SHORTness of Breath In the Emergency Department (SHORTIE)

NCT ID: NCT00206830

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-08-31

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.

Conditions

Acute Myocardial Infarction; Heart Failure; Pulmonary Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Control-Blinded from Results

Group Type: NO_INTERVENTION

No interventions assigned to this group

Access to Results

Group Type: EXPERIMENTAL

Triage Profiler S.O.B. Panel

Intervention Type: DEVICE

Interventions

Triage Profiler S.O.B. Panel

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott RDx Cardiometabolic

OTHER

Sponsor Role: lead

Principal Investigators

Alan Maisel, MD

Role: PRINCIPAL_INVESTIGATOR

VA, University of California, San Diego

Locations

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

Countries

United States

Other Identifiers

011

Identifier Type: -

Identifier Source: org_study_id