<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01734174</url>
  </required_header>
  <id_info>
    <org_study_id>1207012636</org_study_id>
    <nct_id>NCT01734174</nct_id>
  </id_info>
  <brief_title>Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography</brief_title>
  <official_title>Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Echocardiography is an ultrasound-based imaging technique which can be performed through the&#xD;
      esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are&#xD;
      performed routinely as a monitoring and diagnostic tool at different times in the course of&#xD;
      one cardiac surgery. The purpose of the study is to compare these two methods of&#xD;
      echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely&#xD;
      performed simultaneously. The study will also compare the echocardiography data to a third&#xD;
      technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to obtain 3D TTE to complete study procedure.&#xD;
  </why_stopped>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>General heart function (Left ventricular volume and ejection fraction)</measure>
    <time_frame>During cardiac surgery</time_frame>
    <description>Left ventricular volume will be assessed by 3-dimensional transesophageal echocardiography (3D TEE) and compared to data from 3-dimensional transthoracic echocardiography (3D TTE). 3D measurements will be compared to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, this assessment will be compared to a third method of quantification of cardiac function via a pulmonary artery catheter.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>3D Transesophageal and Transthoracic Echocardiogram</condition>
  <arm_group>
    <arm_group_label>cardiac patients</arm_group_label>
    <description>Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries will be recruited for this study to validate measurements of left ventricular volume and ejection fraction (a quantitative measure of general heart function) as assessed by 3-dimensional transesophageal echocardiography (3D TEE) as compared to 3-dimensional transthoracic echocardiography (3D TTE). Secondarily, we will also compare the 3D TEE assessment to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, we will compare this assessment to a third method of quantification of cardiac function via a pulmonary artery catheter using thermodilution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transesophageal echocardiography (TEE)</intervention_name>
    <description>Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.</description>
    <arm_group_label>cardiac patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thermodilution</intervention_name>
    <description>A catheter is positioned in the pulmonary artery and the heart function is assessed via thermodilution which involves measuring the temperature of blood when a known volume of fluid is injected through the catheter to determine how quickly blood is carried from one part of the catheter to the other.</description>
    <arm_group_label>cardiac patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transthoracic echocardiography (TTE)</intervention_name>
    <description>Echocardiography is an ultrasound-based imaging technique which can be performed through the chest wall and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.</description>
    <arm_group_label>cardiac patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having elective coronary artery bypass grafting surgery, valve repair or&#xD;
        replacement surgery, aortic repair or replacement surgery, or any combination of these&#xD;
        surgeries.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective coronary artery bypass grafting surgery, valve repair or replacement surgery,&#xD;
             aortic repair or replacement surgery, or any combination of these surgeries.&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion criteria for thermodilution assessment are as follows:&#xD;
&#xD;
          -  Moderate to severe tricuspid regurgitation&#xD;
&#xD;
          -  Contraindications to pulmonary artery catheter placement based on the American Society&#xD;
             of Anesthesiologist's 2003 Practice Guidelines for Pulmonary Artery Catheterization.&#xD;
&#xD;
        Exclusion criteria for performance of TEE:&#xD;
&#xD;
          -  Contraindications to the performance of TEE based on the Journal of the American&#xD;
             Society of Echocardiologists' 2011 recommendations and the American Society of&#xD;
             Anesthesiologist Guidelines for Performance of Perioperative Transesophageal&#xD;
             Echocardiography.&#xD;
&#xD;
          -  Any degree of mitral regurgitation or aortic insufficiency above trace.&#xD;
&#xD;
        Exclusion criteria for performance of TTE, both 3D and 2D:&#xD;
&#xD;
          -  Qualified echocardiographer absent or unavailable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meghann Fitzgerald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transesophageal and transthoracic echocardiogram</keyword>
  <keyword>thermodilution</keyword>
  <keyword>left ventricular volume</keyword>
  <keyword>ejection volume</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01734174
org study id: 1207012636
nct id: NCT01734174
lead sponsor: 
has dmc: No
Echocardiography is an ultrasound-based imaging technique which can be performed through the
      esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are
      performed routinely as a monitoring and diagnostic tool at different times in the course of
      one cardiac surgery. The purpose of the study is to compare these two methods of
      echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely
      performed simultaneously. The study will also compare the echocardiography data to a third
      technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.
observational model: Case-Only
time perspective: Prospective
measure: General heart function (Left ventricular volume and ejection fraction)
time frame: During cardiac surgery
description: Left ventricular volume will be assessed by 3-dimensional transesophageal echocardiography (3D TEE) and compared to data from 3-dimensional transthoracic echocardiography (3D TTE). 3D measurements will be compared to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, this assessment will be compared to a third method of quantification of cardiac function via a pulmonary artery catheter.
arm group label: cardiac patients
description: Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries will be recruited for this study to validate measurements of left ventricular volume and ejection fraction (a quantitative measure of general heart function) as assessed by 3-dimensional transesophageal echocardiography (3D TEE) as compared to 3-dimensional transthoracic echocardiography (3D TTE). Secondarily, we will also compare the 3D TEE assessment to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, we will compare this assessment to a third method of quantification of cardiac function via a pulmonary artery catheter using thermodilution.
intervention type: Procedure
intervention name: transesophageal echocardiography (TEE)
description: Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.
arm group label: cardiac patients
intervention type: Procedure
intervention name: thermodilution
description: A catheter is positioned in the pulmonary artery and the heart function is assessed via thermodilution which involves measuring the temperature of blood when a known volume of fluid is injected through the catheter to determine how quickly blood is carried from one part of the catheter to the other.
arm group label: cardiac patients
intervention type: Procedure
intervention name: transthoracic echocardiography (TTE)
description: Echocardiography is an ultrasound-based imaging technique which can be performed through the chest wall and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.
arm group label: cardiac patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Meghann Fitzgerald, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor