<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/NCT02980614</url>
  </required_header>
  <id_info>
    <org_study_id>PI2016_843_0026</org_study_id>
    <nct_id>NCT02980614</nct_id>
  </id_info>
  <brief_title>4D Velocity Mapping of the Heart in rTOF Patients</brief_title>
  <acronym>CARDIOFLUX</acronym>
  <official_title>Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume</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>
      MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its&#xD;
      branches inside the same sequence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its&#xD;
      branches inside the same sequence. The objective of the project is to compare the regurgitant&#xD;
      fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in&#xD;
      repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization&#xD;
      will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA&#xD;
      flow +RightPA flow ? ).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regurgitant fraction comparison</measure>
    <time_frame>Day 0</time_frame>
    <description>The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Right ventricular volume</measure>
    <time_frame>Day 0</time_frame>
    <description>The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary arteries flows</measure>
    <time_frame>Day 0</time_frame>
    <description>The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery (PA) tree (PA flow =LeftPA flow +RightPA flow ? ).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Tetralogy of Fallot</condition>
  <arm_group>
    <arm_group_label>Participants to 4D flow imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the standard clinical MR protocol, 2 added sequences:&#xD;
4D MR sequence in cine mode 4D velocity mapping sequence</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>4D flow imaging</intervention_name>
    <description>To compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery</description>
    <arm_group_label>Participants to 4D flow imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tetralogy of Fallot patients&#xD;
&#xD;
          -  referred for clinical MRI examination&#xD;
&#xD;
          -  ≥ 15 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone with a classic contraindication to MRI&#xD;
&#xD;
          -  Severe obesity&#xD;
&#xD;
          -  Gadolinium chelate allergy&#xD;
&#xD;
          -  &lt; 15 years&#xD;
&#xD;
          -  counter-indication to MRI examination&#xD;
&#xD;
          -  vulnerable person&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cedric Renard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cedric Renard, MD</last_name>
    <phone>+33 3 22 08 75 37</phone>
    <email>renard.cedric@chu-amiens.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cedric Renard, MD</last_name>
      <phone>+33 3 22 08 75 37</phone>
      <email>renard.cedric@chu-amiens.fr</email>
    </contact>
    <investigator>
      <last_name>Amel Mathiron, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>phase-contrast MRI</keyword>
  <keyword>blood flow</keyword>
  <keyword>velocity mapping</keyword>
  <keyword>Quantitative MRI</keyword>
  <keyword>Cardiac imaging</keyword>
  <keyword>Tetralogy of Fallot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetralogy of Fallot</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/NCT02980614
org study id: PI2016_843_0026
nct id: NCT02980614
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its
      branches inside the same sequence.
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its
      branches inside the same sequence. The objective of the project is to compare the regurgitant
      fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in
      repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization
      will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA
      flow +RightPA flow ? ).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Regurgitant fraction comparison
time frame: Day 0
description: The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow.
measure: Right ventricular volume
time frame: Day 0
description: The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences.
measure: Pulmonary arteries flows
time frame: Day 0
description: The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery (PA) tree (PA flow =LeftPA flow +RightPA flow ? ).
arm group label: Participants to 4D flow imaging
arm group type: Experimental
description: In addition to the standard clinical MR protocol, 2 added sequences:
4D MR sequence in cine mode 4D velocity mapping sequence
intervention type: Device
intervention name: 4D flow imaging
description: To compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery
arm group label: Participants to 4D flow imaging
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Cedric Renard, MD
role: Principal Investigator
affiliation: CHU Amiens
last name: Cedric Renard, MD
phone: +33 3 22 08 75 37
email: renard.cedric@chu-amiens.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Tetralogy of Fallot
sharing ipd: No