This study is accepting new patients by invitation only

Abbott i-STAT High Sensitivity Troponin I Study

a study on Heart Attack

Summary

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

Description

Summary

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

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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

Locations

  • Zuckerberg San Francisco General Hospital and Trauma Center
    San Francisco California 94110 United States
  • Stanford Medical Center
    Stanford California 94305 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Abbott Point of Care
ID
NCT05629572
Study Type
Observational
Participants
Expecting 2800 study participants
Last Updated