Trials / Completed
CompletedNCT04280926
Use of High Sensitivity Cardiac Troponin in Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction
Use of High Sensitivity Cardiac Troponin in Safely Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction (SAFETY)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (actual)
- Sponsor
- Hennepin Healthcare Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Detailed description
Background: Studies addressing the clinical performance of the Siemens Healthineers High-Sensitivity Troponin I assay (TnIH) on the Atellica IM analyzer for the diagnosis and rule out of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking. Study objective: Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication. Hypothesis: The Atellica IM TnIH assay will offer an excellent diagnostic performance for acute myocardial injury and acute myocardial infarction, as well as expedite the risk stratification of patients for early discharge from the emergency department.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Cardiac Troponin Testing | Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers). |
Timeline
- Start date
- 2020-10-13
- Primary completion
- 2021-10-13
- Completion
- 2024-10-13
- First posted
- 2020-02-21
- Last updated
- 2024-12-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04280926. Inclusion in this directory is not an endorsement.