Coronary Artery DiseaseACCURATENCT03972774
Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach.
A study testing PET Stress Test and Non-PET Medical Management in people with Coronary Artery Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
The cost of medical care in the United States far exceeds that of all other advanced economies and continues to accelerate at a rate unacceptable to our society, due primarily to the high costs of new imaging technologies and novel drugs (1). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PET Stress Test and Non-PET Medical Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 7 Sep 2023
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥50 years old (i.e., to be of sufficiently high pre-test coronary risk)
- Cardiac PET regadenoson stress perfusion test has been ordered to assess a possible ischemic etiology of low/intermediate risk chest pain or equivalent symptoms (e.g., exertional dyspnea).
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
- CAC score of ≥1 per routine CAC first strategy (described above)
Who cannot join
- Disease history: If available for any of the following diseases: prior known CAD, heart transplant, LVAD, untreated severe valve disease (i.e., severe mitral stenosis, severe mitral regurgitation, and/or severe aortic stenosis), or decompensated heart failure (DHF).
- Those with a prior CAC score >1.
- CAC ≤1 prior to this current episode of cardiac assessment
- Who ELECT to not receive an updated CAC evaluation OR their referring clinician specifically prefers cardiac PET.
- CAC evaluation repeated at this current episode of cardiac assessment and is now >1.
- Evidence of possible acute coronary syndrome based on an elevated troponin I ≥0.04ng/mL and/or acute ECG changes of ischemia.
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- Life expectancy <1 year, as assessed by the investigator(s)
- Cardiac PET/CT is ordered in the pre-operative risk assessment in higher risk non-thoracic surgery.
- Cardiac PET/CT is ordered for assessment of underlying ischemia in those with arrhythmia to guide anti-arrhythmic therapy.
- Other conditions that in the opinion of the study investigators and/or referring clinician may increase risk to the subject and/or compromise the quality of the clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Healthcare Hospitals and Clinics
Salt Lake City, Utah, 84107
About this study
Official title: Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach
The cost of medical care in the United States far exceeds that of all other advanced economies and continues to accelerate at a rate unacceptable to our society, due primarily to the high costs of new imaging technologies and novel drugs (1). Cardiac positron emission tomography (PET) imaging is a powerful new modality for the non-invasive detection of provocable coronary ischemia in patients with low to intermediate-risk chest pain or its equivalent. Intermountain Medical Center (IMC) is performing approximately 6000 clinical cardiac PET scans annually. However, cardiac PET scans are expensive (i.e., billed at >$5,000/scan, average receivable revenue $1500-$2000/scan). Coronary artery calcium (CAC) is a sensitive marker of coronary atherosclerosis. A CAC scan (CACS), performed by multislice computed tomography (CT), is a relatively inexpensive (~$70-$150/scan), low-radiation dose test that marks the presence of coronary atherosclerotic plaque. The absence of CAC has been shown to be associated with very low coronary risk. ACCURATE will test whether a CAC-first strategy (i.e., risk stratification, when CAC ≤ 1, to medical management or to cardiac PET stress testing), performed routinely in symptomatic patients presenting for evaluation of possible coronary artery disease (CAD) prior to the cardiac PET stress test, can be used as a gatekeeper for progression to the expensive rubidium-PET stress (regadenoson) perfusion scan and be a major cost-saver without adversely affecting patient care or outcomes. Routinely, qualifying patients undergo CACS when they present for evaluation of possible but unknown CAD status and are referred for cardiac PET stress testing. In ACCURATE, those with CACS≤1 will then be consented and randomized to either a cardiac PET stress test strategy or a non-PET-driven medical care strategy. Subjects randomized to the cardiac PET stress test strategy will receive appropriate subsequent care depending on the outcome of the cardiac PET scan (i.e., depending on whether ischemia is present or not). Subjects randomized to the CAC-only arm will receive appropriate non-PET driven medical clinical management and follow-up. All participating subjects' electronic medical records will be reviewed indefinitely for clinical outcomes. Initial outcomes will be reported at 1-year, 2-years, and 5-years, with future analyses to be determined by the study investigators.
The objective of this study is to test the hypothesis that PET stress test strategy will results in a decreasing in major adverse cardiac endpoint without exceeding $100,000 per quality-adjusted life year compared to a CAC-first strategy for screening suspected/possible coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- PET Stress Test, Non-PET Medical Management
- 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.
PET Stress TestDiagnostic test
Cardiac positron emission tomography (PET)/computed tomography (CT) and test-result dependent management
Non-PET Medical ManagementOther
Appropriate medical management without cardiac PET stress-imaging
| Study group | Role | What they receive |
|---|---|---|
| Cardiac PET stress testing and test-dependent management | Other | Subjects randomized to the cardiac PET stress test strategy will receive appropriate subsequent care depending on the outcome of the cardiac PET scan (i.e., depending on whether ischemia is present or not). Receives: Diagnostic Test: PET Stress Test |
| Management without stress-imaging | Other | Subjects randomized to the CAC-only arm will receive appropriate non-PET driven medical clinical management and follow-up. Receives: Other: Non-PET Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferior major adverse cardiac endpoint (MACE) outcomes
Routine cardiac PET stress test strategy will result in significantly fewer major adverse cardiac endpoint (MACE) outcomes (defined as coronary death, non-fatal myocardial infarction, cardiac arrest, or ischemia driven revascularization) at 1 year compared with a a CAC-first strategy.
Measured: 1 year
Cost-effectiveness
The costs of routine cardiac PET stress test strategy will be less than <$100,000 per quality-adjusted life year (QALY) compared to CAC-first strategy. Cost-effectiveness, categorized by the American Heart Association, will be defined as achieving at least fair cost effectiveness, i.e., as achieving <$100,000/QALY, which is widely accepted as a "willingness-to-pay" threshold, with <$50,000/QALY defined as good cost-effectiveness.
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 posted4 Jun 2019
- Study start19 Nov 2019
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Why it stopped: The study was discontinued due to shift in imaging strategies for acute chest pain that mde it difficult and nearly impossible to recruit patients of interest.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirk U Knowlton, MD, Principal investigator, Intermountain Health Care, Inc.Jeffrey L Anderson, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972774
- Sponsor's protocol ID
- 1051080
- Acronym
- ACCURATE
- Status last verified
- Apr 2026
- First submitted
- 31 May 2019
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach
- ClinicalTrials.gov ID
- NCT03972774
- Acronym / sponsor ID
- ACCURATE / 1051080
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to shift in imaging strategies for acute chest pain that mde it difficult and nearly impossible to recruit patients of interest.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 4 Jun 2019 (actual)
- 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.
The cost of medical care in the United States far exceeds that of all other advanced economies and continues to accelerate at a rate unacceptable to our society, due primarily to the high costs of new imaging technologies and novel drugs (1). Cardiac positron emission tomography (PET) imaging is a powerful new modality for the non-invasive detection of provocable coronary ischemia in patients with low to intermediate-risk chest pain or its equivalent. Intermountain Medical Center (IMC) is performing approximately 6000 clinical cardiac PET scans annually. However, cardiac PET scans are expensive (i.e., billed at >$5,000/scan, average receivable revenue $1500-$2000/scan). Coronary artery calcium (CAC) is a sensitive marker of coronary atherosclerosis. A CAC scan (CACS), performed by multislice computed tomography (CT), is a relatively inexpensive (~$70-$150/scan), low-radiation dose test that marks the presence of coronary atherosclerotic plaque. The absence of CAC has been shown to be associated with very low coronary risk. ACCURATE will test whether a CAC-first strategy (i.e., risk stratification, when CAC ≤ 1, to medical management or to cardiac PET stress testing), performed routinely in symptomatic patients presenting for evaluation of possible coronary artery disease (CAD) prior to the cardiac PET stress test, can be used as a gatekeeper for progression to the expensive rubidium-PET stress (regadenoson) perfusion scan and be a major cost-saver without adversely affecting patient care or outcomes. Routinely, qualifying patients undergo CACS when they present for evaluation of possible but unknown CAD status and are referred for cardiac PET stress testing. In ACCURATE, those with CACS≤1 will then be consented and randomized to either a cardiac PET stress test strategy or a non-PET-driven medical care strategy. Subjects randomized to the cardiac PET stress test strategy will receive appropriate subsequent care depending on the outcome of the cardiac PET scan (i.e., depending on whether ischemia is present or not). Subjects randomized to the CAC-only arm will receive appropriate non-PET driven medical clinical management and follow-up. All participating subjects' electronic medical records will be reviewed indefinitely for clinical outcomes. Initial outcomes will be reported at 1-year, 2-years, and 5-years, with future analyses to be determined by the study investigators.
The objective of this study is to test the hypothesis that PET stress test strategy will results in a decreasing in major adverse cardiac endpoint without exceeding $100,000 per quality-adjusted life year compared to a CAC-first strategy for screening suspected/possible coronary artery disease.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac PET stress testing and test-dependent management | Other | Diagnostic Test: PET Stress TestSubjects randomized to the cardiac PET stress test strategy will receive appropriate subsequent care depending on the outcome of the cardiac PET scan (i.e., depending on whether ischemia is present or not). |
| Management without stress-imaging | Other | Other: Non-PET Medical ManagementSubjects randomized to the CAC-only arm will receive appropriate non-PET driven medical clinical management and follow-up. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females ≥50 years old (i.e., to be of sufficiently high pre-test coronary risk)
- Cardiac PET regadenoson stress perfusion test has been ordered to assess a possible ischemic etiology of low/intermediate risk chest pain or equivalent symptoms (e.g., exertional dyspnea).
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
- CAC score of ≥1 per routine CAC first strategy (described above)
Key exclusion criteria (10 listed)
- Disease history: If available for any of the following diseases: prior known CAD, heart transplant, LVAD, untreated severe valve disease (i.e., severe mitral stenosis, severe mitral regurgitation, and/or severe aortic stenosis), or decompensated heart failure (DHF).
- Those with a prior CAC score >1.
- CAC ≤1 prior to this current episode of cardiac assessment
- Evidence of possible acute coronary syndrome based on an elevated troponin I ≥0.04ng/mL and/or acute ECG changes of ischemia.
- Life expectancy <1 year, as assessed by the investigator(s)
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 |
|---|---|---|
| PET Stress TestCardiac positron emission tomography (PET)/computed tomography (CT) and test-result dependent management | Diagnostic test | Cardiac PET stress testing and test-dependent management |
| Non-PET Medical ManagementAppropriate medical management without cardiac PET stress-imaging | Other | Management without stress-imaging |
Primary outcome
Non-inferior major adverse cardiac endpoint (MACE) outcomes
Time frame: 1 year
Routine cardiac PET stress test strategy will result in significantly fewer major adverse cardiac endpoint (MACE) outcomes (defined as coronary death, non-fatal myocardial infarction, cardiac arrest, or ischemia driven revascularization) at 1 year compared with a a CAC-first strategy.
Cost-effectiveness
Time frame: 5 years
The costs of routine cardiac PET stress test strategy will be less than <$100,000 per quality-adjusted life year (QALY) compared to CAC-first strategy. Cost-effectiveness, categorized by the American Heart Association, will be defined as achieving at least fair cost effectiveness, i.e., as achieving <$100,000/QALY, which is widely accepted as a "willingness-to-pay" threshold, with <$50,000/QALY defined as good cost-effectiveness.
Results and safety
The study was stopped early (reason given: The study was discontinued due to shift in imaging strategies for acute chest pain that mde it difficult and nearly impossible to recruit patients of interest.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kirk U Knowlton, MD principal investigator
Intermountain Health Care, Inc.
Jeffrey L Anderson, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET Stress Test and Non-PET Medical Management in people with Coronary Artery Disease, run by Intermountain Health Care, Inc. 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 4 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: stopped early, as of the sponsor's last update on 14 Apr 2026. 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 was stopped early (reason given: The study was discontinued due to shift in imaging strategies for acute chest pain that mde it difficult and nearly impossible to recruit patients of interest.). Results are not available in the source record.
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?
Non-inferior major adverse cardiac endpoint (MACE) outcomes (time frame: 1 year). The study lists 2 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 14 Apr 2026.