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NCT05629572 · ClinicalTrials.gov registry record

Abbott i-STAT High Sensitivity Troponin I Study

A clinical trial, sponsored by Abbott Point of Care.

Completed
Registry status
3,697
Enrollment target

NCT05629572: Completed study, sponsored by Abbott Point of Care.

NCT05629572 is a clinical trial that has completed, run by Abbott Point of Care. The registered enrollment target is 3,697 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05629572 has completed, sponsored by Abbott Point of Care.

COMPLETED
Registry status
3,697 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

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

Trial Details

FieldValue
Enrollment Target 3,697 participants
Start Date 2022-11-02
Est. Completion 2024-03-11
Abbott Point of Care

8 total trials

What the finished NCT05629572 record still lists

NCT05629572 is an observational study that tracks outcomes without assigning an intervention. Its 3,697 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity is the first listed.

NCT05629572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05629572 about?

NCT05629572 is a clinical study titled "Abbott i-STAT High Sensitivity Troponin I Study". 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 (...

What is the current status of trial NCT05629572?

This trial is currently completed. The enrollment target is 3,697 participants. The study started on 2022-11-02. Estimated completion is 2024-03-11.

What interventions are being tested in trial NCT05629572?

The interventions under investigation include: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05629572?

This trial is sponsored by Abbott Point of Care, which has 8 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05629572, the US trial registry maintained by the National Library of Medicine. NCT05629572 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.