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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-Blinded from Results | No Intervention | ||
| Access to Results | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triage Profiler S.O.B. Panel | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to specific treatment for final diagnosis | ||
| Length of stay in the emergency department (ED) | ||
| ED and total hospital costs |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Maisel, MD | VA, University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical Center USA | Worcester | Massachusetts | 01655 | United States | ||
| New York Methodist Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Brooklyn |
| New York |
| 11215 |
| United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Duke University Hospital Durham | Durham | North Carolina | 27710 | United States |
| Hospital of the Univ. of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| D004617 |
| Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |