MedTrace Logo

Abbott i-STAT High Sensitivity Troponin I Study

NCT05629572 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3697

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Abbott Point of Care

    lead INDUSTRY

Principal Investigators

  • Manish Gupta, MS, MBA · Abbott Point of Care

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2024-02-06
Completion
2024-03-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629572 on ClinicalTrials.gov