Abbott i-STAT High Sensitivity Troponin I Study
- Conditions
- Myocardial Infarction
- Interventions
- Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity
- Registration Number
- NCT05629572
- Lead Sponsor
- Abbott Point of Care
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3697
- 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
- Previously enrolled in the study
- Enrolled in any interventional clinical trial (within the last 30 days)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective subjects in Emergency Department (ED) with symptoms of acute coronary syndrome (ACS). i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity Prospectively collected whole blood specimens from subjects presenting to the emergency department (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS). For this study's MI adjudication, a minimum of 2 samples are to be tested on the site's standard of care (SOC) instrument, one at baseline and one at another time point (T1, T2, T3). For each of the SOC test results, a corresponding research draw for testing on the i-STAT hs-TnI cartridge should be attempted, if feasible. For research, a minimum of 2 samples are to be tested on i-STAT instruments, one at baseline and one at an additional timepoint. Enrollment will be monitored throughout the clinical study.
- Primary Outcome Measures
Name Time Method Performance of i-STAT hs-TnI cartridge Up to 9 hours Performance metrics calculated using adjudicated outcomes with the hs-TnI test results.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Kentucky Clinical Trials Labatory
🇺🇸Louisville, Kentucky, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Stanford Medical Center
🇺🇸Stanford, California, United States
Mercy Gilbert Medical Center
🇺🇸Chandler, Arizona, United States
Geroge Washington University
🇺🇸Washington, District of Columbia, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Penn State University Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Florence Medical Centre (MUSC Health)
🇺🇸Florence, South Carolina, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation)
🇺🇸Minneapolis, Minnesota, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Baylor Scott and White Healthcare
🇺🇸Temple, Texas, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States