SHORTness of Breath In the Emergency Department (SHORTIE)

Heart Failure Clinical Trial

Official title:

SHORTness of Breath In the Emergency Department (SHORTIE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206830
• Other study ID #: 011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: July 23, 2015
• Start date: April 2005
• Est. completion date: August 2007

Study information

• Verified date: July 2015
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: August 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Dyspnea
• Heart Failure
• Myocardial Infarction
• Pulmonary Embolism

Intervention

Device:
• Triage Profiler S.O.B. Panel

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York
United States	Duke University Hospital Durham	Durham	North Carolina
United States	Hospital of the Univ. of Pennsylvania	Philadelphia	Pennsylvania
United States	Stony Brook University Hospital	Stony Brook	New York
United States	University of Massachusetts Medical Center USA	Worcester,	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to specific treatment for final diagnosis			No
Primary	Length of stay in the emergency department (ED)			No
Primary	ED and total hospital costs			No
Secondary	Outcome at 30 days (Phase I and II) and 90 days (Phase II)			No
Secondary	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.			No