Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3697 participants
OBSERVATIONAL
2022-11-02
2024-03-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Enrolled in any interventional clinical trial (within the last 30 days)
18 Years
ALL
No
Sponsors
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Abbott Point of Care
INDUSTRY
Responsible Party
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Principal Investigators
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Manish Gupta, MS, MBA
Role: STUDY_DIRECTOR
Abbott Point of Care
Locations
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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
Baylor Scott and White Healthcare
Temple, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Eastside Research Associates
Redmond, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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. 2025 Oct 28:jfaf152. doi: 10.1093/jalm/jfaf152. Online ahead of print.
Other Identifiers
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CS-2020-0012
Identifier Type: -
Identifier Source: org_study_id
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