Assessment of Acute Disease to Reduce Imaging Costs

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients

NCT03083093

CTEPH Pulmonary Embolism Early Diagnosis

COMPLETED

CTEPH Predictors Following Acute Pulmonary Embolism

NCT05784896

CTEPH Predictors

UNKNOWN

Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism

NCT03729492

Chronic Thromboembolic Pulmonary Disease

UNKNOWN NA

Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

NCT02035293

Chronic Obstructive Pulmonary Disease Patients Hospitalized for a COPD Exacerbation

COMPLETED NA

MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism

NCT05879380

Pulmonary Embolism Radiation Exposure

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome Pulmonary Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Webtool Output

The webtool output group will receive the numeric PTP estimate from webtool output.

Group Type EXPERIMENTAL

Webtool

Intervention Type DEVICE

Webtool provides the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP \<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP \>5.5%: proceed to provocative testing. For PE, PTP\<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP\>20% consider empiric anticoagulation with heparin if no contraindications.

Standard of Care/No Webtool Output

The control group will not receive the numeric PTP estimate.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Webtool

Webtool provides the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP \<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP \>5.5%: proceed to provocative testing. For PE, PTP\<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP\>20% consider empiric anticoagulation with heparin if no contraindications.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No