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NCT03972774 · ClinicalTrials.gov registry record · NA

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

A NA study of Coronary Artery Disease, sponsored by Intermountain Health Care.

Recruiting
Registry status
NA
Development phase
2,500
Enrollment target
1
Study location

NCT03972774 is a NA study of Coronary Artery Disease that is actively recruiting participants, run by Intermountain Health Care. The registered enrollment target is 2,500 participants, above the 1,276-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT03972774, a NA study of Coronary Artery Disease, is actively recruiting participants, sponsored by Intermountain Health Care.

RECRUITING
Registry status
NA
Development phase
2,500 participants
Enrollment target
1
Study location

Study 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 (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

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST PET Stress Test
  • OTHER Non-PET Medical Management

Study Locations (1)

Utah

  • Intermountain Healthcare Hospitals and Clinics - Salt Lake City

Trial Details

FieldValue
Enrollment Target 2,500 participants
Start Date 2019-11-19
Est. Completion 2029-11
Phase NA

Sponsor

Intermountain Health Care

85 total trials

What the Registry Record Tells You About NCT03972774

The ClinicalTrials.gov registry entry for NCT03972774 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,276-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% higher). The listed sponsor is Intermountain Health Care, which has 85 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which PET Stress Test is the first listed.

NCT03972774 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.

Frequently Asked Questions

What is clinical trial NCT03972774 about?

NCT03972774 is a clinical study titled "Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach.". 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 p...

What is the current status of trial NCT03972774?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,500 participants. The study started on 2019-11-19. Estimated completion is 2029-11.

What conditions does trial NCT03972774 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT03972774?

The interventions under investigation include: PET Stress Test (DIAGNOSTIC_TEST), Non-PET Medical Management (OTHER).

Who is sponsoring clinical trial NCT03972774?

This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03972774 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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