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Abbott i-STAT High Sensitivity Troponin I Study
Sponsor: Abbott Point of Care
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3697
Start Date
2022-11-02
Completion Date
2024-03-11
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity
Paired whole blood and plasma samples collected at multiple time points.
Locations (28)
Mercy Gilbert Medical Center
Chandler, Arizona, United States
University of California at San Francisco
San Francisco, California, United States
Stanford Medical Center
Stanford, California, United States
Geroge Washington University
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kentucky Clinical Trials Labatory
Louisville, Kentucky, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation)
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Cooper University Hospital
Camden, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Stony Brook University
Stony Brook, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Penn State University Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Florence Medical Centre (MUSC Health)
Florence, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Baylor Scott and White Healthcare
Temple, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Eastside Research Associates
Redmond, Washington, United States