VITROS Immunodiagnostic Products hs Troponin I

Status Active, not recruiting

Clinical Trial Summary

The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.

Clinical Trial Description

A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study.

Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis.

Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03581578
Study type	Observational
Source	Ortho-Clinical Diagnostics, Inc.
Contact
Status	Active, not recruiting
Phase
Start date	June 7, 2018
Completion date	June 2021

View Details

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