CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 550 enrolled
Drug / intervention
Webtooldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01059500
NCT01059500N/ACompleted

Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED

Wake Forest University Health Sciences·interventional·Posted Feb 1, 2010·Updated Mar 23, 2023

In Brief

A clinical study evaluating Webtool for Acute Coronary Syndrome and Pulmonary Embolism. Completed, enrolled 550 participants across 4 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2010
Enrollment StartJan 1, 2010
Primary CompletionMay 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.4 years ago

Interventions

Webtooldevice

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.