<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/NCT04439942</url>
  </required_header>
  <id_info>
    <org_study_id>PI2020_843_0047</org_study_id>
    <nct_id>NCT04439942</nct_id>
  </id_info>
  <brief_title>4D-flow MRI to Assess Left Ventricular Obstruction in Hypertrophic Cardiomyopathy</brief_title>
  <acronym>CMHFLUX</acronym>
  <official_title>4D Flow Cardiac MRI Velocity Mapping in Patients With Hypertrophic Cardiomyopathy: Assessment of the Severity of the Left Ventricular Obstruction and Comparison With Echocardiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated&#xD;
      prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the&#xD;
      presence and extent of left ventricular obstruction. To date, the only method allowing a&#xD;
      reliable assessment of the extent of left ventricular obstruction is Doppler&#xD;
      echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging&#xD;
      (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences&#xD;
      cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire&#xD;
      volume with the ability to simultaneously measure the outputs of all vessels within that&#xD;
      volume in a single sequence and might be able to quantify left ventricular obstruction.&#xD;
&#xD;
      The main objective of this study is to compare the quantification of left ventricular&#xD;
      obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">June 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 1, 2023</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>Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.</measure>
    <time_frame>day 1</time_frame>
    <description>Correlation coefficient assessment between the maximum gradient obtained by 4D flow</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast</measure>
    <time_frame>day 1</time_frame>
    <description>Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast</description>
  </secondary_outcome>
  <enrollment type="Actual">26</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <condition>Obstruction</condition>
  <condition>Echocardiography</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardiac magnetic resonance imaging (MRI)</intervention_name>
    <description>Cardiac MRI is a mandatory examination for Hypertrophic cardiomyopathy patients as it provides important information about the presence of fibrosis which is also directly associated with sudden cardiac death.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with Hypertrophic cardiomyopathy will undergo Doppler-echocardiography&#xD;
        followed promptly (within the same hour) by a complete cardiac MRI with the addition of a&#xD;
        4D Flow sequence (does not require the injection of a contrast agent and does not prolong&#xD;
        the duration of the examination).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Presence of a Hypertrophic cardiomyopathy (HCM)&#xD;
&#xD;
          -  Affiliation to a social security program&#xD;
&#xD;
          -  Ability of the subject to understand and express opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major obesity (&gt; 140 kg) not allowing the patient to enter the tunnel of the machine&#xD;
             whose diameter is less than 70cm,&#xD;
&#xD;
          -  Age &lt; 18,&#xD;
&#xD;
          -  Person under guardianship or curators,&#xD;
&#xD;
          -  Pregnant woman,&#xD;
&#xD;
          -  Allergy to gadolinium chelates,&#xD;
&#xD;
          -  Claustrophobia,&#xD;
&#xD;
          -  Any contraindications to MRI&#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>Cédric Renard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertrophic Cardiomyopathy</keyword>
  <keyword>4D-flow magnetic resonance imaging</keyword>
  <keyword>Obstruction</keyword>
  <keyword>maximal gradient</keyword>
  <keyword>echocardiography</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>
  <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/NCT04439942
org study id: PI2020_843_0047
nct id: NCT04439942
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated
      prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the
      presence and extent of left ventricular obstruction. To date, the only method allowing a
      reliable assessment of the extent of left ventricular obstruction is Doppler
      echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging
      (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences
      cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire
      volume with the ability to simultaneously measure the outputs of all vessels within that
      volume in a single sequence and might be able to quantify left ventricular obstruction.

      The main objective of this study is to compare the quantification of left ventricular
      obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.
observational model: Case-Only
time perspective: Prospective
measure: Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.
time frame: day 1
description: Correlation coefficient assessment between the maximum gradient obtained by 4D flow
measure: Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
time frame: day 1
description: Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
intervention type: Other
intervention name: cardiac magnetic resonance imaging (MRI)
description: Cardiac MRI is a mandatory examination for Hypertrophic cardiomyopathy patients as it provides important information about the presence of fibrosis which is also directly associated with sudden cardiac death.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cédric Renard, MD
role: Principal Investigator
affiliation: CHU Amiens
facility: 
country: France
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy
sharing ipd: No