Abbott i-STAT High Sensitivity Troponin I Study

NCT05629572 | Completed FDA Device

• 1 other identifier: CS-2020-0012
• Study Type: observational
• Target: 3,697
• Locations: 1 country
• Sites: 28

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Performance of i-STAT hs-TnI cartridge

  Performance metrics calculated using adjudicated outcomes with the hs-TnI test results.

  Up to 9 hours

Study Arms (1)

Prospective subjects in Emergency Department (ED) with symptoms of acute coronary syndrome (ACS).

Prospectively collected whole blood specimens from subjects presenting to the emergency department (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS). For this study's MI adjudication, a minimum of 2 samples are to be tested on the site's standard of care (SOC) instrument, one at baseline and one at another time point (T1, T2, T3). For each of the SOC test results, a corresponding research draw for testing on the i-STAT hs-TnI cartridge should be attempted, if feasible. For research, a minimum of 2 samples are to be tested on i-STAT instruments, one at baseline and one at an additional timepoint. Enrollment will be monitored throughout the clinical study.

Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity

Interventions

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

Paired whole blood and plasma samples collected at multiple time points.

Prospective subjects in Emergency Department (ED) with symptoms of acute coronary syndrome (ACS).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population consisted of subjects presenting to emergency departments (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS) and had an electrocardiogram (ECG) ordered as part of their standard of care (SOC).

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)

Sponsors & Collaborators

• Abbott Point of Care: lead

Study Sites (28)

Mercy Gilbert Medical Center

Chandler, Arizona, 85224, United States

Location

University of California at San Francisco

San Francisco, California, 94110, United States

Location

Stanford Medical Center

Stanford, California, 94305, United States

Location

Geroge Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kentucky Clinical Trials Labatory

Louisville, Kentucky, 40202, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation)

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55906, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89012, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Stony Brook University

Stony Brook, New York, 11974-8167, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27151, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Penn State University Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Florence Medical Centre (MUSC Health)

Florence, South Carolina, 29505, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8579, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor Scott and White Healthcare

Temple, Texas, 76508, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

Related Publications (6)

• 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.

  PMID: 10952834 BACKGROUND

• 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.

  PMID: 10987629 BACKGROUND

• 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.

  PMID: 30153967 BACKGROUND

• Sharma S, Jackson PG, Makan J. Cardiac troponins. J Clin Pathol. 2004 Oct;57(10):1025-6. doi: 10.1136/jcp.2003.015420. No abstract available.

  PMID: 15452153 BACKGROUND

• Alushi B, Jost-Brinkmann F, Kastrati A, Cassese S, Fusaro M, Stangl K, Landmesser U, Thiele H, Lauten A. High-Sensitivity Cardiac Troponin T in Patients with Severe Chronic Kidney Disease and Suspected Acute Coronary Syndrome. J Clin Med. 2021 Sep 17;10(18):4216. doi: 10.3390/jcm10184216.

  PMID: 34575325 BACKGROUND

• Wu AHB, Mahler SA, House SL, Jortani SA, Creer MH, Rising KL, Bischof JJ, Crystal C, Headden GF, Apple FS, Harrison NE, Meltzer AC, Baca JT, Tiffany B, Sochor M, Pentecostes GU, Di Tullio KP, Gupta MS, Singer AJ, Januzzi JL. Clinical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay. J Appl Lab Med. 2026 Jan 5;11(1):98-112. doi: 10.1093/jalm/jfaf152.

  PMID: 41146629 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lithium Heparin (LiH) plasma stored in cryovial.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Manish Gupta, MS, MBA

  Abbott Point of Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 29, 2022
• Study Start: November 2, 2022
• Primary Completion: February 6, 2024
• Study Completion: March 11, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (28)