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VITROS Immunodiagnostic Products hs Troponin I

Sponsor
Ortho-Clinical Diagnostics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03581578
Collaborator
(none)
1,630
Enrollment
24
Locations
35.8
Anticipated Duration (Months)
67.9
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1630 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    VITROS Immunodiagnostic Products hs Troponin I
    Actual Study Start Date :
    Jun 7, 2018
    Actual Primary Completion Date :
    May 30, 2020
    Anticipated Study Completion Date :
    Jun 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of the VITROS hs Troponin I test [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).

    2. Sensitivity and specificity of the VITROS hs Troponin I test [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).

    3. Sensitivity and specificity of the VITROS hs Troponin I test [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).

    4. Sensitivity and specificity of the VITROS hs Troponin I test [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).

    Secondary Outcome Measures

    1. Risk stratification of subjects [Up to 12 months after last enrollment]

      Assess the use of cardiac Troponin I measurement in the risk stratification of subjects.

    2. Rule in and rule out myocardial infarction (MI) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Drug Research and Analysis Corp Montgomery Alabama United States 36106
    2 Chandler Regional Medical Center Chandler Arizona United States 85224
    3 Yale New Haven Hospital New Haven Connecticut United States 06519
    4 University of Kansas Medical Center Kansas City Kansas United States 66160
    5 University of Maryland Baltimore Maryland United States 21201
    6 Mass General Hospital Boston Massachusetts United States 02114
    7 Wayne State University/Detroit Receiving Hospital Detroit Michigan United States 48201
    8 Henry Ford Health System Detroit Michigan United States 48202
    9 Beaumont Royal Oak Michigan United States 48073
    10 Hennepin County Medical Center/Minneapolis Medical Research Foundation Minneapolis Minnesota United States 55404
    11 Cooper University Hospital Camden New Jersey United States 08103
    12 Stony Brook University Hospital Stony Brook New York United States 11794
    13 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    14 University of Cincinnati Cincinnati Ohio United States 45267
    15 Oregon Health Science University Hospital Portland Oregon United States 97239
    16 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    17 Medical University of South Carolina Charleston South Carolina United States 29425
    18 UT Southwestern Medical Center Dallas Texas United States 75390
    19 Texas Tech University Health Sciences Center El Paso El Paso Texas United States 79905
    20 Ben Taub General Hospital / Baylor College of Medicine/Harris Health System Houston Texas United States 77030
    21 INOVA Alexandria Hospital Alexandria Virginia United States 22304
    22 Virginia Commonwealth University Medical Center Richmond Virginia United States 29298
    23 Charleston Area Medical Center Charleston West Virginia United States 25304
    24 Medical College of Wisconsin and Froedtert Hospital Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Ortho-Clinical Diagnostics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ortho-Clinical Diagnostics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03581578
    Other Study ID Numbers:
    • 16-002
    First Posted:
    Jul 10, 2018
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Ortho-Clinical Diagnostics, Inc.
    Troponin
    Additional relevant MeSH terms:
    Myocardial Infarction
    Acute Coronary Syndrome
    Infarction

    Study Results

    No Results Posted as of Sep 16, 2020