Skip to main content
OpenTrials
Completed

NCT Number: NCT00206830

SHORTness of Breath In the Emergency Department (SHORTIE)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Massachusetts Medical Center USA, Worcester, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triage Profiler S.O.B. Panel

Device

Primary outcomes

  1. Time to specific treatment for final diagnosis

  2. Length of stay in the emergency department (ED)

  3. ED and total hospital costs

Secondary outcomes

  1. Outcome at 30 days (Phase I and II) and 90 days (Phase II)

  2. 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.

Sponsors and collaborators

Lead sponsor

Abbott RDx Cardiometabolic

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.