<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/NCT02234336</url>
  </required_header>
  <id_info>
    <org_study_id>14-004757</org_study_id>
    <nct_id>NCT02234336</nct_id>
  </id_info>
  <brief_title>Assessment of Wall Thickness in Hypertrophic Cardiomyopathy</brief_title>
  <official_title>Assessment of Wall Thickness in Hypertrophic Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and&#xD;
      prognostic importance given its known association with sudden cardiac death. However, data&#xD;
      regarding comparison of imaging modalities for this key measurement is lacking. This study&#xD;
      seeks to compare assessment of maximum wall thickness between clinically indicated&#xD;
      echocardiography (with and without contrast) and clinically indicated cardiac magnetic&#xD;
      resonance imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients receiving clinically indicated echocardiograms and cardiac magnetic resonance&#xD;
      imaging at Mayo Clinic will be eligible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 25, 2017</completion_date>
  <primary_completion_date type="Actual">July 25, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular Wall Thickness</measure>
    <time_frame>approximately 1 week after enrollment</time_frame>
    <description>All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>Subjects with HCM</arm_group_label>
    <description>All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Noncontrast echocardiography</intervention_name>
    <arm_group_label>Subjects with HCM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Contrast Echocardiography</intervention_name>
    <arm_group_label>Subjects with HCM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac magnetic resonance imaging</intervention_name>
    <arm_group_label>Subjects with HCM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with hypertrophic cardiomyopathy (HCM)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinically and echocardiographically defined hypertrophic cardiomyopathy.&#xD;
&#xD;
          2. Clinically indicated transthoracic echocardiography as part of the medical evaluation.&#xD;
&#xD;
          3. No contradiction to administration of ultrasonic echocardiography contrast.&#xD;
&#xD;
          4. Planned clinically indicated cardiac magnetic resonance imaging as part of medical&#xD;
             evaluation.&#xD;
&#xD;
          5. No contraindication to cardiac magnetic resonance imaging (such as cochlear implants,&#xD;
             central nervous system aneurysm clips and other implanted medical devices).&#xD;
&#xD;
          6. Age 18 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Insufficient image quality for determination of maximal wall thickness.&#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>Patricia Pellikka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Patricia A. Pellikka</investigator_full_name>
    <investigator_title>Professor of Medicine, College of Medicine</investigator_title>
  </responsible_party>
  <keyword>Echocardiography</keyword>
  <keyword>hypertrophic cardiomyopathy</keyword>
  <keyword>cardiomyopathy</keyword>
  <keyword>magnetic resonance imaging</keyword>
  <keyword>contrast</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</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/NCT02234336
org study id: 14-004757
nct id: NCT02234336
lead sponsor: 
collaborator: 
has dmc: No
Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and
      prognostic importance given its known association with sudden cardiac death. However, data
      regarding comparison of imaging modalities for this key measurement is lacking. This study
      seeks to compare assessment of maximum wall thickness between clinically indicated
      echocardiography (with and without contrast) and clinically indicated cardiac magnetic
      resonance imaging.
Patients receiving clinically indicated echocardiograms and cardiac magnetic resonance
      imaging at Mayo Clinic will be eligible.
observational model: Cohort
time perspective: Prospective
measure: Left Ventricular Wall Thickness
time frame: approximately 1 week after enrollment
description: All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.
arm group label: Subjects with HCM
description: All subjects will undergo noncontrast echocardiography, contrast echocardiography and cardiac MRI.
intervention type: Procedure
intervention name: Noncontrast echocardiography
arm group label: Subjects with HCM
intervention type: Procedure
intervention name: Contrast Echocardiography
arm group label: Subjects with HCM
intervention type: Procedure
intervention name: Cardiac magnetic resonance imaging
arm group label: Subjects with HCM
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Pellikka, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Patricia A. Pellikka
investigator title: Professor of Medicine, College of Medicine
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy