<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/NCT03009266</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00016794</org_study_id>
    <nct_id>NCT03009266</nct_id>
  </id_info>
  <brief_title>Ischemic Memory Imaging With Myocardial Contrast Echocardiography</brief_title>
  <official_title>Ischemic Memory Imaging With MCE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of this study is to determine whether non-invasive imaging with myocardial&#xD;
      contrast echocardiography using can provide information on the presence and spatial extent of&#xD;
      recent myocardial ischemia by non-invasive echocardiographic imaging.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose optimization</measure>
    <time_frame>3 months</time_frame>
    <description>Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection of Ischemia</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>Normal controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal controls who will undergo dose-ranging studies to determine the optimal dose of phosphatidylserine-containing microbubbles that does not produce delayed myocardial opacification on myocardial contrast echocardiography (MCE).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with ACS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with ACS who have undergone primary percutaneous intervention in whom MCE with phosphatidylserine-containing microbubbles will be performed to determine whether the risk area can be detected and spatially defined.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sonazoid</intervention_name>
    <description>Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid</description>
    <arm_group_label>Normal controls</arm_group_label>
    <arm_group_label>Patients with ACS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        NORMAL CONTROL GROUP&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal control individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiovascular disease (coronary artery disease, MI, peripheral artery&#xD;
             disease)&#xD;
&#xD;
          -  allergy to eggs or ultrasound contrast agents&#xD;
&#xD;
          -  known or detected right to left shunt&#xD;
&#xD;
          -  presence of a wall motion abnormality&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
        ACS GROUP&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of acute coronary syndrome with either unstable angina or&#xD;
             non-ST-elevation MI&#xD;
&#xD;
          -  Referred for primary percutaneous intervention&#xD;
&#xD;
          -  At least 1 high risk features (ST changes, positive troponin, wall motion abnormality)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to eggs or ultrasound contrast agents&#xD;
&#xD;
          -  hemodynamic instability or shock&#xD;
&#xD;
          -  known or detected right to left shunt&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  multivessel CAD requiring multivessel PCI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jonathan R Lindner, MD</last_name>
    <phone>5034949191</phone>
    <email>lindnerj@ohsu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>OHSU</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan R Lindner, MD</last_name>
      <phone>503-494-8750</phone>
      <email>lindnerj@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Jonathan R Lindner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brian Davidson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Jonathan R. Lindner, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03009266
org study id: IRB00016794
nct id: NCT03009266
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The overall aim of this study is to determine whether non-invasive imaging with myocardial
      contrast echocardiography using can provide information on the presence and spatial extent of
      recent myocardial ischemia by non-invasive echocardiographic imaging.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Dose optimization
time frame: 3 months
description: Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention
measure: Detection of Ischemia
time frame: 1 year
arm group label: Normal controls
arm group type: Experimental
description: Normal controls who will undergo dose-ranging studies to determine the optimal dose of phosphatidylserine-containing microbubbles that does not produce delayed myocardial opacification on myocardial contrast echocardiography (MCE).
arm group label: Patients with ACS
arm group type: Experimental
description: Subjects with ACS who have undergone primary percutaneous intervention in whom MCE with phosphatidylserine-containing microbubbles will be performed to determine whether the risk area can be detected and spatially defined.
intervention type: Drug
intervention name: Sonazoid
description: Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid
arm group label: Normal controls
arm group label: Patients with ACS
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan R Lindner, MD
phone: 5034949191
email: lindnerj@ohsu.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Jonathan R. Lindner, MD
investigator title: Professor
mesh term: Myocardial Ischemia
mesh term: Ischemia
sharing ipd: No