Trial Outcomes & Findings for Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service (NCT NCT02009930)
NCT ID: NCT02009930
Last Updated: 2020-06-09
Results Overview
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.
TERMINATED
112 participants
within 10 days of CT scan
2020-06-09
Participant Flow
5 withdrawn
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
withdrawn
|
5
|
Baseline Characteristics
5 withdrawn
Baseline characteristics by cohort
| Measure |
Coronary Artery Calcium (CAC) / Framingham Risk Score (FRS)
n=107 Participants
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
|
|---|---|
|
Age, Continuous
|
40.78505 years
STANDARD_DEVIATION 5.037647 • n=107 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=107 Participants • 5 withdrawn
|
|
Sex: Female, Male
Male
|
104 Participants
n=107 Participants • 5 withdrawn
|
|
More than one cardiovascular risk factor
|
107 Participants
n=107 Participants • 5 withdrawn
|
PRIMARY outcome
Timeframe: within 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.
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Prevalence of Atherosclerosis
|
16 Participants
|
—
|
PRIMARY outcome
Timeframe: within 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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Rate of Reclassification
lower risk category
|
5 Participants
|
—
|
|
Rate of Reclassification
higher risk category
|
99 Participants
|
—
|
|
Rate of Reclassification
same risk category
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
n=107 Participants
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Compare FRS to the CAC - At Least One Additional Risk Factor
at least 1 additional risk factor
|
56 Participants
|
56 Participants
|
|
Compare FRS to the CAC - At Least One Additional Risk Factor
no additional risk factors
|
51 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
n=107 Participants
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Metabolic Syndrome - Compare FRS to CAC
metabolic syndrome · very high risk
|
0 Participants
|
0 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
no metabolic syndrome · low - moderate / moderate risk
|
0 Participants
|
73 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
no metabolic syndrome · moderate - high risk
|
4 Participants
|
4 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
no metabolic syndrome · high risk
|
0 Participants
|
5 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
no metabolic syndrome · very high risk
|
0 Participants
|
2 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
no metabolic syndrome · low risk
|
80 Participants
|
0 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
metabolic syndrome · low risk
|
19 Participants
|
0 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
metabolic syndrome · low - moderate / moderate risk
|
1 Participants
|
18 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
metabolic syndrome · moderate - high risk
|
3 Participants
|
4 Participants
|
|
Metabolic Syndrome - Compare FRS to CAC
metabolic syndrome · high risk
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
n=107 Participants
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Living in the Dorms - Compare FRS to CAC
> 5 years living in dorms · low risk
|
9 Participants
|
0 Participants
|
|
Living in the Dorms - Compare FRS to CAC
> 5 years living in dorms · low - moderate / moderate risk
|
0 Participants
|
7 Participants
|
|
Living in the Dorms - Compare FRS to CAC
> 5 years living in dorms · moderate - high risk
|
1 Participants
|
1 Participants
|
|
Living in the Dorms - Compare FRS to CAC
> 5 years living in dorms · high risk
|
0 Participants
|
2 Participants
|
|
Living in the Dorms - Compare FRS to CAC
> 5 years living in dorms · very high risk
|
0 Participants
|
0 Participants
|
|
Living in the Dorms - Compare FRS to CAC
< 5 years living in dorms · low risk
|
90 Participants
|
0 Participants
|
|
Living in the Dorms - Compare FRS to CAC
< 5 years living in dorms · low - moderate / moderate risk
|
1 Participants
|
84 Participants
|
|
Living in the Dorms - Compare FRS to CAC
< 5 years living in dorms · moderate - high risk
|
6 Participants
|
7 Participants
|
|
Living in the Dorms - Compare FRS to CAC
< 5 years living in dorms · high risk
|
0 Participants
|
4 Participants
|
|
Living in the Dorms - Compare FRS to CAC
< 5 years living in dorms · very high risk
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=106 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
n=106 Participants
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
with PT failure · low risk
|
48 Participants
|
0 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
with PT failure · low - moderate / moderate risk
|
0 Participants
|
46 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
with PT failure · moderate - high risk
|
5 Participants
|
3 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
with PT failure · high risk
|
0 Participants
|
2 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
with PT failure · very high risk
|
0 Participants
|
2 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
without PT failure · low risk
|
50 Participants
|
0 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
without PT failure · low - moderate / moderate risk
|
1 Participants
|
44 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
without PT failure · moderate - high risk
|
2 Participants
|
5 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
without PT failure · high risk
|
0 Participants
|
4 Participants
|
|
Physical Fitness (PT) Failures - Compare FRS to CAC
without PT failure · very high risk
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=100 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
n=100 Participants
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Years of Military Service - Compare FRS to CAC
15-19 years of military service · low risk
|
40 Participants
|
0 Participants
|
|
Years of Military Service - Compare FRS to CAC
15-19 years of military service · low - moderate / moderate risk
|
0 Participants
|
40 Participants
|
|
Years of Military Service - Compare FRS to CAC
15-19 years of military service · moderate - high
|
4 Participants
|
1 Participants
|
|
Years of Military Service - Compare FRS to CAC
15-19 years of military service · high risk
|
0 Participants
|
3 Participants
|
|
Years of Military Service - Compare FRS to CAC
15-19 years of military service · very high risk
|
0 Participants
|
0 Participants
|
|
Years of Military Service - Compare FRS to CAC
20-24 years of military service · low risk
|
39 Participants
|
0 Participants
|
|
Years of Military Service - Compare FRS to CAC
20-24 years of military service · low - moderate / moderate risk
|
1 Participants
|
35 Participants
|
|
Years of Military Service - Compare FRS to CAC
20-24 years of military service · moderate - high
|
0 Participants
|
1 Participants
|
|
Years of Military Service - Compare FRS to CAC
20-24 years of military service · high risk
|
0 Participants
|
3 Participants
|
|
Years of Military Service - Compare FRS to CAC
20-24 years of military service · very high risk
|
0 Participants
|
1 Participants
|
|
Years of Military Service - Compare FRS to CAC
25 or more years of military service · low risk
|
14 Participants
|
0 Participants
|
|
Years of Military Service - Compare FRS to CAC
25 or more years of military service · low - moderate / moderate risk
|
0 Participants
|
9 Participants
|
|
Years of Military Service - Compare FRS to CAC
25 or more years of military service · moderate - high
|
2 Participants
|
6 Participants
|
|
Years of Military Service - Compare FRS to CAC
25 or more years of military service · high risk
|
0 Participants
|
0 Participants
|
|
Years of Military Service - Compare FRS to CAC
25 or more years of military service · very high risk
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Metabolic Syndrome - CAC
metabolic syndrome · low risk
|
0 Participants
|
—
|
|
Metabolic Syndrome - CAC
metabolic syndrome · low - moderate risk
|
18 Participants
|
—
|
|
Metabolic Syndrome - CAC
metabolic syndrome · moderate - high risk
|
4 Participants
|
—
|
|
Metabolic Syndrome - CAC
metabolic syndrome · high risk
|
1 Participants
|
—
|
|
Metabolic Syndrome - CAC
metabolic syndrome · very high risk
|
0 Participants
|
—
|
|
Metabolic Syndrome - CAC
no metabolic syndrome · low risk
|
0 Participants
|
—
|
|
Metabolic Syndrome - CAC
no metabolic syndrome · low - moderate risk
|
73 Participants
|
—
|
|
Metabolic Syndrome - CAC
no metabolic syndrome · moderate - high risk
|
4 Participants
|
—
|
|
Metabolic Syndrome - CAC
no metabolic syndrome · high risk
|
5 Participants
|
—
|
|
Metabolic Syndrome - CAC
no metabolic syndrome · very high risk
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Living in the Doors - CAC
> 5 years living in dorms · low risk
|
0 Participants
|
—
|
|
Living in the Doors - CAC
> 5 years living in dorms · low - moderate risk
|
7 Participants
|
—
|
|
Living in the Doors - CAC
> 5 years living in dorms · moderate - high risk
|
1 Participants
|
—
|
|
Living in the Doors - CAC
> 5 years living in dorms · high risk
|
2 Participants
|
—
|
|
Living in the Doors - CAC
> 5 years living in dorms · very high risk
|
0 Participants
|
—
|
|
Living in the Doors - CAC
< 5 years living in dorms · low risk
|
0 Participants
|
—
|
|
Living in the Doors - CAC
< 5 years living in dorms · low - moderate risk
|
84 Participants
|
—
|
|
Living in the Doors - CAC
< 5 years living in dorms · moderate - high risk
|
7 Participants
|
—
|
|
Living in the Doors - CAC
< 5 years living in dorms · high risk
|
4 Participants
|
—
|
|
Living in the Doors - CAC
< 5 years living in dorms · very high risk
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=106 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
PT Failures - CAC
with PT failures · low risk
|
0 Participants
|
—
|
|
PT Failures - CAC
with PT failures · low - moderate risk
|
46 Participants
|
—
|
|
PT Failures - CAC
with PT failures · moderate - high risk
|
3 Participants
|
—
|
|
PT Failures - CAC
with PT failures · high risk
|
2 Participants
|
—
|
|
PT Failures - CAC
with PT failures · very high risk
|
2 Participants
|
—
|
|
PT Failures - CAC
without PT failures · low risk
|
0 Participants
|
—
|
|
PT Failures - CAC
without PT failures · low - moderate risk
|
44 Participants
|
—
|
|
PT Failures - CAC
without PT failures · moderate - high risk
|
5 Participants
|
—
|
|
PT Failures - CAC
without PT failures · high risk
|
4 Participants
|
—
|
|
PT Failures - CAC
without PT failures · very high risk
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
| Measure |
Coronary Artery Calcium (CAC)
n=107 Participants
Compare CAC risk categories (low, low-mod, mod-high and very high) between groups
|
CAC Risk Category
Compare CAC risk categories (low, low - moderate, moderate -high, high, and very high) between groups
|
|---|---|---|
|
Years of Military Service - CAC
10-14 years of military service · low risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
10-14 years of military service · low - moderate risk
|
7 Participants
|
—
|
|
Years of Military Service - CAC
10-14 years of military service · moderate - high risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
10-14 years of military service · high risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
10-14 years of military service · very high risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
15-19 years of military service · low risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
15-19 years of military service · low - moderate risk
|
40 Participants
|
—
|
|
Years of Military Service - CAC
15-19 years of military service · moderate - high risk
|
1 Participants
|
—
|
|
Years of Military Service - CAC
15-19 years of military service · high risk
|
3 Participants
|
—
|
|
Years of Military Service - CAC
15-19 years of military service · very high risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
20-24 years of military service · low risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
20-24 years of military service · low - moderate risk
|
35 Participants
|
—
|
|
Years of Military Service - CAC
20-24 years of military service · moderate - high risk
|
1 Participants
|
—
|
|
Years of Military Service - CAC
20-24 years of military service · high risk
|
3 Participants
|
—
|
|
Years of Military Service - CAC
20-24 years of military service · very high risk
|
1 Participants
|
—
|
|
Years of Military Service - CAC
25 or more years of military service · low risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
25 or more years of military service · low - moderate risk
|
9 Participants
|
—
|
|
Years of Military Service - CAC
25 or more years of military service · moderate - high risk
|
6 Participants
|
—
|
|
Years of Military Service - CAC
25 or more years of military service · high risk
|
0 Participants
|
—
|
|
Years of Military Service - CAC
25 or more years of military service · very high risk
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: within 10 days of CT scanPopulation: 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
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
Outcome measures
Outcome data not reported
Adverse Events
Compare CAC and FRS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elijah Burton
David Grant Medical Center, Travis Air Force Base
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place