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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02009930
Enrollment
112
Registered
2013-12-12
Start date
2013-11-05
Completion date
2018-07-18
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Plaque, Atherosclerotic

Keywords

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

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.

Interventions

None listed

Sponsors

David Grant U.S. Air Force Medical Center
Lead SponsorFED

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Atherosclerosiswithin 10 days of CT scanPercent 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.
Rate of Reclassificationwithin 10 days of CT scanPercent/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
Compare FRS to the CAC - At Least One Additional Risk Factorwithin 10 days of CT scanCompare 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

Secondary

MeasureTime frameDescription
Years of Military Service - Compare FRS to CACwithin 10 days of CT scanCompare 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
Additional Cardiovascular Risk Factors - Compare FRS to CACwithin 10 days of CT scanCompare 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
Metabolic Syndrome - CACwithin 10 days of CT scanCompare 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
Metabolic Syndrome - Compare FRS to CACwithin 10 days of CT scanCompare 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
PT Failures - CACwithin 10 days of CT scanCompare 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
Years of Military Service - CACwithin 10 days of CT scanCompare 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
Additional Risk Factors - CACwithin 10 days of CT scanCompare 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
Living in the Doors - CACwithin 10 days of CT scanCompare 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
Living in the Dorms - Compare FRS to CACwithin 10 days of CT scanCompare 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
Physical Fitness (PT) Failures - Compare FRS to CACwithin 10 days of CT scanCompare 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

Countries

United States

Participant flow

Recruitment details

5 withdrawn

Participants by arm

ArmCount
Coronary Artery Calcium (CAC) / Framingham Risk Score (FRS)
Coronary Artery Calcium (CAC) scores are reported as a numerical value and a percentage for age that is then regarded in terms of risk categories. The Framingham Risk Score (FRS) is a standard of care for estimating risk of a cardiovascular event over the next 10 years
107
Total107

Withdrawals & dropouts

PeriodReasonFG000
Overall Studywithdrawn5

Baseline characteristics

CharacteristicCoronary Artery Calcium (CAC) / Framingham Risk Score (FRS)
Age, Continuous40.78505 years
STANDARD_DEVIATION 5.037647
More than one cardiovascular risk factor107 Participants
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
104 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 104
other
Total, other adverse events
0 / 104
serious
Total, serious adverse events
0 / 104

Outcome results

Primary

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

Time frame: within 10 days of CT scan

Population: The data is separated into two rows for each arm. Each row corresponds to a group. Participants were placed into one of the two groups based on certain criteria. Each group has a different number of participants analyzed. The total for both groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Compare FRS to the CAC - At Least One Additional Risk Factorat least 1 additional risk factor56 Participants
Coronary Artery Calcium (CAC)Compare FRS to the CAC - At Least One Additional Risk Factorno additional risk factors51 Participants
CAC Risk CategoryCompare FRS to the CAC - At Least One Additional Risk Factorat least 1 additional risk factor56 Participants
CAC Risk CategoryCompare FRS to the CAC - At Least One Additional Risk Factorno additional risk factors51 Participants
Comparison: Compare risk categories (FRS and CAC)p-value: 0.79Spearman's Rank Correlation Coefficient
Primary

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.

Time frame: within 10 days of CT scan

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Prevalence of Atherosclerosis16 Participants
95% CI: [9.4, 22.9]
Primary

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

Time frame: within 10 days of CT scan

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Rate of Reclassificationhigher risk category99 Participants
Coronary Artery Calcium (CAC)Rate of Reclassificationlower risk category5 Participants
Coronary Artery Calcium (CAC)Rate of Reclassificationsame risk category3 Participants
Secondary

Additional Cardiovascular Risk Factors - Compare FRS to CAC

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

Time frame: within 10 days of CT scan

Population: No data collected for this analysis. Due to the relatively small sample size with positive CAC scores, sub-analyses for patients with 2 or more risk factors were not performed. This may be an area for investigation if a larger study population were enrolled

Secondary

Additional Risk Factors - CAC

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

Time frame: within 10 days of CT scan

Population: No data collected for this analysis. Due to the relatively small sample size with positive CAC scores, sub-analyses for patients with 2 or more risk factors were not performed. This may be an area for investigation if a larger study population were enrolled

Secondary

Living in the Doors - CAC

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

Time frame: within 10 days of CT scan

Population: The data is separated into two rows. Each row corresponds to a group. Participants were placed into one of the two groups based on certain criteria. Each group has a different number of participants analyzed. The total for both groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Living in the Doors - CAC> 5 years living in dormslow risk0 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC> 5 years living in dormslow - moderate risk7 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC> 5 years living in dormsmoderate - high risk1 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC> 5 years living in dormshigh risk2 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC> 5 years living in dormsvery high risk0 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC< 5 years living in dormslow risk0 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC< 5 years living in dormslow - moderate risk84 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC< 5 years living in dormsmoderate - high risk7 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC< 5 years living in dormshigh risk4 Participants
Coronary Artery Calcium (CAC)Living in the Doors - CAC< 5 years living in dormsvery high risk2 Participants
Comparison: CAC risk category (low, low-mod, moderate - high, high, and very high)p-value: 0.13Fisher Exact
Secondary

Living in the Dorms - Compare FRS to CAC

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

Time frame: within 10 days of CT scan

Population: The data is separated into two rows for each arm. Each row corresponds to a group. Participants were placed into one of the two groups based on certain criteria. Each group has a different number of participants analyzed. The total for both groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC> 5 years living in dormslow risk9 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC> 5 years living in dormslow - moderate / moderate risk0 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC> 5 years living in dormsmoderate - high risk1 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC> 5 years living in dormshigh risk0 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC> 5 years living in dormsvery high risk0 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC< 5 years living in dormslow risk90 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC< 5 years living in dormslow - moderate / moderate risk1 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC< 5 years living in dormsmoderate - high risk6 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC< 5 years living in dormshigh risk0 Participants
Coronary Artery Calcium (CAC)Living in the Dorms - Compare FRS to CAC< 5 years living in dormsvery high risk0 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC< 5 years living in dormsmoderate - high risk7 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC> 5 years living in dormslow risk0 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC< 5 years living in dormslow risk0 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC> 5 years living in dormslow - moderate / moderate risk7 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC< 5 years living in dormsvery high risk2 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC> 5 years living in dormsmoderate - high risk1 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC< 5 years living in dormslow - moderate / moderate risk84 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC> 5 years living in dormshigh risk2 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC< 5 years living in dormshigh risk4 Participants
CAC Risk CategoryLiving in the Dorms - Compare FRS to CAC> 5 years living in dormsvery high risk0 Participants
Comparison: FRS risk categories (low, moderate, mod -high, high, and very high)p-value: 0.56Fisher Exact
Comparison: CAC risk category (low, low-mod, moderate - high, high, and very high)p-value: 0.13Fisher Exact
Secondary

Metabolic Syndrome - CAC

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

Time frame: within 10 days of CT scan

Population: The data is separated into two rows. Each row corresponds to a group. Participants were placed into one of the two groups based on certain criteria. Each group has a different number of participants analyzed. The total for both groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACmetabolic syndromehigh risk1 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACmetabolic syndromevery high risk0 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACmetabolic syndromelow risk0 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACmetabolic syndromelow - moderate risk18 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACmetabolic syndromemoderate - high risk4 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACno metabolic syndromelow risk0 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACno metabolic syndromelow - moderate risk73 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACno metabolic syndromemoderate - high risk4 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACno metabolic syndromehigh risk5 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - CACno metabolic syndromevery high risk2 Participants
Comparison: CAC risk category (low, low-mod, mod-high, high, very high)p-value: 0.21Fisher Exact
Secondary

Metabolic Syndrome - Compare FRS to CAC

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

Time frame: within 10 days of CT scan

Population: The data is separated into two rows for each arm. Each row corresponds to a group. Participants were placed into one of the two groups based on certain criteria. Each group has a different number of participants analyzed. The total for both groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACmetabolic syndromevery high risk0 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACmetabolic syndromelow risk19 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACmetabolic syndromelow - moderate / moderate risk1 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACmetabolic syndromemoderate - high risk3 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACmetabolic syndromehigh risk0 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACno metabolic syndromelow risk80 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACno metabolic syndromelow - moderate / moderate risk0 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACno metabolic syndromemoderate - high risk4 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACno metabolic syndromehigh risk0 Participants
Coronary Artery Calcium (CAC)Metabolic Syndrome - Compare FRS to CACno metabolic syndromevery high risk0 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACno metabolic syndromemoderate - high risk4 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACno metabolic syndromelow risk0 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACmetabolic syndromelow risk0 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACno metabolic syndromevery high risk2 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACmetabolic syndromelow - moderate / moderate risk18 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACno metabolic syndromelow - moderate / moderate risk73 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACmetabolic syndromemoderate - high risk4 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACno metabolic syndromehigh risk5 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACmetabolic syndromehigh risk1 Participants
CAC Risk CategoryMetabolic Syndrome - Compare FRS to CACmetabolic syndromevery high risk0 Participants
Comparison: FRS risk category (low, mod, mod-high, high, very high risk)p-value: 0.063Fisher Exact
Comparison: CAC risk category (low, low-mod, mod-high, high, very high)p-value: 0.21Fisher Exact
Secondary

Physical Fitness (PT) Failures - Compare FRS to CAC

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

Time frame: within 10 days of CT scan

Population: 1 subject had no data. Data are separated into 2 rows (groups). Participants were placed into 1 of 2 groups based on certain criteria. Each group has a different number of participants. The total for both groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwith PT failurelow risk48 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwith PT failurelow - moderate / moderate risk0 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwith PT failuremoderate - high risk5 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwith PT failurehigh risk0 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwith PT failurevery high risk0 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwithout PT failurelow risk50 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwithout PT failurelow - moderate / moderate risk1 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwithout PT failuremoderate - high risk2 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwithout PT failurehigh risk0 Participants
Coronary Artery Calcium (CAC)Physical Fitness (PT) Failures - Compare FRS to CACwithout PT failurevery high risk0 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwithout PT failuremoderate - high risk5 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwith PT failurelow risk0 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwithout PT failurelow risk0 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwith PT failurelow - moderate / moderate risk46 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwithout PT failurevery high risk0 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwith PT failuremoderate - high risk3 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwithout PT failurelow - moderate / moderate risk44 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwith PT failurehigh risk2 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwithout PT failurehigh risk4 Participants
CAC Risk CategoryPhysical Fitness (PT) Failures - Compare FRS to CACwith PT failurevery high risk2 Participants
Comparison: FRS risk categories (low, moderate, moderate-high, high, and very high)p-value: 0.44Fisher Exact
Comparison: CAC risk categories (low, low-moderate, mod -high, high, and very high)p-value: 0.49Fisher Exact
Secondary

PT Failures - CAC

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

Time frame: within 10 days of CT scan

Population: 1 subject had no data. Data are separated into 2 rows (groups). Participants were placed into 1 of 2 groups based on certain criteria. Each group has a different number of participants. The total for both groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)PT Failures - CACwith PT failureslow risk0 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwith PT failureslow - moderate risk46 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwith PT failuresmoderate - high risk3 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwith PT failureshigh risk2 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwith PT failuresvery high risk2 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwithout PT failureslow risk0 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwithout PT failureslow - moderate risk44 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwithout PT failuresmoderate - high risk5 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwithout PT failureshigh risk4 Participants
Coronary Artery Calcium (CAC)PT Failures - CACwithout PT failuresvery high risk0 Participants
Comparison: CAC risk categories (low, low-moderate, mod -high, high, and very high)p-value: 0.49Fisher Exact
Secondary

Years of Military Service - CAC

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

Time frame: within 10 days of CT scan

Population: The data is separated into 4 rows. Each row corresponds to a group. Participants were placed into one of the 4 groups based on certain criteria. Each group has a different number of participants analyzed. The total for all groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Years of Military Service - CAC10-14 years of military servicelow risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC10-14 years of military servicelow - moderate risk7 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC10-14 years of military servicemoderate - high risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC10-14 years of military servicehigh risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC10-14 years of military servicevery high risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC15-19 years of military servicelow risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC15-19 years of military servicelow - moderate risk40 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC15-19 years of military servicemoderate - high risk1 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC15-19 years of military servicehigh risk3 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC15-19 years of military servicevery high risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC20-24 years of military servicelow risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC20-24 years of military servicelow - moderate risk35 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC20-24 years of military servicemoderate - high risk1 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC20-24 years of military servicehigh risk3 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC20-24 years of military servicevery high risk1 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC25 or more years of military servicelow risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC25 or more years of military servicelow - moderate risk9 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC25 or more years of military servicemoderate - high risk6 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC25 or more years of military servicehigh risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - CAC25 or more years of military servicevery high risk1 Participants
Comparison: CAC risk category (low, low-mod, mod-high, high, very high risk)p-value: 0.003Fisher Exact
Secondary

Years of Military Service - Compare FRS to CAC

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

Time frame: within 10 days of CT scan

Population: Unable to perform statistical test for 10-14 years of service due to small number of subjects (7). Data are separated into 4 rows (groups). Participants were placed into 1 of 4 groups based on certain criteria. Each group has a different number of participants. The total for all groups (rows) is equal to the overall number of participants analyzed

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC15-19 years of military servicevery high risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC20-24 years of military servicehigh risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC15-19 years of military servicelow - moderate / moderate risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC20-24 years of military servicevery high risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC20-24 years of military servicelow risk39 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC25 or more years of military servicelow risk14 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC15-19 years of military servicehigh risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC25 or more years of military servicelow - moderate / moderate risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC20-24 years of military servicelow - moderate / moderate risk1 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC25 or more years of military servicemoderate - high2 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC15-19 years of military servicemoderate - high4 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC25 or more years of military servicehigh risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC20-24 years of military servicemoderate - high0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC25 or more years of military servicevery high risk0 Participants
Coronary Artery Calcium (CAC)Years of Military Service - Compare FRS to CAC15-19 years of military servicelow risk40 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC25 or more years of military servicevery high risk1 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC15-19 years of military servicelow risk0 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC15-19 years of military servicelow - moderate / moderate risk40 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC15-19 years of military servicemoderate - high1 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC15-19 years of military servicehigh risk3 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC15-19 years of military servicevery high risk0 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC20-24 years of military servicelow risk0 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC20-24 years of military servicelow - moderate / moderate risk35 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC20-24 years of military servicemoderate - high1 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC20-24 years of military servicehigh risk3 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC20-24 years of military servicevery high risk1 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC25 or more years of military servicelow risk0 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC25 or more years of military servicelow - moderate / moderate risk9 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC25 or more years of military servicemoderate - high6 Participants
CAC Risk CategoryYears of Military Service - Compare FRS to CAC25 or more years of military servicehigh risk0 Participants
Comparison: FRS risk categories (low, moderate, moderate -high, high, and very high)p-value: 0.11Fisher Exact
Comparison: CAC risk category (low, low-mod, mod-high, high, very high risk)p-value: 0.003Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026