Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03972774
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2019-05-31
Brief Title:
Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCURATE
Brief 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 ie billed at 5000scan average receivable revenue 1500-2000scan 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 70-150scan 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 ie 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 CACS1 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 ie 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 100000 per quality-adjusted life year compared to a CAC-first strategy for screening suspectedpossible coronary artery disease
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 100000 per quality-adjusted life year compared to a CAC-first strategy for screening suspectedpossible coronary artery disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None