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Carotid Ultrasound in the Evaluation of Heart Failure (CUE-HF)

Primary Purpose

Coronary Artery Disease, Cardiomyopathy, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carotid ultrasound
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • LVEF 40% or less

Exclusion Criteria:

  • Prior diagnosis of coronary or carotid obstructive atherosclerosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    LV systolic dysfunction

    Arm Description

    Diagnostic Testing

    Outcomes

    Primary Outcome Measures

    Diagnostic accuracy for severe CAD

    Secondary Outcome Measures

    Diagnostic accuracy for significant CAD

    Full Information

    First Posted
    December 17, 2008
    Last Updated
    April 5, 2016
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00810550
    Brief Title
    Carotid Ultrasound in the Evaluation of Heart Failure
    Acronym
    CUE-HF
    Official Title
    Carotid Ultrasound in the Evaluation of Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.
    Detailed Description
    Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Cardiomyopathy, Heart Failure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LV systolic dysfunction
    Arm Type
    Other
    Arm Description
    Diagnostic Testing
    Intervention Type
    Other
    Intervention Name(s)
    Carotid ultrasound
    Intervention Description
    Measurement of intima-media thickness
    Primary Outcome Measure Information:
    Title
    Diagnostic accuracy for severe CAD
    Time Frame
    1 Day
    Secondary Outcome Measure Information:
    Title
    Diagnostic accuracy for significant CAD
    Time Frame
    1 Day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: LVEF 40% or less Exclusion Criteria: Prior diagnosis of coronary or carotid obstructive atherosclerosis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20569720
    Citation
    Reynolds HR, Steckman DA, Tunick PA, Kronzon I, Lobach I, Rosenzweig BP. Normal intima-media thickness on carotid ultrasound reliably excludes an ischemic cause of cardiomyopathy. Am Heart J. 2010 Jun;159(6):1059-66. doi: 10.1016/j.ahj.2010.03.026.
    Results Reference
    derived

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    Carotid Ultrasound in the Evaluation of Heart Failure

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