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Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2D doppler echo with Definity solution
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Arterial Hypertension, Pulmonary Vascular Resistance, Right Heart Catheterization

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients scheduled to undergo right heart catheterization at the George Washington University Hospital

Exclusion Criteria:

  • Patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to Definity or hypersensitivity to perflutren

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    2D doppler echo with Definity solution

    Arm Description

    Study subjects will already be scheduled for right heart catheterization to diagnose pulmonary hypertension. Prior to the catheterization, each subject will have a 2D doppler echocardiogram with Definity solution as well.

    Outcomes

    Primary Outcome Measures

    Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution
    Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2013
    Last Updated
    January 3, 2014
    Sponsor
    George Washington University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02028299
    Brief Title
    Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography
    Official Title
    Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    George Washington University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    An echocardiogram using Definity contrast can provide the same information as the standard right heart catheterization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Arterial Hypertension
    Keywords
    Pulmonary Arterial Hypertension, Pulmonary Vascular Resistance, Right Heart Catheterization

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    2D doppler echo with Definity solution
    Arm Type
    Experimental
    Arm Description
    Study subjects will already be scheduled for right heart catheterization to diagnose pulmonary hypertension. Prior to the catheterization, each subject will have a 2D doppler echocardiogram with Definity solution as well.
    Intervention Type
    Procedure
    Intervention Name(s)
    2D doppler echo with Definity solution
    Other Intervention Name(s)
    Definity solution
    Intervention Description
    Correlate right heart catheterization results with results from 2D doppler echo with Definity Solution
    Primary Outcome Measure Information:
    Title
    Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution
    Description
    Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.
    Time Frame
    Two Years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients scheduled to undergo right heart catheterization at the George Washington University Hospital Exclusion Criteria: Patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to Definity or hypersensitivity to perflutren
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Choi, MD
    Organizational Affiliation
    Medical Faculty Associates, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography

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