2500 Participants Needed

PET Stress Test vs CAC Scan for Coronary Artery Disease

(ACCURATE Trial)

PS
Overseen ByPatti Spencer
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Intermountain Health Care, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the PET Stress Test for Coronary Artery Disease?

Research shows that regadenoson, a drug used in PET stress tests, is safe and can help guide treatment decisions in patients with heart conditions, like those undergoing valve replacement. Additionally, PET stress tests using regadenoson can effectively identify heart issues, which may help in managing coronary artery disease.12345

Is the PET Stress Test using regadenoson safe for humans?

Regadenoson, used in PET Stress Tests, is generally safe and well-tolerated by patients. It is a newer agent that is better tolerated than adenosine, another common stress agent, and is used to help diagnose coronary artery disease.45678

How does the PET Stress Test differ from other treatments for coronary artery disease?

The PET Stress Test uses pharmacological stress agents like regadenoson, which is a selective coronary vasodilator, to assess blood flow in the heart, making it a noninvasive and patient-friendly alternative to traditional exercise stress tests. This approach is unique because it can be used for patients who cannot perform physical exercise, and regadenoson is better tolerated compared to other agents like adenosine.567910

What is the purpose of this trial?

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.

Research Team

JL

Jeffrey Anderson

Principal Investigator

Intermountain Medical Center

KU

Kirk U Knowlton, MD

Principal Investigator

Intermountain Medical Center

Eligibility Criteria

This trial is for men and women over 50 who may have coronary artery disease, as suggested by chest pain or similar symptoms. They must understand and agree to the study's process. People with known heart conditions, a high calcium score from previous tests, or certain other health issues can't join.

Inclusion Criteria

Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
I am scheduled for a cardiac PET scan to check for heart-related chest pain.
I am 50 years old or older.
See 1 more

Exclusion Criteria

I am scheduled for a heart PET/CT scan before my major non-chest surgery.
Your calcium score from your most recent heart check is higher than 1.
Your doctor thinks you have less than a year to live.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation

Participants undergo Coronary Artery Calcium (CAC) scan to assess coronary atherosclerosis

1 week
1 visit (in-person)

Randomization and Treatment

Participants are randomized to either a cardiac PET stress test strategy or a non-PET-driven medical care strategy

Varies based on treatment arm

Follow-up

Participants are monitored for major adverse cardiac endpoints and cost-effectiveness

5 years
Annual reviews

Treatment Details

Interventions

  • Non-PET Medical Management
  • PET Stress Test
Trial Overview The study compares two approaches in patients suspected of having coronary artery disease: one group gets a PET stress test directly while the other follows a 'calcium-first' strategy which could lead to medical management without PET if their calcium levels are low.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Management without stress-imagingExperimental Treatment1 Intervention
Subjects randomized to the CAC-only arm will receive appropriate non-PET driven medical clinical management and follow-up.
Group II: Cardiac PET stress testing and test-dependent managementExperimental Treatment1 Intervention
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials
142
Recruited
1,965,000+

Findings from Research

Stress PET using regadenoson is safe for patients with severe aortic stenosis, with no major adverse events reported during the study of 50 patients.
The PET results effectively guided revascularization decisions, with 44% of patients undergoing revascularization targeting areas of the heart that were at risk, as identified by the PET scan.
Stress positron emission tomography is safe and can guide coronary revascularization in high-risk patients being considered for transcatheter aortic valve replacement.Cremer, PC., Khalaf, S., Lou, J., et al.[2021]
This study is the first multicenter, multivendor comparison of regadenoson-stress myocardial CT perfusion (CTP) with SPECT, involving approximately 25 sites and various CT scanner models, which aims to assess the effectiveness of CTP in detecting myocardial ischemia in patients with known or suspected coronary artery disease.
The primary goal is to determine if CTP can match or exceed the agreement rate of SPECT for detecting ischemia, with a non-inferiority threshold set to ensure that CTP is at least as effective as SPECT in identifying heart issues.
Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison.Cury, RC., Kitt, TM., Feaheny, K., et al.[2015]
In a study of 105 patients with suspected coronary artery disease (CAD), 82Rb PET/CT imaging effectively identified multi-vessel disease (MVD) with a high accuracy (ROC AUC of 83% for asynchrony scores).
The study also demonstrated that regional asynchrony measurements were crucial in detecting individual arteries with severe stenosis (≥70%), showing an ROC AUC of 81%, highlighting the importance of asynchrony in assessing CAD.
Relationship of 82Rb PET territorial myocardial asynchrony to arterial stenosis.Van Tosh, A., Votaw, JR., David Cooke, C., et al.[2021]

References

Stress positron emission tomography is safe and can guide coronary revascularization in high-risk patients being considered for transcatheter aortic valve replacement. [2021]
Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison. [2015]
Relationship of 82Rb PET territorial myocardial asynchrony to arterial stenosis. [2021]
Regadenoson pharmacologic rubidium-82 PET: a comparison of quantitative perfusion and function to dipyridamole. [2022]
Impact of pharmacological stress agent on patient motion during rubidium-82 myocardial perfusion PET/CT. [2019]
Regadenoson stress for myocardial perfusion imaging. [2015]
Current advances in vasodilator pharmacological stress perfusion imaging. [2017]
Detection of coronary stenosis with myocardial contrast echocardiography using regadenoson, a selective adenosine A2A receptor agonist. [2016]
A cost-effective sestamibi protocol in the managed health care era. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Noninvasive pacemaker stress echocardiography for diagnosis of coronary artery disease: a multicenter study. [2019]
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