Abbott i-STAT High Sensitivity Troponin I Study

Last updated: September 3, 2024
Sponsor: Abbott Point of Care
Overall Status: Completed

Phase

N/A

Condition

Heart Defect

Circulation Disorders

Heart Disease

Treatment

i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity

Clinical Study ID

NCT05629572
CS-2020-0012
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is 18 years of age or older

  • Presenting to the Emergency Department (ED) with signs and symptoms suggestive ofAcute Coronary Syndrome (ACS): Acute chest, epigastric, neck, jaw or arm pain ordiscomfort or pressure without apparent non-cardiac source; Shortness of breath,nausea, vomiting, fatigue/malaise; Other equivalent discomfort suggestive of amyocardial infarction (MI) in accordance with the American College of CardiologyFoundation/American Heart Association Task Force on Practice Guidelines.

  • Electrocardiogram (ECG) ordered as part of the standard of care

Exclusion

Exclusion Criteria:

  • Previously enrolled in the study

  • Enrolled in any interventional clinical trial (within the last 30 days)

Study Design

Total Participants: 3697
Treatment Group(s): 1
Primary Treatment: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity
Phase:
Study Start date:
November 02, 2022
Estimated Completion Date:
March 11, 2024

Study 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.

Connect with a study center

  • Mercy Gilbert

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Mercy Gilbert Medical Center

    Chandler, Arizona 85224
    United States

    Site Not Available

  • University of California at San Francisco

    San Francisco, California 94110
    United States

    Site Not Available

  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California 94110
    United States

    Site Not Available

  • Stanford Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Geroge Washington University

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Kentucky Clinical Trials Labatory

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Hennepin Healthcare

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation)

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55906
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89012
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Stony Brook Medicine

    Stony Brook, New York 11974-8167
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook, New York 11974-8167
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27151
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Penn State University Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Florence Medical Centre (MUSC Health)

    Florence, South Carolina 29505
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390-8579
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor Scott and White Healthcare

    Temple, Texas 76508
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.