<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/NCT01721447</url>
  </required_header>
  <id_info>
    <org_study_id>11-OPT-018 GE</org_study_id>
    <nct_id>NCT01721447</nct_id>
  </id_info>
  <brief_title>Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage</brief_title>
  <acronym>DOLOP</acronym>
  <official_title>The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators intend to determine if using Optison echocardiography contrast increases&#xD;
      sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal&#xD;
      echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo&#xD;
      contrast.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has&#xD;
      a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke&#xD;
      and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can&#xD;
      lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation)&#xD;
      and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin&#xD;
      anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial&#xD;
      fibrillation ablation procedures at a time when there is higher risk of subsequent embolic&#xD;
      stroke.&#xD;
&#xD;
      Several of the patients with atrial fibrillation require transesophageal echocardiography&#xD;
      (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is&#xD;
      opportunity to enroll most of these patients in our proposed study. There has been&#xD;
      essentially no work published about the use of echo contrast materials in TEE (other than&#xD;
      agitated saline), particularly the use of Optison. Thus, the investigators will be exploring&#xD;
      a new field in echocardiography and echo contrast.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Confidence in Assessment of Left Atrial Appendage Thrombus</measure>
    <time_frame>One Transesophageal Echocardiography, up to 1 hour</time_frame>
    <description>Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage</measure>
    <time_frame>One transesophageal echocardiography, up to 1 hour</time_frame>
    <description>Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Echo arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Optison echocardiography contrast agent</intervention_name>
    <description>Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.</description>
    <arm_group_label>Echo arm</arm_group_label>
    <other_name>Perflutren Protein-Type A microspheres</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years old&#xD;
&#xD;
          -  Cognitively sound and able to provide informed consent&#xD;
&#xD;
          -  Indicated for TEE as a standard clinical procedure for evaluation of cardiac health&#xD;
             status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated for Optison administration&#xD;
&#xD;
          -  Known right-to-left or bi-directional cardiac shunts&#xD;
&#xD;
          -  Hypersensitivity to perflutren, blood, blood products or albumen&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Removal of Left Atrial Appendage&#xD;
&#xD;
          -  Not able to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brent D Wilson, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wei K, Mulvagh SL, Carson L, Davidoff R, Gabriel R, Grimm RA, Wilson S, Fane L, Herzog CA, Zoghbi WA, Taylor R, Farrar M, Chaudhry FA, Porter TR, Irani W, Lang RM. The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. J Am Soc Echocardiogr. 2008 Nov;21(11):1202-6. doi: 10.1016/j.echo.2008.07.019. Epub 2008 Oct 10.</citation>
    <PMID>18848430</PMID>
  </reference>
  <reference>
    <citation>Clark LN, Dittrich HC. Cardiac imaging using Optison. Am J Cardiol. 2000 Aug 17;86(4A):14G-18G. doi: 10.1016/s0002-9149(00)00984-x.</citation>
    <PMID>10997346</PMID>
  </reference>
  <reference>
    <citation>Bhatia VK, Senior R. Contrast echocardiography: evidence for clinical use. J Am Soc Echocardiogr. 2008 May;21(5):409-16. doi: 10.1016/j.echo.2008.01.018. Epub 2008 Mar 10.</citation>
    <PMID>18329848</PMID>
  </reference>
  <reference>
    <citation>Bednarz JE, Spencer KT, Weinert L, Sugeng L, Mor-Avi V, Lang RM. Identification of cardiac masses and abnormal blood flow patterns with harmonic power Doppler contrast echocardiography. J Am Soc Echocardiogr. 1999 Oct;12(10):871-5. doi: 10.1016/s0894-7317(99)70195-1.</citation>
    <PMID>10511659</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>May 15, 2019</results_first_submitted>
  <results_first_submitted_qc>May 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2019</results_first_posted>
  <last_update_submitted>August 17, 2019</last_update_submitted>
  <last_update_submitted_qc>August 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Brent Wilson</investigator_full_name>
    <investigator_title>Assistant Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>stroke</keyword>
  <keyword>TEE</keyword>
  <keyword>Left atrial thrombus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT01721447/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Echo Arm</title>
          <description>Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent&#xD;
Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Echo Arm</title>
          <description>Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent&#xD;
Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.9" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Confidence in Assessment of Left Atrial Appendage Thrombus</title>
        <description>Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.</description>
        <time_frame>One Transesophageal Echocardiography, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pre-Contrast</title>
            <description>Standard trans-esophageal echocardiography imaging prior to injection of Optison contrast</description>
          </group>
          <group group_id="O2">
            <title>Post-Contrast</title>
            <description>Trans-esophageal echocardiography imaging following injection of Optison contrast</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Confidence in Assessment of Left Atrial Appendage Thrombus</title>
          <description>Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.</description>
          <units>Percentage of Confidence</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="12.5"/>
                    <measurement group_id="O2" value="95" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage</title>
        <description>Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent</description>
        <time_frame>One transesophageal echocardiography, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pre-Contrast</title>
            <description>Standard trans-esophageal echocardiography imaging prior to injection of Optison contrast</description>
          </group>
          <group group_id="O2">
            <title>Post-Contrast</title>
            <description>Trans-esophageal echocardiography imaging following injection of Optison contrast</description>
          </group>
        </group_list>
        <measure>
          <title>Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage</title>
          <description>Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent</description>
          <units>Percentage of Agreement</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 Months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Echo Arm</title>
          <description>Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent&#xD;
Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient Ischemic Attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Brent Wilson</name_or_title>
      <organization>University of Utah Division of Cardiovascular Medicine</organization>
      <phone>801-585-2341</phone>
      <email>brent.wilson@hsc.utah.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01721447
org study id: 11-OPT-018 GE
nct id: NCT01721447
lead sponsor: 
has dmc: Yes
The investigators intend to determine if using Optison echocardiography contrast increases
      sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal
      echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo
      contrast.
Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has
      a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke
      and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can
      lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation)
      and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin
      anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial
      fibrillation ablation procedures at a time when there is higher risk of subsequent embolic
      stroke.

      Several of the patients with atrial fibrillation require transesophageal echocardiography
      (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is
      opportunity to enroll most of these patients in our proposed study. There has been
      essentially no work published about the use of echo contrast materials in TEE (other than
      agitated saline), particularly the use of Optison. Thus, the investigators will be exploring
      a new field in echocardiography and echo contrast.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percent Confidence in Assessment of Left Atrial Appendage Thrombus
time frame: One Transesophageal Echocardiography, up to 1 hour
description: Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.
measure: Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage
time frame: One transesophageal echocardiography, up to 1 hour
description: Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent
arm group label: Echo arm
arm group type: Experimental
description: Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent
intervention type: Drug
intervention name: Optison echocardiography contrast agent
description: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
arm group label: Echo arm
other name: Perflutren Protein-Type A microspheres
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Brent D Wilson, MD, PHD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
citation: Wei K, Mulvagh SL, Carson L, Davidoff R, Gabriel R, Grimm RA, Wilson S, Fane L, Herzog CA, Zoghbi WA, Taylor R, Farrar M, Chaudhry FA, Porter TR, Irani W, Lang RM. The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. J Am Soc Echocardiogr. 2008 Nov;21(11):1202-6. doi: 10.1016/j.echo.2008.07.019. Epub 2008 Oct 10.
PMID: 18848430
citation: Clark LN, Dittrich HC. Cardiac imaging using Optison. Am J Cardiol. 2000 Aug 17;86(4A):14G-18G. doi: 10.1016/s0002-9149(00)00984-x.
PMID: 10997346
citation: Bhatia VK, Senior R. Contrast echocardiography: evidence for clinical use. J Am Soc Echocardiogr. 2008 May;21(5):409-16. doi: 10.1016/j.echo.2008.01.018. Epub 2008 Mar 10.
PMID: 18329848
citation: Bednarz JE, Spencer KT, Weinert L, Sugeng L, Mor-Avi V, Lang RM. Identification of cardiac masses and abnormal blood flow patterns with harmonic power Doppler contrast echocardiography. J Am Soc Echocardiogr. 1999 Oct;12(10):871-5. doi: 10.1016/s0894-7317(99)70195-1.
PMID: 10511659
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Brent Wilson
investigator title: Assistant Professor of Internal Medicine
mesh term: Atrial Fibrillation
mesh term: Thrombosis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 