Clinical Trial: Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service

Brief Summary: 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 scoring than the risk calculated by the Framingham Risk Score.

Detailed Summary: 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 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.
Sponsor: David Grant U.S. Air Force Medical Center

Current Primary Outcome:

• Prevalence of atherosclerosis [ Time Frame: <7 days ]
  Determine prevalence of atherosclerosis in active duty enlisted military members with 10 or more years of military service and at least one cardiovascular risk factor using coronary artery calcium scoring.
• Rate of reclassification [ Time Frame: <7 days ]
  Assess the rate of reclassification of subjects from one risk category using Framingham Risk Scores (FRS) to another risk category using the results of the Coronary Artery Calcium (CAC) score.
• Compare FRS to the CAC percentage [ Time Frame: < 7 days ]
  Compare FRS to the CAC percentage for age risk score for enlisted subjects with at least 10 years of military service and at least one additional cardiovascular risk factor to determine how well the results correlate with one another.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Compare CAC scores between each group to see if there is an association between categories and formation of calcified plaques [ Time Frame: 15 months ]
  Those meeting the criteria for metabolic syndrome vs. those not meeting criteria
• Compare FRS to CAC cardiovascular risk [ Time Frame: 15 Months ]
  Those meeting the criteria for metabolic syndrome vs. those not meeting criteria
• Compare FRS to CAC Cardiovascular Risk [ Time Frame: 15 Months ]
  Those who lived in the dorms for >5 years compared to those living in the dorms for <5
• Compare FRS to CAC Cardiovascular Risk [ Time Frame: 15 Months ]
  Those with Physical Fitness Test (PFT) failures vs. those without
• Compare FRS to CAC cardiovascular risk [ Time Frame: 15 Months ]
  Number of years of military service in the following groups: 10-14 years, 15-19 years 20-24 years and 25+ years
• Compare FRS to CAC cardiovascular risk [ Time Frame: 15 months ]
  Those with 1 risk factor vs. 2 risk factors, vs. 3 risk factors, vs. 4 risk factors, vs. 5 risk factors (as listed in the inclusion criteria section)
• Compare CAC scores between each group to see if there is an association between categories and formation of calcified plaques [ Time Frame: 15 Months ]
  Those who lived in the dorms for >5 years compared to those living in the dorms for <5
• Compare CAC scores between each group to see if there is an association between categories and formation of calcified plaques [ Time Frame: 15 Months ]
  Those with PT test failures vs. those without
• Compare CAC scores between each group to see if there is an association between categories and formation of calcified plaques [ Time Frame: 15 months ]
  Number of years of military service in the following groups: 10-14 years, 15-19 years 20-24 years and 25+ years
• Compare CAC scores between each group to see if there is an association between categories and formation of calcified plaques [ Time Frame: 15 months ]
  Those with 1 risk factor vs. 2 risk factors, vs. 3 risk factors, vs. 4 risk factors, vs. 5 risk factors

Original Secondary Outcome: Same as current

Information By: David Grant U.S. Air Force Medical Center

Dates:
Date Received: December 9, 2013
Date Started: October 2013
Date Completion:
Last Updated: November 10, 2016
Last Verified: November 2016