SHORTness of Breath In the Emergency Department (SHORTIE)

July 23, 2015 updated by: Biosite
SHORTIE is a two-phase study to determine the impact of the Triage Profiler S.O.B. (Shortness Of Breath) Panel on patient management, outcome, and cost.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients presenting to the ED with a primary complaint of shortness of breath will a have blood sample collected at enrollment and tested using the Triage® Profiler S.O.B. Panel (measuring creatine kinase MB [CK-MB], myoglobin, troponin I, B-type natriuretic peptide [BNP], D-dimer). The test is used as an aid in the diagnosis of myocardial infarction (MI), an aid in the diagnosis and assessment of severity of heart failure (HF), and an aid in the assessment and evaluation of disseminated intravascular coagulation including pulmonary embolism (PE). Phase I is an observational study and results of the Triage Profiler S.O.B. panel will be blinded to all attending physicians and health care workers. In Phase II, patients will be assigned to either the experimental arm or the control arm of the study. In the experimental arm, the Triage Profiler S.O.B. Panel results will be available to the treating physician and can be incorporated into the decision making process. In the control arm, treating physicians and staff will be blinded to the Triage Profiler S.O.B. Panel results. Time to appropriate treatment, length of ED stay, patient outcome and hospital costs will be assessed in all patients and used to determine the impact of Triage Profiler S.O.B Panel on these parameters. Furthermore, the diagnostic accuracy of the Triage Profiler S.O.B Panel will be calculated.

Study Type

Interventional

Enrollment

306

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester,, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center USA
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital Durham
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the Univ. of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 and older.
  • Visit to the ED is due to a primary complaint of shortness of breath alone or shortness of breath with associated chest pain, cough or edema.

Exclusion Criteria:

  • Blood sample cannot be collected before treatment is initiated, specifically CPR or treatment with i.v. diuretics, injectable anticoagulants, thrombolytics
  • Patient is unwilling or unable to give consent to participate in the study
  • Patient has renal disease requiring dialysis
  • Patients with a clear exacerbation of isolated asthma
  • Patients with trauma that interferes with normal breathing function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control-Blinded from Results
Experimental: Access to Results
Device: Triage Profiler S.O.B. Panel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to specific treatment for final diagnosis
Length of stay in the emergency department (ED)
ED and total hospital costs

Secondary Outcome Measures

Outcome Measure
Outcome at 30 days (Phase I and II) and 90 days (Phase II)
Diagnostic accuracy of the Triage® Profiler S.O.B. panel for acute myocardial infarction (AMI), heart failure (HF) and pulmonary embolism (PE) in patients presenting with S.O.B.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosite

Investigators

  • Principal Investigator: Alan Maisel, MD, VA, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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