Evaluation of a New Cardiac Biomarker Assay

Last updated: March 4, 2015
Sponsor: Abbott Diagnostics Division
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Chest Pain

Heart Defect

Treatment

N/A

Clinical Study ID

NCT01608100
7B5-02-10A01-03
  • Ages > 18
  • All Genders

Study Summary

The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • presenting to the Emergency Department with symptoms consistent with or suggestive ofAcute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptomsconsistent with myocardial ischemia) up to 6 hours prior to initial evaluation.

  • an Electrocardiogram (ECG) result within 2 hours of presentation for observation ofAcute Coronary Syndrome (ACS).

  • greater than 18 years of age.

  • not known to be pregnant.

  • agreement to the follow-up required by the study.

Exclusion

Exclusion Criteria:

  • prior participation in this study.

  • require dialysis for end stage renal disease.

  • history of a previous heart transplant.

  • coexisting disorder associated with limited life expectancy.

  • currently participating in another investigational device or drug study.

Study Design

Total Participants: 1101
Study Start date:
June 01, 2012
Estimated Completion Date:
September 30, 2014

Study Description

The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction.

All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.

Connect with a study center

  • Chandler Regional Medical Center

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Stanford University School of Emergency Medicine

    Palo Alto, California 94304
    United States

    Site Not Available

  • Nationwide Laboratory Services

    Fort Lauderdale, Florida 33309
    United States

    Site Not Available

  • John T Mather Memorial Hospital

    Port Jefferson, New York 11777
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pennsylvania State University- Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104-4283
    United States

    Site Not Available

  • Hospital Physicians in Clinical Research

    Austin, Texas 78752
    United States

    Site Not Available

  • Hospital Physicians in Clinical Research

    Bryan, Texas 77802
    United States

    Site Not Available

  • Dept of Emergency Medicine University of Virginia

    Charlottesville, Virginia 22908-2877
    United States

    Site Not Available

  • St Joseph Hospital

    Bellingham, Washington 98225
    United States

    Site Not Available

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