NCT04772157

Safe Emergency Department DIscharGE Rate (SEIGE)

Evaluation of the Siemens POC HS CTn-I Test System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Hennepin Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The Siemens POC High Sensitivity Troponin-I Test System is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTn-I) in fresh human capillary (fingerstick) whole blood, and lithium-heparinized venous whole blood or plasma, to be used by healthcare professionals at the point of care (POC) as well as in the clinical laboratory. The Siemens POC High Sensitivity Troponin-I Test System is to be used as an aid in the diagnosis of myocardial infarction (MI).

Detailed description

Study purpose/objective: * Evaluate the clinical performance of the Siemens POC HS cTn-I test system for the diagnosis and rule out of AMI in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication. * Correlate the blood and plasma outcomes on the Siemens POC HS cTn-I test system as function of the corresponding hematocrit (Hct) values. Hypothesis: The Siemens POC HS cTn-I Test System 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

• Acute Myocardial Infarction
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac Troponin Testing	Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-10-13
• Completion: 2024-10-13
• First posted: 2021-02-26
• Last updated: 2024-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study