<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/NCT01712581</url>
  </required_header>
  <id_info>
    <org_study_id>2012/071/HP</org_study_id>
    <nct_id>NCT01712581</nct_id>
  </id_info>
  <brief_title>Heart Map Study -Determination of Myocardial Relaxation Times Values in Healthy Volunters</brief_title>
  <acronym>HeartMS</acronym>
  <official_title>Determination of Myocardial Relaxation Times Values in Healthy Volunters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial&#xD;
      tissue content (water, fibrosis, iron).&#xD;
&#xD;
      The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in&#xD;
      healthy volunters aged 18-69 years using 1.5T clinical MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac MRI is more and more used in patients with ischaemic and non-ischaemic heart&#xD;
      diseases. One major strength of MRI is its great potential for tissue characterization.&#xD;
&#xD;
      For early detection and follow-up of patients with hemosiderosis, who are at high risk of&#xD;
      myocardial iron overload, cardiac MRI seems to be the most reliable, more reproducible and&#xD;
      less invasive method. In addition MRI does not require injection of contrast media. It is&#xD;
      commonly accepted that myocardial T2 * value of less than 20 ms corresponds to iron overload&#xD;
      in the myocardium. However, this value is based on a small sample study and nomogram based on&#xD;
      age were not published. The determination of normal values in a population of healthy&#xD;
      controls according to age appears to be a prerequisite for reliable interpretation of imaging&#xD;
      data.&#xD;
&#xD;
      Moreover, myocardial edema and fibrosis are more and more evaluated with cardiac MRI using T1&#xD;
      and T2 myocardial relaxation times. As for T2* values, normogram of T1 and T2 values based on&#xD;
      age were not published.&#xD;
&#xD;
      The increasing use of T1, T2 and T2* mapping sequences in clinical practice for tissue&#xD;
      characterization of the myocardium justify the implementation of a study in healthy&#xD;
      volunteers to determine normograms based on age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>The main objective is to determine normal T2 * values of the myocardium in a large adult population of healthy volunteers, using 1.5T cardiac MRI.</measure>
    <time_frame>24h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary objectives are to determine normal T1 and T2 values of the myocardium in a large adult population of healthy volunteers, using 1.5T cardiac MRI.</measure>
    <time_frame>24h</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Normal Myocardial T1, T2 and T2* Values</condition>
  <arm_group>
    <arm_group_label>Healthy volunters</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>175 Healthy volunters in the cohorte divided in 7 groups of age: 18-19 years old (ratio M/F: 1/1) 20-24 years old (ratio M/F: 1/1) 25-29 years old (ratio M/F: 1/1) 30-39 years old (ratio M/F: 1/1) 40-49 years old (ratio M/F: 1/1) 50-59 years old (ratio M/F: 1/1) 60-69 years old (ratio M/F: 1/1)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <arm_group_label>Healthy volunters</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers over the age of 18 and less than 70&#xD;
&#xD;
          -  Volunteers able to understand and sign the consent and to give written informed&#xD;
             consent&#xD;
&#xD;
          -  Female contraceptives if of childbearing age&#xD;
&#xD;
          -  Registered or entitled to social security system&#xD;
&#xD;
          -  Volunteers able to maintain supine for 20 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major protected/under guardianship&#xD;
&#xD;
          -  Volunteers unable to maintain the supine position for 20 minutes&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Volunteers with history of PRBC transfusion&#xD;
&#xD;
          -  Volunteers with history of hematologic disease or a disruption of iron status&#xD;
&#xD;
          -  Volunteers with history of cardiac disease including arrhythmias&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Contra-indication for MRI: metal fragments in the eyes; implantable cardiac,&#xD;
             neurological or ENT device; osteosynhesis material not compatible with MRI&#xD;
&#xD;
          -  Women who are pregnant or likely to be&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>normal myocardial T1, T2 and T2* values</keyword>
  <!-- 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/NCT01712581
org study id: 2012/071/HP
nct id: NCT01712581
lead sponsor: 
collaborator: 
has dmc: Yes
T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial
      tissue content (water, fibrosis, iron).

      The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in
      healthy volunters aged 18-69 years using 1.5T clinical MRI.
Cardiac MRI is more and more used in patients with ischaemic and non-ischaemic heart
      diseases. One major strength of MRI is its great potential for tissue characterization.

      For early detection and follow-up of patients with hemosiderosis, who are at high risk of
      myocardial iron overload, cardiac MRI seems to be the most reliable, more reproducible and
      less invasive method. In addition MRI does not require injection of contrast media. It is
      commonly accepted that myocardial T2 * value of less than 20 ms corresponds to iron overload
      in the myocardium. However, this value is based on a small sample study and nomogram based on
      age were not published. The determination of normal values in a population of healthy
      controls according to age appears to be a prerequisite for reliable interpretation of imaging
      data.

      Moreover, myocardial edema and fibrosis are more and more evaluated with cardiac MRI using T1
      and T2 myocardial relaxation times. As for T2* values, normogram of T1 and T2 values based on
      age were not published.

      The increasing use of T1, T2 and T2* mapping sequences in clinical practice for tissue
      characterization of the myocardium justify the implementation of a study in healthy
      volunteers to determine normograms based on age.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: The main objective is to determine normal T2 * values of the myocardium in a large adult population of healthy volunteers, using 1.5T cardiac MRI.
time frame: 24h
measure: The secondary objectives are to determine normal T1 and T2 values of the myocardium in a large adult population of healthy volunteers, using 1.5T cardiac MRI.
time frame: 24h
arm group label: Healthy volunters
arm group type: Experimental
description: 175 Healthy volunters in the cohorte divided in 7 groups of age: 18-19 years old (ratio M/F: 1/1) 20-24 years old (ratio M/F: 1/1) 25-29 years old (ratio M/F: 1/1) 30-39 years old (ratio M/F: 1/1) 40-49 years old (ratio M/F: 1/1) 50-59 years old (ratio M/F: 1/1) 60-69 years old (ratio M/F: 1/1)
intervention type: Other
intervention name: Magnetic Resonance Imaging
arm group label: Healthy volunters
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor