), is derived from the CAC score (i.e., an estimate of the degree of atherosclerosis present in each participant's coronary arteries, reported as a number), and percentage by age to establish risk of future CV events. There are 5 risk categories: Low risk = CAC of 0 and no cardiovascular (CV) risk factors, Low - Moderate risk = CAC of 0 with CV risk factors, Moderate - High risk: CAC 1-100 and percentile for age \<75%, High risk = CAC 100-399 or percentile for age \>75%, Very high risk = CAC \>100 and percentile for age \>90% or CAC \>400". Low risk is the best outcome, and very high risk is the worst.
次要结局
- Physical Fitness (PT) Failures - Compare FRS to CAC(within 10 days of CT scan)
- Living in the Dorms - Compare FRS to CAC(within 10 days of CT scan)
- Additional Cardiovascular Risk Factors - Compare FRS to CAC(within 10 days of CT scan)
- Metabolic Syndrome - Compare FRS to CAC(within 10 days of CT scan)
- Additional Risk Factors - CAC(within 10 days of CT scan)
- Years of Military Service - Compare FRS to CAC(within 10 days of CT scan)
- PT Failures - CAC(within 10 days of CT scan)
- Years of Military Service - CAC(within 10 days of CT scan)
- Metabolic Syndrome - CAC(within 10 days of CT scan)
- Living in the Doors - CAC(within 10 days of CT scan)
研究者
Elijah Burton
Radiology Resident
David Grant U.S. Air Force Medical Center