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

• Sponsor: David Grant U.S. Air Force Medical Center (U.S. Fed)
• Overall Status: Terminated
• CT.gov ID: NCT02009930
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Actual Duration (Months): 56.4
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Plaque, Atherosclerotic

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 112 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
• Actual Study Start Date: Nov 5, 2013
• Actual Primary Completion Date: Jul 18, 2018
• Actual Study Completion Date: Jul 18, 2018

Outcome Measures

Primary Outcome Measures

1. Prevalence of Atherosclerosis [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.

2. Rate of Reclassification [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

3. Compare FRS to the CAC - At Least One Additional Risk Factor [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

Secondary Outcome Measures

1. Metabolic Syndrome - Compare FRS to CAC [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

2. Living in the Dorms - Compare FRS to CAC [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

3. Physical Fitness (PT) Failures - Compare FRS to CAC [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

4. Years of Military Service - Compare FRS to CAC [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

5. Additional Cardiovascular Risk Factors - Compare FRS to CAC [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

6. Metabolic Syndrome - CAC [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

7. Living in the Doors - CAC [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

8. PT Failures - CAC [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

9. Years of Military Service - CAC [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

10. Additional Risk Factors - CAC [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	David Grant USAF Medical Center	Travis Air Force Base	California	United States	94535

Sponsors and Collaborators

• David Grant U.S. Air Force Medical Center

Investigators

• Principal Investigator: Elijah Burton, MD, David Grant USAF Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2017

More Information

Publications

None provided.

• Responsible Party: Elijah Burton, Radiology Resident, David Grant U.S. Air Force Medical Center
• ClinicalTrials.gov Identifier: NCT02009930
• Other Study ID Numbers: FDG20130024H
• First Posted: Dec 12, 2013
• Last Update Posted: Jun 9, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elijah Burton, Radiology Resident, David Grant U.S. Air Force Medical Center: Military Active Duty Enlisted; Atherosclerosis; Coronary Artery Calcium (CAC); Cardiovascular; CAC Score; Framingham Score; CT Scan
• Additional relevant MeSH terms: Atherosclerosis; Plaque, Atherosclerotic

Study Results

Participant Flow

Recruitment Details	5 withdrawn

Arm/Group Title	Coronary Artery Calcium (CAC) / Framingham Risk Score (FRS)
Arm/Group Description	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
Period Title: Overall Study
STARTED	112
COMPLETED	107
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Coronary Artery Calcium (CAC) / Framingham Risk Score (FRS)
Arm/Group Description	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
Overall Participants	107
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.78505 (5.037647)
Sex: Female, Male (Count of Participants)
Female	3 2.8%
Male	104 97.2%
Race and Ethnicity Not Collected (Count of Participants)
More than one cardiovascular risk factor (Count of Participants)
Count of Participants [Participants]	107 100%

Outcome Measures

1. Primary Outcome

Title	Prevalence of Atherosclerosis
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coronary Artery Calcium (CAC)
Arm/Group Description	Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
Measure Participants	107
Count of Participants [Participants]	16 15%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Wilson Method used
	Estimated Value	16
	Confidence Interval	(2-Sided) 95%; 9.4 to 22.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Rate of Reclassification
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coronary Artery Calcification (CAC)
Arm/Group Description	Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
Measure Participants	107
higher risk category	99 92.5%
lower risk category	5 4.7%
same risk category	3 2.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		Only descriptive statistics were calculated (frequency, percent). Inferential statistics were not necessary, nor appropriate

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FRS Risk Category	CAC Risk Category
Arm/Group Description	Compare FRS risk categories (low, moderate, moderate -high, high, and very high) between groups	Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
Measure Participants	107	107
at least 1 additional risk factor	56 52.3%	56 NaN
no additional risk factors	51 47.7%	51 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC), CAC Risk Category
	Comments	Compare risk categories (FRS and CAC)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments	Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor expressed as a p-value
	Method	Spearman's Rank Correlation Coefficient
	Comments	Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor. Spearman's rho = 0.04

4. Secondary Outcome

Title	Metabolic Syndrome - Compare FRS to CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FRS Risk Category	CAC Risk Category
Arm/Group Description	Compare FRS risk categories (low, moderate, moderate -high, high, and very high) between groups	Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
Measure Participants	107	107
low risk	19 17.8%	0 NaN
low - moderate / moderate risk	1 0.9%	18 NaN
moderate - high risk	3 2.8%	4 NaN
high risk	0 0%	1 NaN
very high risk	0 0%	0 NaN
low risk	80 74.8%	0 NaN
low - moderate / moderate risk	0 0%	73 NaN
moderate - high risk	4 3.7%	4 NaN
high risk	0 0%	5 NaN
very high risk	0 0%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	FRS risk category (low, mod, mod-high, high, very high risk)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.063
	Comments	Relationship between FRS and metabolic syndrome. FRS risk category (low, mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (FRS - each risk category, metabolic syndrome - presence/absence) expressed as a p-value

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAC Risk Category
	Comments	CAC risk category (low, low-mod, mod-high, high, very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments	Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value

5. Secondary Outcome

Title	Living in the Dorms - Compare FRS to CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FRS Risk Category	CAC Risk Category
Arm/Group Description	Compare FRS risk categories (low, moderate, moderate -high, high, and very high) between groups	Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
Measure Participants	107	107
low risk	9 8.4%	0 NaN
low - moderate / moderate risk	0 0%	7 NaN
moderate - high risk	1 0.9%	1 NaN
high risk	0 0%	2 NaN
very high risk	0 0%	0 NaN
low risk	90 84.1%	0 NaN
low - moderate / moderate risk	1 0.9%	84 NaN
moderate - high risk	6 5.6%	7 NaN
high risk	0 0%	4 NaN
very high risk	0 0%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	FRS risk categories (low, moderate, mod -high, high, and very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments	Relationship between FRS and living in the dorms. FRS risk category (low, mod, mod-high, high, very high risk) and living in the dorms (< 5 years, > 5 years)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (FRS - each risk category, living in the dorms - <5 years/> 5 years) expressed as a p-value

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAC Risk Category
	Comments	CAC risk category (low, low-mod, moderate - high, high, and very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments	Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (< 5 years, > 5 years)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, living in the dorms - <5 years/> 5 years) expressed as a p-value

6. Secondary Outcome

Title	Physical Fitness (PT) Failures - Compare FRS to CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FRS Risk Category	CAC Risk Category
Arm/Group Description	Compare FRS risk categories (low, moderate, moderate -high, high, and very high) between groups	Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
Measure Participants	106	106
low risk	48 44.9%	0 NaN
low - moderate / moderate risk	0 0%	46 NaN
moderate - high risk	5 4.7%	3 NaN
high risk	0 0%	2 NaN
very high risk	0 0%	2 NaN
low risk	50 46.7%	0 NaN
low - moderate / moderate risk	1 0.9%	44 NaN
moderate - high risk	2 1.9%	5 NaN
high risk	0 0%	4 NaN
very high risk	0 0%	0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	FRS risk categories (low, moderate, moderate-high, high, and very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments	Relationship between FRS and PT failures. FRS risk category (low, mod, mod-high, high, very high risk) and PT failures (with, without PT failure)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (FRS - each risk category, PT failure - with/without PT failure) expressed as a p-value

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAC Risk Category
	Comments	CAC risk categories (low, low-moderate, mod -high, high, and very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments	Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value

7. Secondary Outcome

Title	Years of Military Service - Compare FRS to CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FRS Risk Category	CAC Risk Category
Arm/Group Description	Compare FRS risk categories (low, moderate, moderate -high, high, and very high) among groups	Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) among groups
Measure Participants	100	100
low risk	40 37.4%	0 NaN
low - moderate / moderate risk	0 0%	40 NaN
moderate - high	4 3.7%	1 NaN
high risk	0 0%	3 NaN
very high risk	0 0%	0 NaN
low risk	39 36.4%	0 NaN
low - moderate / moderate risk	1 0.9%	35 NaN
moderate - high	0 0%	1 NaN
high risk	0 0%	3 NaN
very high risk	0 0%	1 NaN
low risk	14 13.1%	0 NaN
low - moderate / moderate risk	0 0%	9 NaN
moderate - high	2 1.9%	6 NaN
high risk	0 0%	0 NaN
very high risk	0 0%	1 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	FRS risk categories (low, moderate, moderate -high, high, and very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments	Relationship between FRS and overall years of service. FRS risk category (low, mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (FRS - each risk category, overall years of service) expressed as a p-value

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CAC Risk Category
	Comments	CAC risk category (low, low-mod, mod-high, high, very high risk)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value

8. Secondary Outcome

Title	Additional Cardiovascular Risk Factors - Compare FRS to CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	FRS Risk Category	CAC Risk Category
Arm/Group Description	Compare FRS risk categories (low, moderate, moderate -high, high, and very high) among groups	Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) among groups
Measure Participants	0	0

9. Secondary Outcome

Title	Metabolic Syndrome - CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Coronary Artery Calcification (CAC)
Arm/Group Description	Compare CAC risk categories (low, low-mod, mod-high, high and very high) between groups
Measure Participants	107
low risk	0 0%
low - moderate risk	18 16.8%
moderate - high risk	4 3.7%
high risk	1 0.9%
very high risk	0 0%
low risk	0 0%
low - moderate risk	73 68.2%
moderate - high risk	4 3.7%
high risk	5 4.7%
very high risk	2 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	CAC risk category (low, low-mod, mod-high, high, very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments	Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value

10. Secondary Outcome

Title	Living in the Doors - CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Coronary Artery Calcification (CAC)
Arm/Group Description	Compare CAC risk categories (low, low-mod, mod-high, high and very high) between groups
Measure Participants	107
low risk	0 0%
low - moderate risk	7 6.5%
moderate - high risk	1 0.9%
high risk	2 1.9%
very high risk	0 0%
low risk	0 0%
low - moderate risk	84 78.5%
moderate - high risk	7 6.5%
high risk	4 3.7%
very high risk	2 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	CAC risk category (low, low-mod, moderate - high, high, and very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments	Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (< 5 years, > 5 years)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, living in the dorms - <5 years/> 5 years) expressed as a p-value

11. Secondary Outcome

Title	PT Failures - CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Coronary Artery Calcification (CAC)
Arm/Group Description	Compare CAC risk categories (low, low-mod, mod-high, high and very high) between groups
Measure Participants	106
low risk	0 0%
low - moderate risk	46 43%
moderate - high risk	3 2.8%
high risk	2 1.9%
very high risk	2 1.9%
low risk	0 0%
low - moderate risk	44 41.1%
moderate - high risk	5 4.7%
high risk	4 3.7%
very high risk	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	CAC risk categories (low, low-moderate, mod -high, high, and very high)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments	Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value

12. Secondary Outcome

Title	Years of Military Service - CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Coronary Artery Calcification (CAC)
Arm/Group Description	Compare CAC risk categories (low, low-mod, mod-high, high and very high) among groups
Measure Participants	107
low risk	0 0%
low - moderate risk	7 6.5%
moderate - high risk	0 0%
high risk	0 0%
very high risk	0 0%
low risk	0 0%
low - moderate risk	40 37.4%
moderate - high risk	1 0.9%
high risk	3 2.8%
very high risk	0 0%
low risk	0 0%
low - moderate risk	35 32.7%
moderate - high risk	1 0.9%
high risk	3 2.8%
very high risk	1 0.9%
low risk	0 0%
low - moderate risk	9 8.4%
moderate - high risk	6 5.6%
high risk	0 0%
very high risk	1 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Coronary Artery Calcium (CAC)
	Comments	CAC risk category (low, low-mod, mod-high, high, very high risk)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)
	Method	Fisher Exact
	Comments	Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value

13. Secondary Outcome

Title	Additional Risk Factors - CAC
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Coronary Artery Calcification (CAC)
Arm/Group Description	Compare CAC risk categories (low, low-mod, mod-high, high and very high) among groups
Measure Participants	0

Adverse Events

Time Frame	through study completion, up to 10 days
Arm/Group Title	Compare CAC and FRS
Arm/Group Description	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
All Cause Mortality
	Compare CAC and FRS
	Affected / at Risk (%)	# Events
Total	0/104 (0%)
Serious Adverse Events
	Compare CAC and FRS
	Affected / at Risk (%)	# Events
Total	0/104 (0%)
Other (Not Including Serious) Adverse Events
	Compare CAC and FRS
	Affected / at Risk (%)	# Events
Total	0/104 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.