Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-26 @ 8:28 PM
Study NCT ID:
NCT04772157
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Emergency Department DIscharGE Rate (SEIGE)
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Study Overview
Official Title:
Evaluation of the Siemens POC HS CTn-I Test System
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEIGE
Brief 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).
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: