Clinical trial NCT00206830: SHORTness of Breath In the Emergency Department (SHORTIE)
Official title: SHORTness of Breath In the Emergency Department (SHORTIE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Myocardial Infarction
Heart Failure
Pulmonary Embolism
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Time to specific treatment for final diagnosis
measure: Length of stay in the emergency department (ED)
measure: ED and total hospital costs
Secondary outcomes:
measure: Outcome at 30 days (Phase I and II) and 90 days (Phase II)
measure: 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.
Other outcomes:
Locations:
city: Worcester,
country: United States
facility: University of Massachusetts Medical Center USA
state: Massachusetts
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Hospital Durham
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the Univ. of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: VA, University of California, San Diego
name: Alan Maisel, MD
role: PRINCIPAL_INVESTIGATOR
References: