Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Myocardial Infarction, Infarction, i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Previously enrolled in the study
  • Enrolled in any interventional clinical trial (within the last 30 days)

Locations

  • University of California at San Francisco
    San Francisco California 94110 United States
  • Stanford Medical Center
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Point of Care
ID
NCT05629572
Study Type
Observational
Participants
About 3697 people participating
Last Updated