SHORTness of Breath In the Emergency Department (SHORTIE)

NCT00206830 | Completed Phase 2

• 1 other identifier: 011
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Myocardial Infarction; Heart Failure; Pulmonary Embolism

Outcome Measures

Primary Outcomes (3)

• Time to specific treatment for final diagnosis

• Length of stay in the emergency department (ED)

• ED and total hospital costs

Secondary Outcomes (2)

• 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.

Study Arms (2)

Control-Blinded from Results

NO INTERVENTION

Access to Results

EXPERIMENTAL

Device: Triage Profiler S.O.B. Panel

Interventions

Triage Profiler S.O.B. Panel DEVICE

Access to Results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott RDx Cardiometabolic: lead

Study Sites (5)

University of Massachusetts Medical Center USA

Worcester, Massachusetts, 01655, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Duke University Hospital Durham

Durham, North Carolina, 27710, United States

Location

Hospital of the Univ. of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Alan Maisel, MD

  VA, University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2007
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

US (5)