Myocardial Infarction
Conditions
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.
Interventions
DIAGNOSTIC_TESTi-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity
Paired whole blood and plasma samples collected at multiple time points.
Sponsors
Abbott Point of Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 18 years of age or older * Presenting to the Emergency Department (ED) with signs and symptoms suggestive of Acute Coronary Syndrome (ACS): Acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without apparent non-cardiac source; Shortness of breath, nausea, vomiting, fatigue/malaise; Other equivalent discomfort suggestive of a myocardial infarction (MI) in accordance with the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. * Electrocardiogram (ECG) ordered as part of the standard of care
Exclusion criteria
* Previously enrolled in the study * Enrolled in any interventional clinical trial (within the last 30 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of i-STAT hs-TnI cartridge | Up to 9 hours | Performance metrics calculated using adjudicated outcomes with the hs-TnI test results. |
Countries
United States
Outcome results
None listed