Assessment of Acute Disease to Reduce Imaging Costs

Completed · Not applicable

Conditions studied: Acute Coronary Syndrome, Pulmonary Embolism

In brief

Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation, intravenous contrast and anticoagulation. This project addresses question of whether quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients with charted evidence of chest pain and dyspnea. After a validation phase, the main study will randomize patients to either the Standard care group or the Intervention group, which will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.

Key facts

Study ID

NCT01059500

Run by

Wake Forest University Health Sciences

People needed

550

Starts

2010-01-01

Expected to finish

2013-02-01

Last updated by the study team

2023-03-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (>17 years) ED patient reports a history of chest discomfort and new or worsened shortness of breath or breathing difficulty, documented in the written history of present illness or review of systems.
• Patient must understand English or have a certified translator present.
• Physician has ordered or plans to order a 12-lead electrocardiogram.
• Patient indicates the site hospital was his or her "hospital of choice" in the event of return visit within 14 days.
• Randomization Exclusions
• Positive urine cocaine test.
• Incarceration within 14 days of enrollment.
• Patient elopement from medical care (i.e., patients who leave against medical advice).

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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