PET Stress Test vs CAC Scan for Coronary Artery Disease
(ACCURATE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Intermountain Health Care, Inc.
Disqualifiers: Prior CAD, Heart transplant, Severe valve disease, Decompensated heart failure, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
45678How 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.
567910Eligibility 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.
+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.
+7 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Intermountain Healthcare Hospitals and ClinicsSalt Lake City, UT
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Who Is Running the Clinical Trial?
Intermountain Health Care, Inc.Lead Sponsor
References
Stress positron emission tomography is safe and can guide coronary revascularization in high-risk patients being considered for transcatheter aortic valve replacement. [2021]The safety and accuracy of regadenoson stress positron emission tomography (PET) in patients with significant aortic stenosis (AS) is unknown. In patients undergoing surgical aortic valve replacement, coronary artery bypass grafting for coronary artery disease is standard, but the appropriate revascularization strategy in patients undergoing TAVR is uncertain. Stress PET may identify patients that benefit from revascularization.
Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison. [2015]Pharmacologic stress myocardial CT perfusion (CTP) has been reported to be a viable imaging modality for detection of myocardial ischemia compared with single-photon emission CT (SPECT) in several single-center studies. However, regadenoson-stress CTP has not previously been compared with SPECT in a multicenter, multivendor study. The rationale and design of a phase 2, randomized, cross-over study of regadenoson-stress myocardial perfusion imaging by CTP compared with SPECT are described herein. The study will be conducted at approximately 25 sites by using 6 different CT scanner models, including 64-, 128-, 256-, and 320-slice systems. Subjects with known/suspected coronary artery disease will be randomly assigned to 1 of 2 imaging procedure sequences; rest and regadenoson-stress SPECT on day 1, then regadenoson-stress CTP and rest CTP/coronary CT angiography (same acquisition) on day 2; or regadenoson-stress CTP and rest CTP/CT angiography on day 1, then rest and regadenoson-stress SPECT on day 2. The prespecified primary analysis examines the agreement rate between CTP and SPECT for detecting or excluding ischemia (≥2 or 0-1 reversible defects, respectively), as assessed by 3 independent blinded readers for each modality. Non-inferiority will be indicated if the lower boundary of the 95% CI for the agreement rate is within 0.15 of 0.78 (the observed agreement rate in the regadenoson pivotal trials). The protocol described herein will support the first evaluation of regadenoson-stress CTP by using multiple scanner types compared with SPECT.
Relationship of 82Rb PET territorial myocardial asynchrony to arterial stenosis. [2021]Label="OBJECTIVE"> 82Rb PET/CT rest/regadenoson-stress data enable quantification of left ventricular rest and stress function, perfusion, and asynchrony. Our study was conducted to determine which parameters best identify patients with multi-vessel disease (MVD) and individual stenosed arteries.
Regadenoson pharmacologic rubidium-82 PET: a comparison of quantitative perfusion and function to dipyridamole. [2022]Dipyridamole is used for stress (82)rubidium chloride ((82)RbCl) PET because of its long hyperemic duration. Regadenoson has advantages of a fixed dose and favorable symptom profile, but its mean maximal hyperemia is only 2.3 minutes. To determine its suitability for (82)RbCl PET, we imaged subjects using a regadenoson protocol based on its hyperemic response and compared the images in the same subjects having dipyridamole PET.
Impact of pharmacological stress agent on patient motion during rubidium-82 myocardial perfusion PET/CT. [2019]Patient motion has been demonstrated to have a significant impact on the quality and accuracy of rubidium-82 myocardial perfusion PET/CT. This study aimed to investigate the effect on patient motion of two pharmacological stressing agents, adenosine and regadenoson.
Regadenoson stress for myocardial perfusion imaging. [2015]Noninvasive functional imaging plays a major role in the diagnosis of hemodynamically significant coronary artery disease (CAD) by means of the detection of abnormal myocardial perfusion. For this, cardiac stressors are essential as they induce hypoperfusion in the presence of flow-limiting coronary stenosis. Several pharmacological stressors are currently available and it is important that clinicians who are involved in the care and management of patients with CAD become familiar with their indications, contraindications and protocols. Among the primary coronary vasodilator agents, regadenoson is increasingly used as the default stressor or as an alternative to other modalities of stress. This article provides an updated review of regadenoson stress for the assessment of patients with suspected or known CAD and describes its pharmacological properties, stress protocol, efficacy and safety profile.
Current advances in vasodilator pharmacological stress perfusion imaging. [2017]More than 7 million stress perfusion studies are performed in the United States annually, 44% with pharmacological vasodilator stress agents. Both adenosine and dipyridamole are nonselective coronary vasodilators that are commonly used for stress perfusion imaging. These agents are safe and provide an effective means to diagnose coronary artery disease. A newer agent, regadenoson, is an adenosine receptor agonist that is selective for coronary vasodilation. Regadenoson is noninferior to adenosine for the detection of ischemia and is better tolerated by patients. Recent trials such as INSPIRE (Adenosine Sestamibi Post-Infarction Evaluation) and the COURAGE (Results from Clinical Outcomes Utilizing Revascularization and Aggressive Guideline-driven Drug Evaluation) Nuclear Imaging Substudy have established clearly that noninvasive risk stratification with vasodilator testing is an important and appropriate step in guiding medical therapy and invasive coronary intervention.
Detection of coronary stenosis with myocardial contrast echocardiography using regadenoson, a selective adenosine A2A receptor agonist. [2016]Regadenoson is comparable to adenosine in pharmacologic radionuclide stress tests but has not been studied with stress myocardial contrast echocardiography. This study assessed the haemodynamic profile and ability of regadenoson, a novel selective A(2A) receptor agonist, to detect coronary artery stenosis during myocardial contrast echocardiography.
A cost-effective sestamibi protocol in the managed health care era. [2019]In the managed health care era a need exists to lower the cost of diagnostic tests for coronary artery disease. One possible approach is to eliminate the rest study in the conventional stress-rest perfusion imaging protocol with single photon emission computed tomography.
Noninvasive pacemaker stress echocardiography for diagnosis of coronary artery disease: a multicenter study. [2019]We evaluated the feasibility, safety, and diagnostic accuracy of noninvasive pacemaker stress echocardiography (PASE) test as a potential alternative to exercise or pharmacologic stress in patients with suspected or known coronary artery disease (CAD).