<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/NCT04475627</url>
  </required_header>
  <id_info>
    <org_study_id>0735</org_study_id>
    <nct_id>NCT04475627</nct_id>
  </id_info>
  <brief_title>Inter-field Strength Agreement of CMR Derived Strain</brief_title>
  <official_title>Inter-field Strength Agreement of Myocardial Strain Measurements Using Cardiovascular Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals, Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leicester</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>
      -  Magnetic Resonance Imaging (MRI) scanners create a strong magnetic field around the body&#xD;
           to produce a detailed picture of parts of the body. This can provide a lot of useful&#xD;
           information about how the heart looks and works.&#xD;
&#xD;
        -  Different strengths of magnets can be used in an MRI scanner and this can affect the&#xD;
           pictures that are produced. To scan the heart, two different magnet field strengths (1.5&#xD;
           tesla (T) and 3T) are mainly used.&#xD;
&#xD;
        -  It is currently unclear if when the heart is scanned using these different field&#xD;
           strengths, if the measurements that tell us how well the heart squeezes and relaxes&#xD;
           (known as 'myocardial strain') will be the same between them.&#xD;
&#xD;
        -  This study is investigating if myocardial strain measurements using 1.5T and 3T MRI&#xD;
           scanners are different or if they can be used interchangeably.&#xD;
&#xD;
        -  Twenty healthy people without heart disease will be recruited to have two MRI scans on&#xD;
           the same day. The order that they have their scan (either on a 1.5T MRI scanner first or&#xD;
           a 3T MRI scanner first) will be decided randomly.&#xD;
&#xD;
        -  All images will then be analysed using specialist software to provide measurements of&#xD;
           myocardial strain. These measured can then assessed to see if there is agreement between&#xD;
           the myocardial strain results at the two MRI field strengths.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  This is a single-centre, randomised, cross-sectional, cross-over observational study.&#xD;
&#xD;
        -  Twenty healthy volunteers, aged 18 years and over will be recruited and will undergo&#xD;
           cardiovascular magnetic resonance scans for long axis and short axis cine imaging at&#xD;
           1.5T and 3T.&#xD;
&#xD;
        -  Participation will involve one single visit where participants will be consented,&#xD;
           randomised and then undergo scanning at both field strengths; the order of scanning at&#xD;
           1.5T and 3T will be randomised. There will be no follow up period.&#xD;
&#xD;
        -  All subjects will undergo balanced steady-state free precession (bSSFP) cine imaging at&#xD;
           3T and 1.5T. Tagging images will also be acquired at both field strengths. Participants&#xD;
           will also be randomized to either have cine or tagging images obtained first on each&#xD;
           scan.&#xD;
&#xD;
        -  All scans at both field strengths will be anonymised and analysed offline by a single&#xD;
           experienced observer to determine inter-field strength agreement of left ventricular&#xD;
           systolic and diastolic strain measurements.&#xD;
&#xD;
        -  Further imaging analysis will take place for secondary outcomes, including analysis&#xD;
           using other software vendors, tagging images and aortic cine images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Actual">December 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Inter-field strength agreement of left ventricular global longitudinal strain (GLS)</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular global longitudinal strain (GLS) measured using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left ventricular global circumferential strain (GCS)</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular global circumferential strain (GCS) measured using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS)</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS) measured using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR)</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR)</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR)</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left ventricular peak torsion</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular peak torsion measured using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-vendor agreement of left ventricular systolic and diastolic strain measurements at 1.5T and 3T</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-vendor agreement of left ventricular systolic and diastolic strain measurements with different software packages (TomTec, QMass, cvi42) using cine-based imaging at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left ventricular systolic and diastolic strain measurements using cine-based imaging and tissue tagging techniques</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left ventricular systolic and diastolic strain measurements derived using cine-based imaging and tissue tagging techniques at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of left and right atrial and ventricular volumes and function</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of left and right atrial and ventricular volumes and function at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements using cvi42 Tissue Tracking at 1.5T and 3T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-field strength agreement of aortic strain</measure>
    <time_frame>Day 1</time_frame>
    <description>The inter-field strength agreement of aortic strain measured at 1.5T and 3T</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Participants randomised to 1.5T then 3T</arm_group_label>
    <description>Participants randomized to be scanned at 1.5T first followed by 3T</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants randomised to 3T then 1.5T</arm_group_label>
    <description>Participants randomized to be scanned at 3T first followed by 1.5T</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T</intervention_name>
    <description>Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.</description>
    <arm_group_label>Participants randomised to 1.5T then 3T</arm_group_label>
    <arm_group_label>Participants randomised to 3T then 1.5T</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiovascular Magnetic Resonance (CMR) imaging at 3T</intervention_name>
    <description>Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.</description>
    <arm_group_label>Participants randomised to 1.5T then 3T</arm_group_label>
    <arm_group_label>Participants randomised to 3T then 1.5T</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers, male and female, aged 18 years or above&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Understands written and verbal English sufficiently to be able to consent and&#xD;
             participate in study&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  No history of cardiovascular, respiratory, metabolic (including diabetes) or renal&#xD;
             disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior cardiovascular, respiratory, metabolic (including diabetes) or renal disease.&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the study, or may&#xD;
             influence the result of the study, or the participant's ability to participate in the&#xD;
             study.&#xD;
&#xD;
          -  Any contra-indication to magnetic resonance imaging (MRI), including the presence of&#xD;
             an implanted metal device or suspected metal foreign bodies.&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Leicester</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiovascular magnetic resonance</keyword>
  <keyword>left ventricular strain</keyword>
  <keyword>field strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT04475627
org study id: 0735
nct id: NCT04475627
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
-  Magnetic Resonance Imaging (MRI) scanners create a strong magnetic field around the body
           to produce a detailed picture of parts of the body. This can provide a lot of useful
           information about how the heart looks and works.

        -  Different strengths of magnets can be used in an MRI scanner and this can affect the
           pictures that are produced. To scan the heart, two different magnet field strengths (1.5
           tesla (T) and 3T) are mainly used.

        -  It is currently unclear if when the heart is scanned using these different field
           strengths, if the measurements that tell us how well the heart squeezes and relaxes
           (known as 'myocardial strain') will be the same between them.

        -  This study is investigating if myocardial strain measurements using 1.5T and 3T MRI
           scanners are different or if they can be used interchangeably.

        -  Twenty healthy people without heart disease will be recruited to have two MRI scans on
           the same day. The order that they have their scan (either on a 1.5T MRI scanner first or
           a 3T MRI scanner first) will be decided randomly.

        -  All images will then be analysed using specialist software to provide measurements of
           myocardial strain. These measured can then assessed to see if there is agreement between
           the myocardial strain results at the two MRI field strengths.
-  This is a single-centre, randomised, cross-sectional, cross-over observational study.

        -  Twenty healthy volunteers, aged 18 years and over will be recruited and will undergo
           cardiovascular magnetic resonance scans for long axis and short axis cine imaging at
           1.5T and 3T.

        -  Participation will involve one single visit where participants will be consented,
           randomised and then undergo scanning at both field strengths; the order of scanning at
           1.5T and 3T will be randomised. There will be no follow up period.

        -  All subjects will undergo balanced steady-state free precession (bSSFP) cine imaging at
           3T and 1.5T. Tagging images will also be acquired at both field strengths. Participants
           will also be randomized to either have cine or tagging images obtained first on each
           scan.

        -  All scans at both field strengths will be anonymised and analysed offline by a single
           experienced observer to determine inter-field strength agreement of left ventricular
           systolic and diastolic strain measurements.

        -  Further imaging analysis will take place for secondary outcomes, including analysis
           using other software vendors, tagging images and aortic cine images.
observational model: Other
time perspective: Cross-Sectional
measure: Inter-field strength agreement of left ventricular global longitudinal strain (GLS)
time frame: Day 1
description: The inter-field strength agreement of left ventricular global longitudinal strain (GLS) measured using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-field strength agreement of left ventricular global circumferential strain (GCS)
time frame: Day 1
description: The inter-field strength agreement of left ventricular global circumferential strain (GCS) measured using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS)
time frame: Day 1
description: The inter-field strength agreement of left ventricular short- and long-axis global radial strain (GRS) measured using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR)
time frame: Day 1
description: The inter-field strength agreement of left ventricular longitudinal peak early diastolic strain rate (long. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR)
time frame: Day 1
description: The inter-field strength agreement of left ventricular circumferential peak early diastolic strain rate (circum. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR)
time frame: Day 1
description: The inter-field strength agreement of left ventricular radial peak early diastolic strain rate (rad. PEDSR) measured using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-field strength agreement of left ventricular peak torsion
time frame: Day 1
description: The inter-field strength agreement of left ventricular peak torsion measured using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-vendor agreement of left ventricular systolic and diastolic strain measurements at 1.5T and 3T
time frame: Day 1
description: The inter-vendor agreement of left ventricular systolic and diastolic strain measurements with different software packages (TomTec, QMass, cvi42) using cine-based imaging at 1.5T and 3T
measure: Inter-field strength agreement of left ventricular systolic and diastolic strain measurements using cine-based imaging and tissue tagging techniques
time frame: Day 1
description: The inter-field strength agreement of left ventricular systolic and diastolic strain measurements derived using cine-based imaging and tissue tagging techniques at 1.5T and 3T
measure: Inter-field strength agreement of left and right atrial and ventricular volumes and function
time frame: Day 1
description: The inter-field strength agreement of left and right atrial and ventricular volumes and function at 1.5T and 3T
measure: Inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements
time frame: Day 1
description: The inter- and intra-observer variability of left ventricular systolic and diastolic strain measurements using cvi42 Tissue Tracking at 1.5T and 3T
measure: Inter-field strength agreement of aortic strain
time frame: Day 1
description: The inter-field strength agreement of aortic strain measured at 1.5T and 3T
arm group label: Participants randomised to 1.5T then 3T
description: Participants randomized to be scanned at 1.5T first followed by 3T
arm group label: Participants randomised to 3T then 1.5T
description: Participants randomized to be scanned at 3T first followed by 1.5T
intervention type: Diagnostic Test
intervention name: Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T
description: Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.
arm group label: Participants randomised to 1.5T then 3T
arm group label: Participants randomised to 3T then 1.5T
intervention type: Diagnostic Test
intervention name: Cardiovascular Magnetic Resonance (CMR) imaging at 3T
description: Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.
arm group label: Participants randomised to 1.5T then 3T
arm group label: Participants randomised to 3T then 1.5T
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No