Abbott i-STAT High Sensitivity Troponin I Study

Completed

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT05629572

Run by

Abbott Point of Care

People needed

3697

Starts

2022-11-02

Expected to finish

2024-03-11

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Mercy Gilbert Medical Center — Chandler, Arizona, United States
• University of California at San Francisco — San Francisco, California, United States
• Stanford Medical Center — Stanford, California, United States
• Geroge Washington University — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kentucky Clinical Trials Labatory — Louisville, Kentucky, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation) — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University Medical Center of Southern Nevada — Las Vegas, Nevada, United States
• Cooper University Hospital — Camden, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Stony Brook University — Stony Brook, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Penn State University Hershey Medical Center — Hershey, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Florence Medical Centre (MUSC Health) — Florence, South Carolina, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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