PET Stress Test vs CAC Scan for Coronary Artery Disease

(ACCURATE Trial)

Overseen By Patti Spencer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

Disqualifiers: Prior CAD, Heart transplant, Severe valve disease, Decompensated heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

2500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a cheaper test, the CAC scan (a heart scan that checks for calcium buildup), can effectively guide treatment for individuals with possible coronary artery disease, instead of immediately using an expensive PET stress test. The primary goal is to assess whether starting with the CAC scan can save money without compromising patient outcomes. The trial includes two groups: one undergoes the PET stress test (an imaging test that evaluates blood flow to the heart), while the other receives non-PET management based on their CAC scan results. Individuals who have experienced chest pain or similar symptoms and have a CAC score higher than 1 may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could make heart disease diagnosis more affordable and accessible.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the PET stress test is generally safe for patients. Studies have found that the regadenoson PET stress test, a common heart imaging method, is well-tolerated by most people, including those with certain heart conditions like aortic stenosis. Serious side effects during or after the test are uncommon.

Another source confirms that PET stress tests can safely help doctors understand blood flow to the heart. Patients should follow instructions carefully during the test to ensure optimal results and safety.

While any medical procedure carries some risks or mild side effects, serious problems are rare. Overall, evidence supports the PET stress test as a safe method for assessing heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different approaches to assessing coronary artery disease: the PET stress test and the CAC scan. Unlike other methods that may rely heavily on symptom presentation or invasive procedures, the PET stress test directly images the heart under stress to determine the presence of ischemia, providing a dynamic picture of heart function. On the other hand, the CAC scan is a non-invasive method that measures calcium deposits in coronary arteries, offering insight into plaque buildup and potential risk. By comparing these two techniques, researchers aim to determine which offers better guidance for patient management and outcomes.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

This trial will compare the effectiveness of cardiac PET stress tests with coronary artery calcium (CAC) scans for diagnosing coronary artery disease. Research has shown that cardiac PET stress tests accurately detect blocked arteries in the heart. Participants randomized to the cardiac PET stress test arm will receive care based on the PET scan results. Studies suggest that PET scans can identify areas of the heart with reduced blood flow, aiding doctors in finding blockages and making them a reliable method for diagnosing serious heart disease.

Participants in the CAC-only arm will receive non-PET driven medical management. CAC scans, which are simpler and cheaper, detect calcium in the arteries, often indicating atherosclerosis, a condition that can lead to heart issues. While CAC scans are effective for identifying risk, PET scans offer a more detailed view of blood flow in the heart. Both tests have their benefits, but PET scans provide more detailed information when examining heart function closely. ^{1 6 7 8 9}

Who Is on the Research Team?

Kirk U Knowlton, MD

Principal Investigator

Intermountain Medical Center

Jeffrey Anderson

Principal Investigator

Intermountain Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Management without stress-imaging Experimental Treatment 1 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 management Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Published Research Related to This Trial

In a study involving 32 subjects, regadenoson was found to produce similar imaging results to dipyridamole for (82)RbCl PET scans, indicating its effectiveness in assessing cardiac perfusion and function.

Both visual assessments and quantitative measurements showed high correlation between regadenoson and dipyridamole, suggesting that regadenoson can be a suitable alternative due to its fixed dosing and favorable side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regadenoson pharmacologic rubidium-82 PET: a comparison of quantitative perfusion and function to dipyridamole. Cullom, SJ., Case, JA., Courter, SA., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 200 patients undergoing single photon emission computed tomography (SPECT) for coronary artery disease, eliminating the rest study rarely changed the interpretation of normal stress images, suggesting that a single stress test could be sufficient for diagnosis.

The findings indicate that rest studies are primarily beneficial for patients with abnormal or unclear stress images, which could lead to cost savings in nuclear procedures within managed health care systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost-effective sestamibi protocol in the managed health care era. Milan, E., Giubbini, R., Gioia, G., et al.[2019]

In a study of 90 patients undergoing myocardial perfusion PET/CT, those stressed with regadenoson exhibited significantly lower motion scores compared to those stressed with adenosine, indicating better image quality and accuracy.

The type of motion observed was more likely to be non-returning in patients receiving adenosine, suggesting that the choice of pharmacological stressor can greatly influence patient motion and the resulting imaging outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pharmacological stress agent on patient motion during rubidium-82 myocardial perfusion PET/CT. Memmott, MJ., Tonge, CM., Saint, KJ., et al.[2019]

Regadenoson is becoming the preferred pharmacological stressor for noninvasive functional imaging in diagnosing coronary artery disease (CAD), as it effectively induces hypoperfusion in patients with flow-limiting coronary stenosis.

The article reviews regadenoson's pharmacological properties, stress protocols, and highlights its efficacy and safety, emphasizing the importance for clinicians to understand its use in CAD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regadenoson stress for myocardial perfusion imaging. Reyes, E.[2015]

Regadenoson, a selective A(2A) receptor agonist, significantly increased coronary blood flow in dogs with mild-to-moderate coronary stenosis, demonstrating its potential as an effective vasodilator during myocardial contrast echocardiography.

The study found that regadenoson did not cause any arrhythmias and allowed for the detection of perfusion defects for up to 10 minutes after administration, indicating its safety and efficacy in identifying significant coronary artery blockages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of coronary stenosis with myocardial contrast echocardiography using regadenoson, a selective adenosine A2A receptor agonist. Le, DE., Bragadeesh, T., Zhao, Y., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Regadenoson, a newer selective adenosine receptor agonist, is as effective as traditional vasodilators like adenosine for detecting ischemia in stress perfusion studies, while being better tolerated by patients.

With over 7 million stress perfusion studies performed annually in the U.S., the use of vasodilator testing, including regadenoson, is crucial for noninvasive risk stratification in managing coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current advances in vasodilator pharmacological stress perfusion imaging. Druz, RS.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of 82Rb PET territorial myocardial asynchrony to arterial stenosis. Van Tosh, A., Votaw, JR., David Cooke, C., et al.[2021]

The noninvasive pacemaker stress echocardiography (PASE) test was found to be safe and effective for diagnosing coronary artery disease (CAD) in a study of 46 patients with permanent pacemakers, showing a sensitivity of 70% and specificity of 90%.

PASE demonstrated improved diagnostic accuracy when considering abnormal wall motion at rest, achieving a sensitivity of 85% and specificity of 84%, making it a promising alternative to traditional stress tests for patients with CAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive pacemaker stress echocardiography for diagnosis of coronary artery disease: a multicenter study. Picano, E., Alaimo, A., Chubuchny, V., et al.[2019]

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