<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/NCT01665300</url>
  </required_header>
  <id_info>
    <org_study_id>H1106-026-365</org_study_id>
    <nct_id>NCT01665300</nct_id>
  </id_info>
  <brief_title>Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity</brief_title>
  <official_title>Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type&#xD;
      2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment&#xD;
      has been mandated to detect myocardial dysfunction because of the risk of heart failure with&#xD;
      this treatment. Myocardial deformation imaging is a sensitive means of detecting LV&#xD;
      dysfunction, but this technique has not been evaluated in patients treated with trastuzumab.&#xD;
      The aim of this study was to investigate whether changes in tissue deformation, assessed by&#xD;
      myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than&#xD;
      conventional echocardiographic measures in patients treated with trastuzumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will prospectively evaluate whether changes in tissue deformation, assessed&#xD;
      by myocardial strain and strain rate (SR) and identify possibility of early detection of LV&#xD;
      dysfunction in patients treated with trastuzumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">December 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>LV systolic dysfunction</measure>
    <time_frame>3-month F/U</time_frame>
    <description>LV systolic dysfunction was defined as following;&#xD;
An EF unit drop of ≥10% from the baseline available echocardiogram or&#xD;
Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LV systolic dysfunction</measure>
    <time_frame>6,9, and 12-month F/U</time_frame>
    <description>LV systolic dysfunction was defined as following;&#xD;
An EF unit drop of ≥10% from the baseline available echocardiogram or&#xD;
Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram</description>
  </secondary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Left Ventricular Function Systolic Dysfunction</condition>
  <condition>Cardiotoxicity</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      genetic susceptibility for HER2(+)cardiotoxicity&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators evaluated serial echocardiograms (baseline, 3, 6, 9, and 12 months)from&#xD;
        120 consecutive female patients receiving trastuzumab as part of their treatment for either&#xD;
        early or advanced breast cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HER2(+) breast cancer, anticipating Trastuzumab therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to informed consent&#xD;
&#xD;
          -  Congenital heart disease&#xD;
&#xD;
          -  Significant arrhythmia in EKG&#xD;
&#xD;
          -  Regional wall motion abnormality (+) in echocardiography&#xD;
&#xD;
          -  Poor sonic window&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyung-Kwan Kim, M.D., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>December 13, 2011</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>April 26, 2014</last_update_submitted>
  <last_update_submitted_qc>April 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hyung-Kwan Kim</investigator_full_name>
    <investigator_title>MD, PhD, Assistant Professor, Seoul National University Cardiovascular center</investigator_title>
  </responsible_party>
  <keyword>myocardial deformation imaging</keyword>
  <keyword>Trastuzumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiotoxicity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01665300
org study id: H1106-026-365
nct id: NCT01665300
lead sponsor: 
has dmc: No
Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type
      2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment
      has been mandated to detect myocardial dysfunction because of the risk of heart failure with
      this treatment. Myocardial deformation imaging is a sensitive means of detecting LV
      dysfunction, but this technique has not been evaluated in patients treated with trastuzumab.
      The aim of this study was to investigate whether changes in tissue deformation, assessed by
      myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than
      conventional echocardiographic measures in patients treated with trastuzumab.
The investigators will prospectively evaluate whether changes in tissue deformation, assessed
      by myocardial strain and strain rate (SR) and identify possibility of early detection of LV
      dysfunction in patients treated with trastuzumab.
observational model: Case-Only
time perspective: Prospective
measure: LV systolic dysfunction
time frame: 3-month F/U
description: LV systolic dysfunction was defined as following;
An EF unit drop of ≥10% from the baseline available echocardiogram or
Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram
measure: LV systolic dysfunction
time frame: 6,9, and 12-month F/U
description: LV systolic dysfunction was defined as following;
An EF unit drop of ≥10% from the baseline available echocardiogram or
Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram
genetic susceptibility for HER2(+)cardiotoxicity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hyung-Kwan Kim, M.D., PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hyung-Kwan Kim
investigator title: MD, PhD, Assistant Professor, Seoul National University Cardiovascular center
mesh term: Cardiotoxicity