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SHORTness of Breath In the Emergency Department (SHORTIE)

Primary Purpose

Acute Myocardial Infarction, Heart Failure, Pulmonary Embolism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Triage Profiler S.O.B. Panel
Sponsored by
Biosite
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Massachusetts Medical Center USA
  • New York Methodist Hospital
  • Stony Brook University Hospital
  • Duke University Hospital Durham
  • Hospital of the Univ. of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control-Blinded from Results

Access to Results

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2005
Last Updated
July 23, 2015
Sponsor
Biosite
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1. Study Identification

Unique Protocol Identification Number
NCT00206830
Brief Title
SHORTness of Breath In the Emergency Department (SHORTIE)
Official Title
SHORTness of Breath In the Emergency Department (SHORTIE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biosite

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Heart Failure, Pulmonary Embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
306 (false)

8. Arms, Groups, and Interventions

Arm Title
Control-Blinded from Results
Arm Type
No Intervention
Arm Title
Access to Results
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Triage Profiler S.O.B. Panel
Primary Outcome Measure Information:
Title
Time to specific treatment for final diagnosis
Title
Length of stay in the emergency department (ED)
Title
ED and total hospital costs
Secondary Outcome Measure Information:
Title
Outcome at 30 days (Phase I and II) and 90 days (Phase II)
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Maisel, MD
Organizational Affiliation
VA, University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical Center USA
City
Worcester,
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Hospital Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hospital of the Univ. of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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