Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05629572
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2022-11-11
Brief Title:
Abbott i-STAT High Sensitivity Troponin I Study
Sponsor:
Abbott Point of Care
Organization:
Abbott Point of Care
Study Overview
Official Title:
Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction MI
Status:
COMPLETED
Status Verified Date:
2024-09
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:
i-STAT hs-TnI
Brief Summary:
The goal of this observational multi-center study is to evaluate the clinical performance of the i-STAT hs-TnI test i-STAT High Sensitivity Troponin I using the investigational i-STAT hs-TnI cartridge for the proposed intended use as an aid in the diagnosis and treatment of myocardial infarction MI The cartridge measures cardiac troponin I cTnI in whole blood or plasma samples using the i-STAT 1 Analyzer or i-STAT Alinity Instrument Subjects presenting to the emergency department ED with chest discomfort or equivalent ischemic symptoms suggestive of Acute Coronary Syndrome ACS who are enrolled in this study will be asked to provide blood samples for testing
Detailed Description:
The i-STAT High Sensitivity Troponin I i-STAT hs-TnI test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I cTnI in whole blood or plasma samples using the i-STAT 1 Analyzer or i-STAT Alinity Instrument in point of care or clinical laboratory settings The hs-TnI test is intended to be used as an aid in the diagnosis of myocardial infarction MI
The objective of this study is to evaluate the clinical performance of the i-STAT hs-TnI test using the investigational i-STAT hs-TnI Cartridge with the i-STAT 1 Analyzer and i-STAT Alinity Instrument for subjects presenting to the emergency department ED with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome ACS
The clinical evaluation will use prospectively collected whole blood specimens from subjects presenting to the ED with chest discomfort or equivalent ischemic symptoms suggestive of ACS
The objective of this study is to evaluate the clinical performance of the i-STAT hs-TnI test using the investigational i-STAT hs-TnI Cartridge with the i-STAT 1 Analyzer and i-STAT Alinity Instrument for subjects presenting to the emergency department ED with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome ACS
The clinical evaluation will use prospectively collected whole blood specimens from subjects presenting to the ED with chest discomfort or equivalent ischemic symptoms suggestive of ACS
Study Oversight
Has Oversight DMC:
None
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?:
None