Abbott i-STAT High Sensitivity Troponin I Study

Myocardial Infarction Clinical Trial

— i-STAT hs-TnI  

Official title:

Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05629572
• Other study ID #: CS-2020-0012
• Status: Active, not recruiting
• Start date: November 4, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Abbott Point of Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3697
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity
Paired whole blood and plasma samples collected at multiple time points.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Point of Care

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, de Feyter PJ, Specchia G, Ruzyllo W. Management of acute coronary syndromes: acute coronary syndromes without persistent ST segment elevation; recommendations of the Task Force of the European Society of Cardiology. Eur Heart J. 2000 Sep;21(17):1406-32. doi: 10.1053/euhj.2000.2301. No abstract available. — View Citation

Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2000 Sep;36(3):970-1062. doi: 10.1016/s0735-1097(00)00889-5. No abstract available. Erratum In: J Am Coll Cardiol 2001 Jul;38(1):294-5. — View Citation

Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of i-STAT hs-TnI cartridge	Performance metrics calculated using adjudicated outcomes with the hs-TnI test results.	Up to 9 hours