Abbott i-STAT High Sensitivity Troponin I Study
Public ClinicalTrials.gov record NCT05629572. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05629572
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3,697 participants
Conditions and interventions
Conditions
Interventions
- i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2022
- Primary completion
- Feb 5, 2024
- Completion
- Mar 10, 2024
- Last update posted
- Sep 18, 2024
2022 – 2024
United States locations
- U.S. sites
- 28
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mercy Gilbert Medical Center | Chandler | Arizona | 85224 | — |
| University of California at San Francisco | San Francisco | California | 94110 | — |
| Stanford Medical Center | Stanford | California | 94305 | — |
| Geroge Washington University | Washington D.C. | District of Columbia | 20037 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Kentucky Clinical Trials Labatory | Louisville | Kentucky | 40202 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation) | Minneapolis | Minnesota | 55404 | — |
| Mayo Clinic | Rochester | Minnesota | 55906 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89012 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Stony Brook University | Stony Brook | New York | 11974-8167 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27151 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Penn State University Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Florence Medical Centre (MUSC Health) | Florence | South Carolina | 29505 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8579 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Baylor Scott and White Healthcare | Temple | Texas | 76508 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Eastside Research Associates | Redmond | Washington | 98052 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05629572, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2024 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05629572 live on ClinicalTrials.gov.