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Sponsored by: |
Biosite |
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Information provided by: | Biosite |
ClinicalTrials.gov Identifier: | NCT00206830 |
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 IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment |
Official Title: | SHORTness of Breath In the Emergency Department (SHORTIE) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
diuretics, injectable anticoagulants, thrombolytics
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 |
Study ID Numbers: | 011 |
Study First Received: | September 13, 2005 |
Last Updated: | April 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00206830 History of Changes |
Health Authority: | United States: Institutional Review Board |
Heart Failure Heart Diseases Pulmonary Embolism Myocardial Ischemia Respiration Disorders Vascular Diseases Ischemia Thrombosis Signs and Symptoms Necrosis |
Embolism and Thrombosis Respiratory Tract Diseases Embolism Lung Diseases Emergencies Signs and Symptoms, Respiratory Infarction Dyspnea Myocardial Infarction |
Disease Attributes Heart Failure Heart Diseases Pulmonary Embolism Myocardial Ischemia Respiration Disorders Vascular Diseases Ischemia Signs and Symptoms Necrosis Embolism and Thrombosis |
Pathologic Processes Respiratory Tract Diseases Embolism Lung Diseases Emergencies Signs and Symptoms, Respiratory Cardiovascular Diseases Infarction Dyspnea Myocardial Infarction |