AtherosclerosisNCT02009930
Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
An observational study of Atherosclerosis and Plaque, Atherosclerotic, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Plaque, Atherosclerotic
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2013to 18 Jul 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Active duty military enlisted members with 10 or more years of service
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant USAF Medical Center
Travis Air Force Base, California, 94535
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis, Plaque, Atherosclerotic
- Keywords
- Military Active Duty Enlisted, Atherosclerosis, Coronary Artery Calcium (CAC), Cardiovascular, CAC Score, Framingham Score, CT Scan
- Medical subject headings
- Atherosclerosis, Plaque, Atherosclerotic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 10 days of CT scan
Rate of Reclassification
Percent/Number of subject that were reclassified from FRS to CAC risk category using CAC scores. The CAC risk category (scale) = CAC score (estimated degree of calcium in coronary arteries, a number) + percentage by age to establish risks of future CV events. There are 5 risk categories: low, low - moderate, moderate - high, very high. The Framingham risk category (scale) = FRS to estimate the risk of a CV event over the next 10 years. The FRS uses age, systolic blood pressure, high-density lipoprotein (HDL) cholesterol level, total cholesterol level, and smoking status to create a score that is converted into a 10-year CV disease risk % that correlates into a risk category: low, moderate, moderate - high risk, very high. For both scales, low is the best and very high is the worst outcome
Measured: within 10 days of CT scan
Compare FRS to the CAC - At Least One Additional Risk Factor
Compare FRS risk category to CAC risk category for enlisted subjects with at least 10 years of service and at least one additional CV risk factor to determine how well the results correlate with one another using the Spearman's Rank Correlation Coefficient. The CAC risk category (scale) = CAC score (estimated degree of calcium in coronary arteries, a number) + percentage by age to establish risks of future CV events. There are 5 risk categories: low, low - moderate, moderate - high, very high. The Framingham risk category (scale) = FRS to estimate the risk of a CV event over the next 10 years. The FRS uses age, systolic blood pressure, high-density lipoprotein (HDL) cholesterol level, total cholesterol level, and smoking status to create a score that is converted into a 10-year CV disease risk % that correlates into a risk category: low, moderate, moderate - high risk, very high. For both scales, low is the best and very high is the worst outcome
Measured: within 10 days of CT scan
Secondary outcomes (10)
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
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
Measured: within 10 days of CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study start5 Nov 2013
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Why it stopped: Failure to recruit enough subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Elijah Burton, David Grant U.S. Air Force Medical Center
- Investigators
- Elijah Burton, MD, Principal investigator, David Grant USAF Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009930
- Sponsor's protocol ID
- FDG20130024H
- Status last verified
- May 2020
- First submitted
- 9 Dec 2013
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Artery Calcium in Active Duty Enlisted Military Members With 10 or More Years of Service
- ClinicalTrials.gov ID
- NCT02009930
- Acronym / sponsor ID
- FDG20130024H
- Conditions
- Atherosclerosis, Plaque, Atherosclerotic
- Keywords
- Military Active Duty Enlisted, Atherosclerosis, Coronary Artery Calcium (CAC), Cardiovascular, CAC Score, Framingham Score, CT Scan
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Failure to recruit enough subjects
- Enrolment
- 112 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Active duty military enlisted members with 10 or more years of service
Key inclusion criteria (9 listed)
- 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)
- 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)
Key exclusion criteria (18 listed)
- 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.
- Coronary Artery Disease (CAD)
- Coronary Artery Bypass Grafting (CABG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Atherosclerosis
Time frame: within 10 days of CT scan
Percent of active duty enlisted military members with 10 or more years of military service determined to have a prevalence of atherosclerosis based on CAC risk category. The CAC risk category (scale), is derived from the CAC score (i.e., an estimate of the degree of atherosclerosis present in each participant's coronary arteries, reported as a number), and percentage by age to establish risk of future CV events. There are 5 risk categories: Low risk = CAC of 0 and no cardiovascular (CV) risk factors, Low - Moderate risk = CAC of 0 with CV risk factors, Moderate - High risk: CAC 1-100 and percentile for age <75%, High risk = CAC 100-399 or percentile for age >75%, Very high risk = CAC >100 and percentile for age >90% or CAC >400". Low risk is the best outcome, and very high risk is the worst.
Rate of Reclassification
Time frame: within 10 days of CT scan
Percent/Number of subject that were reclassified from FRS to CAC risk category using CAC scores. The CAC risk category (scale) = CAC score (estimated degree of calcium in coronary arteries, a number) + percentage by age to establish risks of future CV events. There are 5 risk categories: low, low - moderate, moderate - high, very high. The Framingham risk category (scale) = FRS to estimate the risk of a CV event over the next 10 years. The FRS uses age, systolic blood pressure, high-density lipoprotein (HDL) cholesterol level, total cholesterol level, and smoking status to create a score that is converted into a 10-year CV disease risk % that correlates into a risk category: low, moderate, moderate - high risk, very high. For both scales, low is the best and very high is the worst outcome
Compare FRS to the CAC - At Least One Additional Risk Factor
Time frame: within 10 days of CT scan
Compare FRS risk category to CAC risk category for enlisted subjects with at least 10 years of service and at least one additional CV risk factor to determine how well the results correlate with one another using the Spearman's Rank Correlation Coefficient. The CAC risk category (scale) = CAC score (estimated degree of calcium in coronary arteries, a number) + percentage by age to establish risks of future CV events. There are 5 risk categories: low, low - moderate, moderate - high, very high. The Framingham risk category (scale) = FRS to estimate the risk of a CV event over the next 10 years. The FRS uses age, systolic blood pressure, high-density lipoprotein (HDL) cholesterol level, total cholesterol level, and smoking status to create a score that is converted into a 10-year CV disease risk % that correlates into a risk category: low, moderate, moderate - high risk, very high. For both scales, low is the best and very high is the worst outcome
10 secondary outcomes
Metabolic Syndrome - Compare FRS to CAC
Time frame: within 10 days of CT scan
Living in the Dorms - Compare FRS to CAC
Time frame: within 10 days of CT scan
Physical Fitness (PT) Failures - Compare FRS to CAC
Time frame: within 10 days of CT scan
Years of Military Service - Compare FRS to CAC
Time frame: within 10 days of CT scan
Additional Cardiovascular Risk Factors - Compare FRS to CAC
Time frame: within 10 days of CT scan
Metabolic Syndrome - CAC
Time frame: within 10 days of CT scan
Living in the Doors - CAC
Time frame: within 10 days of CT scan
PT Failures - CAC
Time frame: within 10 days of CT scan
Years of Military Service - CAC
Time frame: within 10 days of CT scan
Additional Risk Factors - CAC
Time frame: within 10 days of CT scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elijah Burton, MD principal investigator
David Grant USAF Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Plaque, Atherosclerotic, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Atherosclerosis (time frame: within 10 days of CT scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.