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Completed
NCT05629572
Abbott i-STAT High Sensitivity Troponin I Study
Conditions: Myocardial Infarction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3697
Sponsor: Abbott Point of Care
Location: Mercy Gilbert Medical Center Chandler Arizona
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT05629572). StuddyBuddy aggregates publicly available trial information.