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Assessing Myocardial Blood Flow and Blood Flow Reserve by Transoesophageal Echocardiography (TEE)

Primary Purpose

Coronary Artery Disease

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SonoVue
Optison
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, Coronary artery bypass graft surgery, SPECT, Adenosin

Eligibility Criteria

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

Inclusion Criteria: Part I: Patients with angiographically normal coronary vessels undergoing elective valve surgery or patients with coronary artery disease (CAD) who are planned for elective CABG surgery Part II: Patients with CAD who are planned for elective CABG surgery and who had SPECT including adenosine for hyperemia before surgery Exclusion Criteria: No consent Acute coronary syndrome Acute heart failure Left ventricular ejection fraction < 30% Pronounced pulmonary artery hypertension Known adverse reaction against Optison or SonoVue or their components Severe renal or hepatic insufficiency Severe obstructive lung disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    coronary bypass graft patency

    Secondary Outcome Measures

    long-term survival

    Full Information

    First Posted
    February 2, 2006
    Last Updated
    March 24, 2015
    Sponsor
    University Hospital, Basel, Switzerland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00286559
    Brief Title
    Assessing Myocardial Blood Flow and Blood Flow Reserve by Transoesophageal Echocardiography (TEE)
    Official Title
    Feasibility and Accuracy of Transoesophageal Harmonic Contrast Echocardiography in Assessing Myocardial Blood Flow and Blood Flow Reserve
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    echo contrast agents no longer allowed in CAD patients.
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2008 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Basel, Switzerland

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Until today it was not possible to reliably assess the function of a new bypass, i.e., to measure myocardial perfusion. Measuring intramyocardial blood flow directly after revascularisation would greatly improve the assessment of graft function. With transthoracic contrast echocardiography, myocardial perfusion can be reliably assessed, as it has been shown in numerous studies. In the first part of the study the investigators will clarify methodological aspects of contrast echocardiography. In the second part they will analyze the validity of contrast TEE in the operating room.
    Detailed Description
    Until today it was not possible to reliably assess the function of a new bypass, i.e., to measure myocardial perfusion. Measuring intramyocardial blood flow directly after revascularisation would greatly improve the assessment of graft function. With transthoracic contrast echocardiography myocardial perfusion can be reliably assessed, as it has been shown in numerous studies. As there is a new transoesophageal ultrasound probe on the market which allows contrast imaging, we would like to establish contrast echocardiography in the operating room in patients undergoing CABG surgery. Ultrasound contrast agents (e.g., SonoVue®, Optison®) consist of gas filled microspheres surrounded by a stabilizing coat. They are smaller than red blood cells and similar to blood in their rheological habit. The microspheres are injected into a peripheral or central vein. They pass lung circulation and disperse into the left heart, coronary arteries and body circulation. A few minutes after administration the low-soluble gas of the microspheres is exhaled. The interaction of the ultrasound beam with microspheres leads to oscillation of the microspheres and thereby amplification of the ultrasound signal. This technique allows enhancement of endocardial border but also visualization of myocardial perfusion and assessment of myocardial blood flow reserve. The latter requires measurement of myocardial perfusion a first time at rest and a second time during hyperemia with adenosine. The quotient of both gives myocardial flow reserve. This parameter is of paramount importance in cardiology to detect coronary artery stenosis and reduced coronary or myocardial flow reserve quantitatively. The contrast agents as well as adenosine (a natural purine nucleoside, which can be found in all cells of the body) have a good safety profile with harmless and transient side effects. Our patients will be under anesthesia and therefore feel none of those side effects. The study will be spread into two parts. In a first part we will clarify methodological aspects of contrast echocardiography: two different contrast agents and three different contrast imaging methods will be evaluated. One imaging method and one contrast agent will be chosen for the second part. In the second part we will analyze the validity of contrast TEE in the operating room. In addition correlation of changes in myocardial blood flow after coronary artery bypass graft (CABG) surgery and improvement in myocardial perfusion as well as global and regional function in follow-up SPECT (Single Photon Emission Computed Tomography) and transthoracic echocardiography, respectively will be evaluated. By means of these data we possibly will be able to predict success of revascularisation at the end of surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    Coronary artery disease, Coronary artery bypass graft surgery, SPECT, Adenosin

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SonoVue
    Intervention Type
    Drug
    Intervention Name(s)
    Optison
    Primary Outcome Measure Information:
    Title
    coronary bypass graft patency
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    long-term survival
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Part I: Patients with angiographically normal coronary vessels undergoing elective valve surgery or patients with coronary artery disease (CAD) who are planned for elective CABG surgery Part II: Patients with CAD who are planned for elective CABG surgery and who had SPECT including adenosine for hyperemia before surgery Exclusion Criteria: No consent Acute coronary syndrome Acute heart failure Left ventricular ejection fraction < 30% Pronounced pulmonary artery hypertension Known adverse reaction against Optison or SonoVue or their components Severe renal or hepatic insufficiency Severe obstructive lung disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manfred D Seeberger, Prof. Dr.
    Organizational Affiliation
    University Hospital, Basel, Switzerland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Assessing Myocardial Blood Flow and Blood Flow Reserve by Transoesophageal Echocardiography (TEE)

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