VITROS Immunodiagnostic Products hs Troponin I

September 14, 2020 updated by: Ortho-Clinical Diagnostics, Inc.
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.

Study Overview

Status

Unknown

Conditions

Detailed 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 Type

Observational

Enrollment (Anticipated)

1630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Drug Research and Analysis Corp
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Detroit Receiving Hospital
      • Royal Oak, Michigan, United States, 48073
        • Beaumont
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin County Medical Center/Minneapolis Medical Research Foundation
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Science University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center El Paso
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital / Baylor College of Medicine/Harris Health System
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Inova Alexandria Hospital
      • Richmond, Virginia, United States, 29298
        • Virginia Commonwealth University Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin and Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS).

Description

Inclusion Criteria:

  1. Subject must be ≥22 years of age at the time of consent.
  2. Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
  3. Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
  4. Subject willing and able to provide informed consent.

Exclusion Criteria:

  1. Subject is unable to comply with the study requirements.
  2. Any samples which were not obtained under IRB approved protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the VITROS hs Troponin I test
Time Frame: VITROS hs Troponin I value at baseline
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
VITROS hs Troponin I value at baseline
Sensitivity and specificity of the VITROS hs Troponin I test
Time Frame: VITROS hs Troponin I value > 1 hour and up to 3 hours
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
VITROS hs Troponin I value > 1 hour and up to 3 hours
Sensitivity and specificity of the VITROS hs Troponin I test
Time Frame: VITROS hs Troponin I value at > 3 hours and up to 6 hours
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
VITROS hs Troponin I value at > 3 hours and up to 6 hours
Sensitivity and specificity of the VITROS hs Troponin I test
Time Frame: VITROS hs Troponin I value at > 6 hours and up to 9 hours
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
VITROS hs Troponin I value at > 6 hours and up to 9 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk stratification of subjects
Time Frame: Up to 12 months after last enrollment
Assess the use of cardiac Troponin I measurement in the risk stratification of subjects.
Up to 12 months after last enrollment
Rule in and rule out myocardial infarction (MI)
Time Frame: VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)
Evaluate the VITROS hs Troponin I test to rule in and rule out MI.
VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ortho-Clinical Diagnostics, Inc.

Investigators

  • Principal Investigator: Fred Apple, PhD, Hennepin Healthcare Research Institute
  • Principal Investigator: Richard Nowak, MD, Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2018

Primary Completion (Actual)

May 30, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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