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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by David Grant U.S. Air Force Medical Center
Sponsor:
Information provided by (Responsible Party):
David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier:
NCT02009930
First received: December 9, 2013
Last updated: June 11, 2014
Last verified: June 2014

December 9, 2013
June 11, 2014
October 2013
December 2015   (final data collection date for primary outcome measure)
  • Prevalence of atherosclerosis [ Time Frame: <7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT02009930 on ClinicalTrials.gov Archive Site
  • Compare CAC scores between each group to see if there is an association between categories and formation of calcified plaques [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Those meeting the criteria for metabolic syndrome vs. those not meeting criteria
  • Compare FRS to CAC cardiovascular risk [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
    Those meeting the criteria for metabolic syndrome vs. those not meeting criteria
  • Compare FRS to CAC Cardiovascular Risk [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Those with Physical Fitness Test (PFT) failures vs. those without
  • Compare FRS to CAC cardiovascular risk [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Those with 1 risk factor vs. 2 risk factors, vs. 3 risk factors, vs. 4 risk factors, vs. 5 risk factors
Same as current
Not Provided
Not Provided
 
Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service

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.

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.

Observational
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

Active duty military enlisted members with 10 or more years of service

  • Atherosclerosis
  • Plaque, Atherosclerotic
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
September 2016
December 2015   (final data collection date for primary outcome measure)

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

  • Recent significant radiation exposure - PET scan, Nuclear Bone Scan or Nuclear Study, or repeated imaging over the past 12 months for a condition (ex. repeated x-rays for ankle fracture/surgery or repeated abdominal CTs for obstruction, etc.)
  • Females who think they may be pregnant
  • Pregnant females
Both
35 Years and older
Yes
Contact: Melenie Aaron, Coordinator 707-423-3641 melenie.aaron.ctr@us.af.mil
Contact: Audra Mendelsohn, MD 707-423-7249 audra.mendelsohn@us.af.mil
United States
 
NCT02009930
FDG20130024H
Yes
David Grant U.S. Air Force Medical Center
David Grant U.S. Air Force Medical Center
Not Provided
Principal Investigator: Ian Riddock, MD David Grant USAF Medical Center
David Grant U.S. Air Force Medical Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP