SHORTness of Breath In the Emergency Department (SHORTIE)
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | SHORTness of Breath In the Emergency Department (SHORTIE) |
- Time to specific treatment for final diagnosis
- Length of stay in the emergency department (ED)
- ED and total hospital costs
- 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: | 1050 |
| Study Start Date: | April 2005 |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Principal Investigator: | Alan Maisel, MD | VA, University of California, San Diego |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00206830 History of Changes |
| Other Study ID Numbers: | 011 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 28, 2006 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dyspnea Embolism Emergencies Heart Failure Infarction Myocardial Infarction Pulmonary Embolism Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Disease Attributes Pathologic Processes Heart Diseases Ischemia Necrosis Myocardial Ischemia Lung Diseases |
ClinicalTrials.gov processed this record on May 16, 2013