SHORTness of Breath In the Emergency Department (SHORTIE)

Phase 2

Completed

• Conditions: Acute Myocardial Infarction; Pulmonary Embolism; Heart Failure

• Registration Number: NCT00206830
• Lead Sponsor: Abbott RDx Cardiometabolic

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-08
• Study Completion: 2007-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

University of Massachusetts Medical Center USA; 🇺🇸 Worcester,, Massachusetts, United States

New York Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States

Duke University Hospital Durham; 🇺🇸 Durham, North Carolina, United States

Hospital of the Univ. of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States