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SHORTness of Breath In the Emergency Department (SHORTIE)

This study has been completed.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00206830
First received: September 13, 2005
Last updated: July 23, 2015
Last verified: July 2015
  Purpose
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.

Condition Intervention Phase
Acute Myocardial Infarction Heart Failure Pulmonary Embolism Device: Triage Profiler S.O.B. Panel Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: SHORTness of Breath In the Emergency Department (SHORTIE)

Resource links provided by NLM:


Further study details as provided by Biosite:

Primary Outcome Measures:
  • Time to specific treatment for final diagnosis
  • Length of stay in the emergency department (ED)
  • ED and total hospital costs

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 306
Study Start Date: April 2005
Study Completion Date: August 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control-Blinded from Results
Experimental: Access to Results Device: Triage Profiler S.O.B. Panel

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206830

Locations
United States, Massachusetts
University of Massachusetts Medical Center USA
Worcester,, Massachusetts, United States, 01655
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Hospital Durham
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Hospital of the Univ. of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: Alan Maisel, MD VA, University of California, San Diego
  More Information

ClinicalTrials.gov Identifier: NCT00206830     History of Changes
Other Study ID Numbers: 011
Study First Received: September 13, 2005
Last Updated: July 23, 2015

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Emergencies
Embolism
Pulmonary Embolism
Dyspnea
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Disease Attributes
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 23, 2017