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Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach.
NCT03972774 · View on ClinicalTrials.gov ↗
Study 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). 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
Conditions Studied
Interventions
- DIAGNOSTIC_TEST PET Stress Test
- OTHER Non-PET Medical Management
Study Locations (1)
Utah
- Intermountain Healthcare Hospitals and Clinics — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2029-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03972774
The ClinicalTrials.gov registry entry for NCT03972774 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intermountain Health Care, which has 58 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which PET Stress Test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03972774 reports 1 study location spanning 1 distinct geographic area — top geographies include Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03972774 about?
NCT03972774 is a clinical study titled "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 p...
What is the current status of trial NCT03972774?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,500 participants. The study started on 2019-11-19. Estimated completion is 2029-11.
What conditions does trial NCT03972774 study?
This clinical trial studies the following conditions: Coronary Artery Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03972774?
The interventions under investigation include: PET Stress Test (DIAGNOSTIC_TEST), Non-PET Medical Management (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03972774?
This trial is sponsored by Intermountain Health Care, which has 58 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03972774 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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