Coronary Artery DiseaseDecide CTANCT00862056
Detection of Subclinical Atherosclerosis in Asymptomatic Individuals
An observational study of Coronary Artery Disease, run by Piedmont Healthcare at 1 site in United States.
Trial summary
This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary… Read more about this study
- Who is it for?
- Ages 35 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac CT
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2013
- 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 35 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Coronary Artery Disease
Who may be able to join
- Males between ages 35-90 or females between ages 40-90
- No known coronary artery disease
- no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel)
- no prior myocardial infarction
- no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
- no prior non-ST-elevation myocardial infarction (CK-MB > 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
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- no prior coronary revascularization procedure
- Aymptomatic
- no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia
- Presence of a high-risk feature (at least one of the following four will quality)
- High FRS ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
- Diabetes Mellitus
- Premature CAD in a first-degree relative
- High Risk Lipid Profile (must meet one of the following laboratory criteria)
- LDL > 250 mg/dL
- HDL < 20 mg/dL
- Triglycerides > 1000 mg/dL
- LP(a) > 80 mg/dL
- Provide written informed consent and Authorization for Use/Disclosure of PHI
Who cannot join
- Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
- Creatinine 1.5 mg/dL or greater
- Irregular rhythm precluding cardiac CT examination
- Uncontrolled hypertension (SBP>210 mmHg or DBP>140 mmHg on treatment)
- Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
- Known Pregnancy
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- Unwilling or unable to consent
- Presence of any co-morbidity that makes life expectancy less than 24 months
- Unwilling or unable to complete follow-up
- Unwilling or unable to provide written informed consent and Authorization for Use/Disclosure of PHI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals With High Likelihood of Coronary Artery Disease With a Novel, Low-Radiation Volumetric Computed Tomography Approach
This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac CT
- Keywords
- asymptomatic, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTProcedure or surgery
All participants will undergo a coronary artery CT angiogram with contrast.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT | All participants will undergo a coronary artery CT angiogram Receives: Procedure: Cardiac CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2013
- Study completionJul 2013
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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Rinehart, MD, Principal investigator, Piedmont Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862056
- Sponsor's protocol ID
- PH08012
- Acronym
- Decide CTA
- Status last verified
- Nov 2017
- First submitted
- 12 Mar 2009
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals With High Likelihood of Coronary Artery Disease With a Novel, Low-Radiation Volumetric Computed Tomography Approach
- ClinicalTrials.gov ID
- NCT00862056
- Acronym / sponsor ID
- Decide CTA / PH08012
- Conditions
- Coronary Artery Disease
- Keywords
- asymptomatic, coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Mar 2009 (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 will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT | – | Procedure: Cardiac CTAll participants will undergo a coronary artery CT angiogram |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary Artery Disease
Key inclusion criteria (19 listed)
- Males between ages 35-90 or females between ages 40-90
- No known coronary artery disease
- Aymptomatic
- Presence of a high-risk feature (at least one of the following four will quality)
- Provide written informed consent and Authorization for Use/Disclosure of PHI
Key exclusion criteria (10 listed)
- Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
- Creatinine 1.5 mg/dL or greater
- Irregular rhythm precluding cardiac CT examination
- Uncontrolled hypertension (SBP>210 mmHg or DBP>140 mmHg on treatment)
- Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CTAll participants will undergo a coronary artery CT angiogram with contrast. | Procedure or surgery | Cardiac CT |
Primary outcome
The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.
Time frame: 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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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.
Sarah Rinehart, MD principal investigator
Piedmont Healthcare
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 Coronary Artery Disease, run by Piedmont Healthcare 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 19 inclusion and 10 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: finished, as of the sponsor's last update on 20 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD. (time frame: 6 months, 1 year). 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 20 Nov 2017.