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NCT05629572 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design

Related Conditions & MeSH terms

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
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