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NCT05629572: i-STAT hs-TnI

Abbott i-STAT High Sensitivity Troponin I Study

Completed Last updated 19 September 2024
What this trial tests

trial testing i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity in Myocardial Infarction in 3,697 participants. Completed in 11 March 2024.

Timeline
2 November 2022
Primary endpoint
6 February 2024
11 March 2024

Quick facts

Lead sponsorAbbott Point of Care
StatusCompleted
Study typeOBSERVATIONAL
Enrollment3,697
Start date2 November 2022
Primary completion6 February 2024
Estimated completion11 March 2024
Sites28 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Abbott Point of Care

Who can join

18 and older, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay.
    Wu AHB, Mahler SA, House SL, Jortani SA, et al · · 2026 · cited 1× · PMID 41146629 · DOI 10.1093/jalm/jfaf152

Verify or expand the search:

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other Abbott Point of Care trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05629572.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing