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
  Purpose

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.


Condition
Atherosclerosis
Plaque, Atherosclerotic

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service

Resource links provided by NLM:


Further study details as provided by David Grant U.S. Air Force Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 180
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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 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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009930

Contacts
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

Locations
United States, California
David Grant USAF Medical Center Recruiting
Travis AFB, California, United States, 94535
Contact: Melenie Aaron, Coordinator    707-423-3641    melenie.aaron.ctr@us.af.mil   
Contact: Rebecca Rodriguez, Coordinator    707-816-5723    Rebecca.rodriguez.5.ctr@us.af.mil   
Principal Investigator: Ian Riddock, MD         
Sub-Investigator: Audra Mendelsohn, MD         
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
Principal Investigator: Ian Riddock, MD David Grant USAF Medical Center
  More Information

No publications provided

Responsible Party: David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT02009930     History of Changes
Other Study ID Numbers: FDG20130024H
Study First Received: December 9, 2013
Last Updated: June 11, 2014
Health Authority: United States: Federal Government

Keywords provided by David Grant U.S. Air Force Medical Center:
Enlisted military members
CAC
Coronary Artery Calcium
Cardiovascular

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014