NCT03972774: ACCURATE

Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach.

Terminated NA Last updated 14 April 2026

What this trial tests

NA trial testing PET Stress Test in Coronary Artery Disease in 48 participants. Terminated before completion.

Timeline

19 November 2019

Primary endpoint
7 September 2023

7 September 2023

Quick facts

Lead sponsor	Intermountain Health Care, Inc.
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	48
Start date	19 November 2019
Primary completion	7 September 2023
Estimated completion	7 September 2023
Sites	1 location across United States

Drugs / interventions tested

• PET Stress Test
• Non-PET Medical Management

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Intermountain Health Care, Inc. — full company profile →

Who can join

50 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Coronary artery calcium testing in low-intermediate risk symptomatic patients with suspected coronary artery disease: An effective gatekeeper to further testing?
   Mahmood T, Shapiro MD. · · 2020 · cited 13× · PMID 33048982 · DOI 10.1371/journal.pone.0240539
2. The power of zero calcium in 82-Rubidium PET irrespective of sex and age.
   Frey SM, Clerc OF, Honegger U, Amrein M, et al · · 2023 · cited 6× · PMID 36624363 · DOI 10.1007/s12350-022-03174-3
3. Evaluation of three diagnostic algorithms to reduce normal scan rates, radiation exposure and costs in patients with suspected chronic coronary syndrome referred for 82Rb-Positron Emission Tomography (⁸²Rb-PET).
   Frey SM, Huré G, Leibfarth JP, Thommen K, et al · · 2025 · cited 1× · PMID 39800434 · DOI 10.1136/openhrt-2024-003086