NCT05629572Completed
Abbott i-STAT High Sensitivity Troponin I Study
Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI)
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3697 (actual)
- First submitted
- 11 Nov 2022
- Start date
- 2 Nov 2022
- Primary completion date
- 6 Feb 2024
- Lead sponsor
- Abbott Point of Care
- Diseases
- Coronary artery disease
- NCT number
- NCT05629572
What you commit to
- Study type: Observational
- Participants enrolled: 3697
- From 2 Nov 2022 to the primary completion date, 6 Feb 2024
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously enrolled in the study
Other
- Enrolled in any interventional clinical trial (within the last 30 days)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Cooper University Hospital Coordinator of this site? Confirm its status | Camden | United States | Unknown status |
| Mercy Gilbert Medical Center Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Ohio State University Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Florence Medical Centre (MUSC Health) Coordinator of this site? Confirm its status | Florence | United States | Unknown status |
| Penn State University Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Kentucky Clinical Trials Labatory Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation) Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Eastside Research Associates Coordinator of this site? Confirm its status | Redmond | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California at San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Stanford Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stony Brook University Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Baylor Scott and White Healthcare Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
| Geroge Washington University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Wake Forest Baptist Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.