Abbott i-STAT High Sensitivity Troponin I Study
Launched by ABBOTT POINT OF CARE · Nov 17, 2022
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect 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 s...
Gender
ALL
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)
About Abbott Point Of Care
Abbott Point of Care is a leading innovator in the development and commercialization of advanced diagnostic solutions that enhance patient care and clinical decision-making at the point of care. As a division of Abbott Laboratories, the organization focuses on delivering rapid, accurate testing technologies that empower healthcare professionals with timely insights. With a commitment to improving health outcomes, Abbott Point of Care leverages cutting-edge research and development to create user-friendly, portable devices that facilitate efficient diagnosis and monitoring across various settings, including hospitals, clinics, and remote locations. Their extensive portfolio of products exemplifies their dedication to advancing global health through precision diagnostics and streamlined workflows.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Kansas City, Kansas, United States
Houston, Texas, United States
Charleston, South Carolina, United States
Camden, New Jersey, United States
Columbus, Ohio, United States
Detroit, Michigan, United States
Philadelphia, Pennsylvania, United States
Indianapolis, Indiana, United States
Albuquerque, New Mexico, United States
Saint Louis, Missouri, United States
Tampa, Florida, United States
Charlottesville, Virginia, United States
Stanford, California, United States
Cincinnati, Ohio, United States
San Francisco, California, United States
Hershey, Pennsylvania, United States
Temple, Texas, United States
Chandler, Arizona, United States
San Francisco, California, United States
Minneapolis, Minnesota, United States
Redmond, Washington, United States
Winston Salem, North Carolina, United States
Chandler, Arizona, United States
Washington, District Of Columbia, United States
Louisville, Kentucky, United States
Las Vegas, Nevada, United States
Stony Brook, New York, United States
Dallas, Texas, United States
Minneapolis, Minnesota, United States
Stony Brook, New York, United States
Florence, South Carolina, United States
Patients applied
Trial Officials
Manish Gupta, MS, MBA
Study Director
Abbott Point of Care
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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