NCT05629572

Abbott i-STAT High Sensitivity Troponin I Study

Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,697 (actual)
• Sponsor: Abbott Point of Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity	Paired whole blood and plasma samples collected at multiple time points.

Timeline

• Start date: 2022-11-02
• Primary completion: 2024-02-06
• Completion: 2024-03-11
• First posted: 2022-11-29
• Last updated: 2024-09-19

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated device study