<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/NCT03234205</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A00154-37</org_study_id>
    <nct_id>NCT03234205</nct_id>
  </id_info>
  <brief_title>Measurements of Myocardial Relaxation Time by MRI During Respiration</brief_title>
  <acronym>ARTEMIS</acronym>
  <official_title>Measurements of Myocardial Relaxation Time by MRI During Respiration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in&#xD;
      cardiac imagery. It has been initially used for quantitative evaluation of heart viability&#xD;
      and more recently for edema characterization. It allows to prematurely detect a cardiac&#xD;
      transplant rejection. This technique needs successively around ten FSE sequences during&#xD;
      apnea. Weak reproducibility of successive apneas and discomfort of patient limit the&#xD;
      precision of this measurement and consequently its use in standard care. The ARTEMIS study&#xD;
      method allows the examination during free respiration without prolonging the duration of&#xD;
      examination compared to the examination during apnea. Moreover, image processing is&#xD;
      simplified and correction of respiratory movements renders results more reliable.&#xD;
&#xD;
      This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is&#xD;
      a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows&#xD;
      to obtain diagnostic images without movement artifacts.&#xD;
&#xD;
      The primary objective si to show the feasibility of ARTEMIS method for measurement of&#xD;
      myocardial T2 relaxation time during free respiration in cardiac transplant patients.&#xD;
&#xD;
      The secondary objective is to collect quantitative data to compare ARTEMIS method of&#xD;
      measurement of T2 during free respiration and standard clinical practice during apnea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2011</start_date>
  <completion_date type="Actual">December 19, 2012</completion_date>
  <primary_completion_date type="Actual">December 19, 2012</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Image quality assessed y senior radiologists</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Movement correction in images assessed by senior radiologists</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative measurement of myocardial transversal relaxation time in 6 segments of short median axe cross-section of left ventricle in standard and ARTEMIS images</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Heart Transplantation</condition>
  <arm_group>
    <arm_group_label>MRI scan during free respiration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI scan</intervention_name>
    <description>MRI standard protocol with addition of:&#xD;
a second clinical respiratory belt besides belt usually installed for clinical examination&#xD;
a second clinical electrocardiogram sensor besides sensor usually installed for clinical examination&#xD;
12 sequences during free respiration are added lasting supplementary 15 minutes&#xD;
Use of cardiac antennae usually used for cardiac MRI scans</description>
    <arm_group_label>MRI scan during free respiration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To have had a heart transplant, whenever&#xD;
&#xD;
          -  To have an MRI scan of heart with measurement of T2 relaxation time (whatever the&#xD;
             reason for examination)&#xD;
&#xD;
          -  Major&#xD;
&#xD;
          -  To be aware and cooperative&#xD;
&#xD;
          -  Affiliation to social security plan&#xD;
&#xD;
          -  To have given written consent after having received oral and written, clear and&#xD;
             intelligible information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All contraindications to MRI (implantable defibrillator, cochlear implant,&#xD;
             neurosurgical clip, intraorbital or encephalic metallic foreign body, endoprosthesis&#xD;
             installed since less than 4 weeks, osteosynthesis materials installed since less than&#xD;
             6 weeks…)&#xD;
&#xD;
          -  Instable hemodynamic status, acute respiratory failure, uncertain general status or&#xD;
             necessity of continuous monitoring incompatible with MRI examination&#xD;
&#xD;
          -  Minors or being under juridical protection or absence of social security&#xD;
&#xD;
          -  Refusal or impossibility of informed consent of patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Nancy Brabois</name>
      <address>
        <city>Vandoeuvre les nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03234205
org study id: 2011-A00154-37
nct id: NCT03234205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in
      cardiac imagery. It has been initially used for quantitative evaluation of heart viability
      and more recently for edema characterization. It allows to prematurely detect a cardiac
      transplant rejection. This technique needs successively around ten FSE sequences during
      apnea. Weak reproducibility of successive apneas and discomfort of patient limit the
      precision of this measurement and consequently its use in standard care. The ARTEMIS study
      method allows the examination during free respiration without prolonging the duration of
      examination compared to the examination during apnea. Moreover, image processing is
      simplified and correction of respiratory movements renders results more reliable.

      This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is
      a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows
      to obtain diagnostic images without movement artifacts.

      The primary objective si to show the feasibility of ARTEMIS method for measurement of
      myocardial T2 relaxation time during free respiration in cardiac transplant patients.

      The secondary objective is to collect quantitative data to compare ARTEMIS method of
      measurement of T2 during free respiration and standard clinical practice during apnea.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Image quality assessed y senior radiologists
time frame: baseline
measure: Movement correction in images assessed by senior radiologists
time frame: baseline
measure: Quantitative measurement of myocardial transversal relaxation time in 6 segments of short median axe cross-section of left ventricle in standard and ARTEMIS images
time frame: baseline
arm group label: MRI scan during free respiration
arm group type: Experimental
intervention type: Device
intervention name: MRI scan
description: MRI standard protocol with addition of:
a second clinical respiratory belt besides belt usually installed for clinical examination
a second clinical electrocardiogram sensor besides sensor usually installed for clinical examination
12 sequences during free respiration are added lasting supplementary 15 minutes
Use of cardiac antennae usually used for cardiac MRI scans
arm group label: MRI scan during free respiration
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No