Abbott i-STAT High Sensitivity Troponin I Study

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT05629572
• Lead Sponsor: Abbott Point of Care

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-11-02
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Primary Completion: 2024-02-06
• Study Completion: 2024-03-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3697

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of i-STAT hs-TnI cartridge	Up to 9 hours	Performance metrics calculated using adjudicated outcomes with the hs-TnI test results.

Trial Locations

Locations (28)

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, 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

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