<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/NCT01678040</url>
  </required_header>
  <id_info>
    <org_study_id>1000031585</org_study_id>
    <nct_id>NCT01678040</nct_id>
  </id_info>
  <brief_title>Ventricular Volume as Assessed by Cardiac Magnetic Resonance</brief_title>
  <official_title>MRI Assessment of the Effect of Preload on Ventricular Volumes and Function in Healthy Adult Volunteers</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>
      One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right&#xD;
      ventricular (RV) volumes. There are a number of congenital heart defects and acquired&#xD;
      conditions in which management decisions are fundamentally based on ventricular volumes. The&#xD;
      &quot;gold standard&quot; for assessment of RV volume is CMR. It has better near-field resolution than&#xD;
      echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable&#xD;
      to the irregular geometry of the RV. The objectives of this study are (1) to assess&#xD;
      ventricular volumes in the fasting state and after oral hydration in order to assess the&#xD;
      effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect&#xD;
      of hydration on ventricular volumes compared the effect of with inter-observer and&#xD;
      intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber&#xD;
      deformation, including strain and peak strain rate. This study hypothesizes that (1)&#xD;
      hydration status has an effect on right and left heart volumes, measured by CMR in healthy&#xD;
      volunteers; (2) the effect of volume status will be a more significant contributor to&#xD;
      variability in RV volumetry than that of inter-observer variability and intra-observer&#xD;
      variability, and; (3) atrial and Ventricular deformation corrected for chamber size or volume&#xD;
      is more accurate than when uncorrected for volume.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To assess ventricular volumes in the fasting state and after oral hydration in order to&#xD;
           assess the effect of fluid status on ventricular volumes as measured by CMR.&#xD;
&#xD;
        2. To evaluate the effect of hydration on ventricular volumes compared the effect of with&#xD;
           inter-observer and intra-observer variability.&#xD;
&#xD;
        3. To evaluate the effects of chamber volume on chamber deformation, including strain and&#xD;
           peak strain rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fluid Status</measure>
    <time_frame>Day 1</time_frame>
    <description>To assess ventricular volumes in the fasting state and after oral hydration in order to assess the effect of fluid status on ventricular volumes as measured by CMR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hydration</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chamber Deformation</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Arrhythmogenic Right Ventricular Cardiomyophathy (ARVC)</condition>
  <arm_group>
    <arm_group_label>Cardiac Magnetic Resonance</arm_group_label>
    <description>The CMR examinations will be performed in the cardiac MRI scanner (Siemens &quot;Avanto&quot;, 1.5 Tesla, Erlangen, Germany) at the Hospital for Sick Children. A brief echocardiogram will be performed using a GE Vivid 7 or Vivid E9 machine (General Electric Medical Systems, Wisconsin, USA) We will image from standard parasternal long axis and apical four-chamber before and after completed hydration.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Staff from the Heart Centre at The Hospital for Sick Children will be sent an email&#xD;
        notifying them of the study. They will be invited to obtain the particulars of the study by&#xD;
        replying to Dr. Daryl Schantz or Dr. Lars Grosse-Wortmann. If they agree to participate Dr.&#xD;
        Schantz will obtain written informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must be healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are unable to participate in an overnight fast will be excluded&#xD;
&#xD;
          -  Those with known or suspected structural heart disease will be excluded&#xD;
&#xD;
          -  A screening form to identify pre-existing cardiac conditions will be completed by the&#xD;
             subject prior to participation in this study. If a pre-existing condition cardiac&#xD;
             condition is identified, or suspected they will be excluded from the study.&#xD;
&#xD;
          -  If any functional abnormality is detected at any stage by echocardiography or by CMR&#xD;
             the study will be terminated. Common anatomical variants, which are generally regarded&#xD;
             as normal variants (such as a patent foramen ovale, or a persistent left superior vena&#xD;
             cava) will not lead to exclusion from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Grosse-Wortmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <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>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>July 9, 2019</last_update_submitted>
  <last_update_submitted_qc>July 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2019</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>Lars Grosse-Wortmann</investigator_full_name>
    <investigator_title>Staff Cardiologist</investigator_title>
  </responsible_party>
  <keyword>Ventricular Volume</keyword>
  <keyword>Cardiac Magnetic Resonance</keyword>
  <keyword>Echocardiogram</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/NCT01678040
org study id: 1000031585
nct id: NCT01678040
lead sponsor: 
has dmc: No
One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right
      ventricular (RV) volumes. There are a number of congenital heart defects and acquired
      conditions in which management decisions are fundamentally based on ventricular volumes. The
      "gold standard" for assessment of RV volume is CMR. It has better near-field resolution than
      echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable
      to the irregular geometry of the RV. The objectives of this study are (1) to assess
      ventricular volumes in the fasting state and after oral hydration in order to assess the
      effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect
      of hydration on ventricular volumes compared the effect of with inter-observer and
      intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber
      deformation, including strain and peak strain rate. This study hypothesizes that (1)
      hydration status has an effect on right and left heart volumes, measured by CMR in healthy
      volunteers; (2) the effect of volume status will be a more significant contributor to
      variability in RV volumetry than that of inter-observer variability and intra-observer
      variability, and; (3) atrial and Ventricular deformation corrected for chamber size or volume
      is more accurate than when uncorrected for volume.
1. To assess ventricular volumes in the fasting state and after oral hydration in order to
           assess the effect of fluid status on ventricular volumes as measured by CMR.

        2. To evaluate the effect of hydration on ventricular volumes compared the effect of with
           inter-observer and intra-observer variability.

        3. To evaluate the effects of chamber volume on chamber deformation, including strain and
           peak strain rate.
observational model: Cohort
time perspective: Prospective
measure: Fluid Status
time frame: Day 1
description: To assess ventricular volumes in the fasting state and after oral hydration in order to assess the effect of fluid status on ventricular volumes as measured by CMR.
measure: Hydration
time frame: Day 1
description: To evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability.
measure: Chamber Deformation
time frame: Day 1
description: To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate
arm group label: Cardiac Magnetic Resonance
description: The CMR examinations will be performed in the cardiac MRI scanner (Siemens "Avanto", 1.5 Tesla, Erlangen, Germany) at the Hospital for Sick Children. A brief echocardiogram will be performed using a GE Vivid 7 or Vivid E9 machine (General Electric Medical Systems, Wisconsin, USA) We will image from standard parasternal long axis and apical four-chamber before and after completed hydration.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lars Grosse-Wortmann, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Lars Grosse-Wortmann
investigator title: Staff Cardiologist