Abbott i-STAT High Sensitivity Troponin I Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or older Presenting to the ED with signs and symptoms suggestive of 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 an MI (in accordance with the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adjudicated MI<br>Prospectively collected whole blood specimens from subjects presenting to the ED with chest discomfort or equivalent ischemic symptoms suggestive of ACS. For this study's MI adjudication, a minimum of 2 samples are to be tested on the site's standard of care (SOC) instrument, one at baseline and one at another time point (T1, T2, T3). For each of the SOC test results, a corresponding research draw for testing on the i-STAT hs-TnI cartridge should be attempted, if feasible. For research, a minimum of 2 samples are to be tested on i-STAT instruments, one at baseline and one at an additional timepoint. Enrollment will be monitored throughout the clinical study. | Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity<br>* Paired whole blood and plasma samples collected at multiple time points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) |  | 9 hours |