Clinical trial NCT02009930: Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
Official title: Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atherosclerosis
Plaque, Atherosclerotic
Keywords: Military Active Duty Enlisted
Atherosclerosis
Coronary Artery Calcium (CAC)
Cardiovascular
CAC Score
Framingham Score
CT Scan
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2013-12-12
Enrollment: 112
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active duty military enlisted 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 (CAC) scoring than the risk calculated by the Framingham Risk Score.

Detailed description: 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.

Eligibility criteria: INCLUSION Criteria:

Active Duty Military Members with at least 10 years of service

Enlisted Rank

Males 35 years and older OR Females 45 years and older (please note the age difference is due to the fact that female plaque formation with calcification has been shown to lag that of males by about 10 years)

One or More of the Following Risk Factors:

Smoker - at least 5 pack years in the past 5 years (pack year = number of packs per day number of years of smoking)

Diabetic (Fasting glucose of \>125 mg/dL on two or more blood draws, or Random Blood Glucose of \>200 mg/dL on a single blood draw, or Hemoglobin A1C \>6.5%, or previous diagnosis of diabetes listed in the subject's medical record) or Pre-diabetic (Fasting glucose \>100 on two or more blood draws or Hgb A1C 5.7-6.4)

Hypertension (Systolic BP \> 140 or Diastolic BP \>90 or on blood pressure medications or diagnosis of hypertension in medical record)

Waist Circumference \> 40 inches for males or \>35 inches for females

Hyperlipidemia (LDL\>130, HDL\<40 for males, HDL \<50 for females, Triglycerides \>200, on lipid lowering medications and/or diagnosis of hyperlipidemia in medical record)

EXCLUSION Criteria:

Males \<35 years old

Women \<45 years old (please note the age difference is due to the fact that female plaque formation with calcification has been shown to lag that of males by about 10 years)

Officer Rank - officers are excluded as we are looking at the enlisted culture in the military.

History of any of the following:

Coronary Artery Disease (CAD)

Coronary Artery Bypass Grafting (CABG)

Myocardial Infarction (MI)

Percutaneous Intervention/Stent Placement (PCI)

Angina

Radiotherapy (external beam, brachytherapy, radiopharmaceutical)

Under the care of any of the following types of providers in the past 12 months (As these subjects are at greater risk of having had significant radiation exposure to the chest over the past 12 months):

Radiation/Medical Oncologist

Interventional Radiologist

Cardiologist

Cardiothoracic Surgeon

Vascular Surgeon

Females who think they may be pregnant

Pregnant females

Primary outcomes:
measure: Prevalence of Atherosclerosis
timeFrame: within 10 days of CT scan
measure: Rate of Reclassification
timeFrame: within 10 days of CT scan
measure: Compare FRS to the CAC - At Least One Additional Risk Factor
timeFrame: within 10 days of CT scan
Secondary outcomes:
measure: Metabolic Syndrome - Compare FRS to CAC
timeFrame: within 10 days of CT scan
measure: Living in the Dorms - Compare FRS to CAC
timeFrame: within 10 days of CT scan
measure: Physical Fitness (PT) Failures - Compare FRS to CAC
timeFrame: within 10 days of CT scan
measure: Years of Military Service - Compare FRS to CAC
timeFrame: within 10 days of CT scan
measure: Additional Cardiovascular Risk Factors - Compare FRS to CAC
timeFrame: within 10 days of CT scan
measure: Metabolic Syndrome - CAC
timeFrame: within 10 days of CT scan
measure: Living in the Doors - CAC
timeFrame: within 10 days of CT scan
measure: PT Failures - CAC
timeFrame: within 10 days of CT scan
measure: Years of Military Service - CAC
timeFrame: within 10 days of CT scan
measure: Additional Risk Factors - CAC
timeFrame: within 10 days of CT scan
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant USAF Medical Center
state: California
Study officials:
affiliation: David Grant USAF Medical Center
name: Elijah Burton, MD
role: PRINCIPAL_INVESTIGATOR
References: