- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02009930
Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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Travis Air Force Base, California, United States, 94535
- David Grant USAF Medical Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Atherosclerosis
Time Frame: within 10 days of CT scan
|
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
Time Frame: within 10 days of CT scan
|
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
Time Frame: within 10 days of CT scan
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Syndrome - Compare FRS to CAC
Time Frame: within 10 days of CT scan
|
Compare FRS category and CAC risk category for those meeting and not meeting criteria for metabolic syndrome.
Calculate Fisher's Exact test statistic and associated p values to look at the relationship between the presence/absence of metabolic syndrome and the FRS and CAC risk category.
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
|
Living in the Dorms - Compare FRS to CAC
Time Frame: within 10 days of CT scan
|
Compare FRS category to CAC risk category for those who lived in the dorms > 5 years and < 5 years.
Calculate Fisher's Exact test statistic and associated p values to look at the relationship between those who lived in the dorms > 5 years and < 5 years and the FRS and CAC risk category.
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
|
Physical Fitness (PT) Failures - Compare FRS to CAC
Time Frame: within 10 days of CT scan
|
Compare FRS category to CAC risk category for those with and without PT failures.
Calculate Fischer's Exact test statistic and associated p values to look at the relationship between those with and without PT failures and the FRS and CAC risk category.
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
|
Years of Military Service - Compare FRS to CAC
Time Frame: within 10 days of CT scan
|
Compare FRS category to CAC risk category for those with 10-14, 15-19, 20-24 and 25+ years of military service.
Calculate Fisher's Exact test statistic and associated p values to look at the relationship between those with 10-14, 15-19, 20-24 and 25+ years of military service and FRS & CAC risk category.
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 and total cholesterol levels, 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
|
Additional Cardiovascular Risk Factors - Compare FRS to CAC
Time Frame: within 10 days of CT scan
|
Compare FRS category to CAC risk category for those with 1 risk factor (RF), vs 2 RF, vs 3 RF, vs 4 RF, vs 5 CV risk factors.
Calculate Fisher's Exact test statistic and associated p values to look at the relationship between those with 1 RF, vs 2 RF, vs 3 RF, vs 4 RF, vs 5 CV RF and the FRS & CAC risk category.
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 and total cholesterol levels, 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
|
Metabolic Syndrome - CAC
Time Frame: within 10 days of CT scan
|
Compare CAC risk category between two groups, those that meet criteria for metabolic syndrome and those that do not, to see if there is an association between the groups and CAC risk category.
The number of participants in each risk category will be added.
Then the total number for each group will be used to calculate the correlation using Fisher's Exact test and reported as a p value.
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, high, very high.
Low risk is the best outcome, and very high risk is the worst
|
within 10 days of CT scan
|
Living in the Doors - CAC
Time Frame: within 10 days of CT scan
|
Compare CAC risk category between two groups, those who lived in the dorm for > 5 years and < 5 years, to see if there is an association between the groups and CAC risk category.
The number of participants in each risk category will be added.
Then the total number for each group will be used to calculate the correlation using Fisher's Exact test and reported as a p value.
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, high, very high.
Low risk is the best outcome, and very high risk is the worst outcome
|
within 10 days of CT scan
|
PT Failures - CAC
Time Frame: within 10 days of CT scan
|
Compare CAC risk category between two groups, those with and without a PT failures, to see if there is an association between the groups and CAC risk category.
The number of participants in each risk category will be added.
Then the total number for each group will be used to calculate the correlation using Fisher's Exact test and reported as a p value.
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.
Low risk is the best outcome, and very high risk is the worst outcome
|
within 10 days of CT scan
|
Years of Military Service - CAC
Time Frame: within 10 days of CT scan
|
Compare CAC risk category among groups, those with 10-14, 15-19, 20-24, and 25+ years of military service, to see if there is an association between overall years of military service and CAC risk category.
The number of participants in each risk category will be added.
Then the total number for each group will be used to calculate the correlation using Fisher's Exact test and reported as a p value.
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.
Low risk is the best outcome, and very high risk is the worst outcome
|
within 10 days of CT scan
|
Additional Risk Factors - CAC
Time Frame: within 10 days of CT scan
|
Compare CAC risk category among groups, those with 1 risk factor (RF) vs. 2 RF, vs 3 RF, vs 4 RF, vs 5 RF (as listed in the inclusion criteria), to see if there is an association between the groups and CAC risk category.
The number of participants in each risk category will be added.
Then the total number for each group will be used to calculate the correlation using Fisher's Exact test and reported as a p value.
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.
Low risk is the best outcome, and very high risk is the worst outcome
|
within 10 days of CT scan
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elijah Burton, MD, David Grant USAF Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDG20130024H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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