search
Back to results

Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles (MI)

Primary Purpose

Cardiac Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high MI impulses
low MI impulses
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiac Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age 19 years or older Exclusion Criteria: severe aortic valve stenosis pregnant or lactating women atrial fibrillation very poor image quality despite contrast use. unstable cardiac condition such as cardiogenic shock. allergy to UEA presence of right to left or bidirectional shunts. Patients on mechanical circulatory support.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    high MI

    low MI

    Arm Description

    patients receiving high MI impulses

    patients receiving low MI impulses

    Outcomes

    Primary Outcome Measures

    Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
    Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI

    Secondary Outcome Measures

    stroke volume
    The volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction

    Full Information

    First Posted
    January 17, 2023
    Last Updated
    October 3, 2023
    Sponsor
    University of Nebraska
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05700032
    Brief Title
    Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles
    Acronym
    MI
    Official Title
    The Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume in Patients Receiving Intravenous Microbubbles
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to clinical service demand study was withdrawn and not activated
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    February 15, 2021 (Actual)
    Study Completion Date
    February 15, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will investigate whether applying high mechanical index (MI) impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent (UEA) microbubble infusion will result in subclinical improvement in left ventricle systolic function.
    Detailed Description
    The purpose of this study is to investigate whether applying high MI impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent(UEA) microbubble infusion will result in subclinical improvement in LV systolic function detected by left ventricular outflow tract velocity time integral (LVOT VTI).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high MI
    Arm Type
    Experimental
    Arm Description
    patients receiving high MI impulses
    Arm Title
    low MI
    Arm Type
    Active Comparator
    Arm Description
    patients receiving low MI impulses
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    high MI impulses
    Intervention Description
    patients will receive intermittent high MI impulses(>1.0) in addition to low MI imaging. LVOT VTI will be measured at different times per protocol.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    low MI impulses
    Intervention Description
    patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.
    Primary Outcome Measure Information:
    Title
    Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
    Description
    Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
    Time Frame
    10 minutes
    Secondary Outcome Measure Information:
    Title
    stroke volume
    Description
    The volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age 19 years or older Exclusion Criteria: severe aortic valve stenosis pregnant or lactating women atrial fibrillation very poor image quality despite contrast use. unstable cardiac condition such as cardiogenic shock. allergy to UEA presence of right to left or bidirectional shunts. Patients on mechanical circulatory support.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Swethika Harini Sundaravel, MD
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles

    We'll reach out to this number within 24 hrs