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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
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

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of New Mexico
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AlbuquerqueUnited StatesUnknown status
Cooper University Hospital
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CamdenUnited StatesUnknown status
Mercy Gilbert Medical Center
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ChandlerUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
University of Cincinnati Medical Center
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CincinnatiUnited StatesUnknown status
Ohio State University Medical Center
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Florence Medical Centre (MUSC Health)
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FlorenceUnited StatesUnknown status
Penn State University Hershey Medical Center
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HersheyUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
University Medical Center of Southern Nevada
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Las VegasUnited StatesUnknown status
Kentucky Clinical Trials Labatory
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LouisvilleUnited StatesUnknown status
Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation)
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MinneapolisUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
Eastside Research Associates
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RedmondUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University of California at San Francisco
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San FranciscoUnited StatesUnknown status
Stanford Medical Center
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StanfordUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Stony Brook University
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Stony BrookUnited StatesUnknown status
Tampa General Hospital
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TampaUnited StatesUnknown status
Baylor Scott and White Healthcare
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TempleUnited StatesUnknown status
Geroge Washington University
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Washington D.C.United StatesUnknown status
Wake Forest Baptist Health
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.