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

NCT02009930 | Terminated Results DMC

• 1 other identifier: FDG20130024H
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Plaque, Atherosclerotic

Keywords

Military Active Duty Enlisted; Atherosclerosis; Coronary Artery Calcium (CAC); Cardiovascular; CAC Score; Framingham Score; CT Scan

Outcome Measures

Primary Outcomes (3)

• Prevalence of Atherosclerosis

  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.

  within 10 days of CT scan

• Rate of Reclassification

  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

  within 10 days of CT scan

• Compare FRS to the CAC - At Least One Additional Risk Factor

  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

  within 10 days of CT scan

Secondary Outcomes (10)

• Metabolic Syndrome - Compare FRS to CAC

  within 10 days of CT scan

• Living in the Dorms - Compare FRS to CAC

  within 10 days of CT scan

• Physical Fitness (PT) Failures - Compare FRS to CAC

  within 10 days of CT scan

• Years of Military Service - Compare FRS to CAC

  within 10 days of CT scan

• Additional Cardiovascular Risk Factors - Compare FRS to CAC

  within 10 days of CT scan

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Study Sites (1)

David Grant USAF Medical Center

Travis Air Force Base, California, 94535, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

There were only 3 female participants; therefore, generalizations could not be made for this gender

Results Point of Contact

• Title: Dr. Elijah Burton
• Organization: David Grant Medical Center, Travis Air Force Base

elijah.j.burton2.mil@mail.mil

707-423-7950

Study Officials

• Elijah Burton, MD

  David Grant USAF Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiology Resident

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: November 5, 2013
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Locations

US (1)