Acute Myocardial Infarction, Heart Failure, Pulmonary Embolism
Conditions
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.
Interventions
DEVICETriage Profiler S.O.B. Panel
Sponsors
Abbott RDx Cardiometabolic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to specific treatment for final diagnosis | — |
| Length of stay in the emergency department (ED) | — |
| ED and total hospital costs | — |
Secondary
| Measure | 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. | — |
Countries
United States
Outcome results
None listed