At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI)
In Brief
An observational study evaluating i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity for Myocardial Infarction. Completed, enrolled 3,697 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
Paired whole blood and plasma samples collected at multiple time points.