Coronary Artery DiseaseNCT02636062
Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score
An observational study of Coronary Artery Disease and Endothelial Dysfunction, run by San Antonio Military Medical Center.
Trial summary
This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC) score of 0 given prior CAC zero > 5 years previous. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Endothelial Dysfunction, Atherosclerosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (> 18 years old) with a prior CAC score of 0 > 5 years ago or more will be contacted to enroll and undergo repeat CAC scanning.
Who may be able to join
- Adults aged 18 years or older
- Coronary Artery Calcium scoring test graded as 0 Agatston units
Who cannot join
- Interval development of symptomatic coronary artery disease (defined as prior PCI, CABG, or myocardial infarction) in the time between initial CAC scan and current data review. (These patients will not be enrolled in the trial to undergo repeat CAC testing, but any major cardiovascular events (MACE) will be documented in order to report the 5 year MACE rates amongst CAC zero patients in our population.)
- Pregnant females
- Implantable cardiac pacemaker or defibrillator
- Prior cardiac surgery for valvular heart disease
- Patients with CAC scores ≥ 1
- Patients in atrial fibrillation at the time of CAC acquisition
About this study
This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC) score of 0 given prior CAC zero > 5 years previous. Ancillary testing of serum, whole blood, and endothelial dysfunction will be performed to investigate any detectable systemic processes that predict CAC development.
Read the detailed description
This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior CAC score of 0 given prior CAC zero > 5 years previous. Study personnel will abstract CAC and coronary computed tomography angiography (CCTA) results on or prior to 31 December 2010 in a single, high-volume military medical center. All patients with CAC scores of zero, irrespective of whether or not this zero CAC was calculated in the presence of a CCTA with non-calcified plaque, will be offered inclusion in the study cohort. Patients will be contacted via telephone and offered study participation. Patients who sign written informed consent will be interviewed to abstract current medical history, medications, exercise practices, and social history. Cardiovascular risk factors of interest will be hypertension, hyperlipidemia, diabetes mellitus, and family history. Patients will then undergo blood draw (complete metabolic panel, complete blood count, lipid panel, serum insulin, high-sensitivity C-reactive protein (CRP), hemoglobin A1c, and thyroid function testing) to screen for undergoing cardiovascular risk factors and to be used as potential risk markers. Additionally, whole blood and serum will be obtained for future investigation to determine new markers of coronary artery disease (CAD) progression and genetic polymorphisms that may predict CAD progression. Patients will also undergo EndoPat testing utilizing an EndoPAT 2000® (digital pulse amplitude tonometry) to assess for endothelial dysfunction. Finally, patients will undergo repeat coronary artery calcium scoring based on standard laboratory protocols based on heart rate and body mass index.
- Keywords
- Coronary disease, Coronary artery disease (CAD), Endothelial dysfunction, Coronary artery calcium (CAC)
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up CAC > 0 | All patients with CAC scores of zero > 5 years previous will be invited to enroll and undergo repeat CAC scanning. This group will include all patients that develop incident CAC. | |
| Follow-up CAC zero | All patients with CAC scores of zero > 5 years previous will be invited to enroll and undergo repeat CAC scanning. This group will include all patients who continue to have a CAC of zero. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with CAC > 0
Incident development of any CAC (CAC > 0) between initial scan > 5 years previous and re-scan
Measured: 5 years
Secondary outcomes (3)
Major adverse cardiovascular events
The incidence of major adverse cardiovascular events (defined as death from cardiac cause, myocardial infarction, revascularization of obstructive coronary artery disease, stroke, heart failure, and new onset of atrial fibrillation), in all subjects screened for the study between initial CAC scan demonstrating zero CAC and current study screening.
Measured: 5 years
Per vessel incident CAC
Individual CAC score for each major epicardial coronary vessel in patients with development of incident CAC > 0
Measured: 5 years
Number of patients on statin therapy with incident CAC > 0 compared with statin naïve patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJul 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: PI - lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Antonio Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dustin M. Thomas, San Antonio Military Medical Center
- Investigators
- Dustin M Thomas, MD, Principal investigator, San Antonio Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636062
- Sponsor's protocol ID
- C.2016.055
- Status last verified
- Apr 2018
- First submitted
- 10 Dec 2015
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score
- ClinicalTrials.gov ID
- NCT02636062
- Acronym / sponsor ID
- C.2016.055
- Keywords
- Coronary disease, Coronary artery disease (CAD), Endothelial dysfunction, Coronary artery calcium (CAC)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI - lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- San Antonio Military Medical CenterUS federal agency
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC) score of 0 given prior CAC zero > 5 years previous. Ancillary testing of serum, whole blood, and endothelial dysfunction will be performed to investigate any detectable systemic processes that predict CAC development.
Detailed description
This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior CAC score of 0 given prior CAC zero > 5 years previous. Study personnel will abstract CAC and coronary computed tomography angiography (CCTA) results on or prior to 31 December 2010 in a single, high-volume military medical center. All patients with CAC scores of zero, irrespective of whether or not this zero CAC was calculated in the presence of a CCTA with non-calcified plaque, will be offered inclusion in the study cohort. Patients will be contacted via telephone and offered study participation. Patients who sign written informed consent will be interviewed to abstract current medical history, medications, exercise practices, and social history. Cardiovascular risk factors of interest will be hypertension, hyperlipidemia, diabetes mellitus, and family history. Patients will then undergo blood draw (complete metabolic panel, complete blood count, lipid panel, serum insulin, high-sensitivity C-reactive protein (CRP), hemoglobin A1c, and thyroid function testing) to screen for undergoing cardiovascular risk factors and to be used as potential risk markers. Additionally, whole blood and serum will be obtained for future investigation to determine new markers of coronary artery disease (CAD) progression and genetic polymorphisms that may predict CAD progression. Patients will also undergo EndoPat testing utilizing an EndoPAT 2000® (digital pulse amplitude tonometry) to assess for endothelial dysfunction. Finally, patients will undergo repeat coronary artery calcium scoring based on standard laboratory protocols based on heart rate and body mass index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up CAC > 0 | – | –All patients with CAC scores of zero > 5 years previous will be invited to enroll and undergo repeat CAC scanning. This group will include all patients that develop incident CAC. |
| Follow-up CAC zero | – | –All patients with CAC scores of zero > 5 years previous will be invited to enroll and undergo repeat CAC scanning. This group will include all patients who continue to have a CAC of zero. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (> 18 years old) with a prior CAC score of 0 > 5 years ago or more will be contacted to enroll and undergo repeat CAC scanning.
Key inclusion criteria (2 listed)
- Adults aged 18 years or older
- Coronary Artery Calcium scoring test graded as 0 Agatston units
Key exclusion criteria (6 listed)
- Interval development of symptomatic coronary artery disease (defined as prior PCI, CABG, or myocardial infarction) in the time between initial CAC scan and current data review. (These patients will not be enrolled in the trial to undergo repeat CAC testing, but any major cardiovascular events (MACE) will be documented in order to report the 5 year MACE rates amongst CAC zero patients in our population.)
- Pregnant females
- Implantable cardiac pacemaker or defibrillator
- Prior cardiac surgery for valvular heart disease
- Patients with CAC scores ≥ 1
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
Number of patients with CAC > 0
Time frame: 5 years
Incident development of any CAC (CAC > 0) between initial scan > 5 years previous and re-scan
3 secondary outcomes
Major adverse cardiovascular events
Time frame: 5 years
Per vessel incident CAC
Time frame: 5 years
Number of patients on statin therapy with incident CAC > 0 compared with statin naïve patients
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Dustin M Thomas, MD principal investigator
San Antonio Military Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Endothelial Dysfunction, run by San Antonio Military Medical Center.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with CAC > 0 (time frame: 5 years). 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 18 Apr 2018.