<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/NCT01668264</url>
  </required_header>
  <id_info>
    <org_study_id>1000017963</org_study_id>
    <nct_id>NCT01668264</nct_id>
  </id_info>
  <brief_title>Imaging Assessment of Diastolic Function</brief_title>
  <official_title>Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diastolic function is poorly studied in children with congenital heart disease. This is&#xD;
      mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to&#xD;
      echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue&#xD;
      characterization. The main advantage of echocardiography is a better temporal resolution&#xD;
      which allows the study of short events like early relaxation. Overall there is a lack of&#xD;
      studies correlating different echocardiographic and MRI parameters of heart function in&#xD;
      pediatric populations with congenital or acquired heart diseases. This study will address&#xD;
      specific questions on specific groups of patients that might bring more insight into chamber&#xD;
      interaction and cardiac function. This study hypothesizes the following:&#xD;
&#xD;
        -  Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo&#xD;
           might be the best method for follow-up.&#xD;
&#xD;
        -  Cardiac remodeling associated with chronic loading results in changes in diastolic&#xD;
           properties related to changes in cardiac mass and volume. This is related to changes in&#xD;
           cardiac mechanics influencing diastolic parameters. Especially the influence on twisting&#xD;
           and untwisting will be studied.&#xD;
&#xD;
        -  Regional myocardial fibrosis and scarring may account for regional systolic and&#xD;
           diastolic dysfunction with possible prognostic impact&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial Volumes</measure>
    <time_frame>Day 1</time_frame>
    <description>Measure right and left atrial volumes by 2D and 3D echo and correlate the different echocardiographic measurements with MRI. This will allow identifying the most accurate measurement which can be used in clinical practice.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess Ventricular Volumes</measure>
    <time_frame>Day 1</time_frame>
    <description>Assess ventricular volumes and mass and calculate mass/volume ratio. Study the effect of ventricular remodeling on myocardial mechanics especially twisting and untwisting. Relate these changes to evaluation of diastolic function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Scarring</measure>
    <time_frame>Day 1</time_frame>
    <description>Assess the presence of myocardial scarring in specific populations with congenital heart disease and correlate the findings with regional and global systolic and diastolic dysfunction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Echocardiograph</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Echocardiograph</intervention_name>
    <arm_group_label>Echocardiograph</arm_group_label>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <arm_group_label>Echocardiograph</arm_group_label>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with tetralogy of Fallot post repair, transposition of great arteries&#xD;
             after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic&#xD;
             regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to&#xD;
             undergo a cardiac MRI will be eligible.&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  Need for general anesthesia&#xD;
&#xD;
          -  Similar contraindications as for a clinical MRI study apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luc Mertens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luc Mertens, MD</last_name>
    <phone>(416)813-7418</phone>
    <email>luc.mertens@sickkids.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Luc Mertens, MD</last_name>
      <phone>(416)813-7418</phone>
      <email>luc.mertens@sickkids.ca</email>
    </contact>
    <investigator>
      <last_name>Luc Mertens, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andreea Dragulescu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lars Grosse-Wortmann, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shi-Joon Yoo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edgar Jaeggi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark Friedberg, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>June 22, 2016</last_update_submitted>
  <last_update_submitted_qc>June 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Luc Mertens</investigator_full_name>
    <investigator_title>Staff Cardiologist</investigator_title>
  </responsible_party>
  <keyword>Pediatrics</keyword>
  <keyword>Congenital Heart Disease</keyword>
  <keyword>Diastolic Function</keyword>
  <keyword>Echocardiograph</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT01668264
org study id: 1000017963
nct id: NCT01668264
lead sponsor: 
has dmc: No
Diastolic function is poorly studied in children with congenital heart disease. This is
      mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to
      echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue
      characterization. The main advantage of echocardiography is a better temporal resolution
      which allows the study of short events like early relaxation. Overall there is a lack of
      studies correlating different echocardiographic and MRI parameters of heart function in
      pediatric populations with congenital or acquired heart diseases. This study will address
      specific questions on specific groups of patients that might bring more insight into chamber
      interaction and cardiac function. This study hypothesizes the following:

        -  Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo
           might be the best method for follow-up.

        -  Cardiac remodeling associated with chronic loading results in changes in diastolic
           properties related to changes in cardiac mass and volume. This is related to changes in
           cardiac mechanics influencing diastolic parameters. Especially the influence on twisting
           and untwisting will be studied.

        -  Regional myocardial fibrosis and scarring may account for regional systolic and
           diastolic dysfunction with possible prognostic impact
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Atrial Volumes
time frame: Day 1
description: Measure right and left atrial volumes by 2D and 3D echo and correlate the different echocardiographic measurements with MRI. This will allow identifying the most accurate measurement which can be used in clinical practice.
measure: Assess Ventricular Volumes
time frame: Day 1
description: Assess ventricular volumes and mass and calculate mass/volume ratio. Study the effect of ventricular remodeling on myocardial mechanics especially twisting and untwisting. Relate these changes to evaluation of diastolic function.
measure: Myocardial Scarring
time frame: Day 1
description: Assess the presence of myocardial scarring in specific populations with congenital heart disease and correlate the findings with regional and global systolic and diastolic dysfunction.
arm group label: Magnetic Resonance Imaging (MRI)
arm group type: Experimental
description: Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
arm group label: Echocardiograph
arm group type: Experimental
description: Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
intervention type: Procedure
intervention name: Echocardiograph
arm group label: Echocardiograph
arm group label: Magnetic Resonance Imaging (MRI)
intervention type: Procedure
intervention name: Magnetic Resonance Imaging (MRI)
arm group label: Echocardiograph
arm group label: Magnetic Resonance Imaging (MRI)
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: Luc Mertens, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Luc Mertens, MD
phone: (416)813-7418
email: luc.mertens@sickkids.ca
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Luc Mertens
investigator title: Staff Cardiologist
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital