<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/NCT01728597</url>
  </required_header>
  <id_info>
    <org_study_id>CMR-12-TECH-02</org_study_id>
    <nct_id>NCT01728597</nct_id>
  </id_info>
  <brief_title>Non-contrast Enhanced Cardiac Magnetic Resonance Normal Values and Imaging Protocols</brief_title>
  <acronym>CMR-TECH</acronym>
  <official_title>Optimization of Non-contrast Enhanced 1.5 Tesla and 3 Tesla Cardiac Magnetic Resonance Imaging Techniques and Acquisition of Normal Values</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amt der Steiermärkischen Landesregierung, Abteilung 3</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the main problems in cardiac magnetic resonance (MR) investigations is the strong&#xD;
      dependence of the achieved image quality on optimal settings of sequence parameters and&#xD;
      anatomical and physiological situations and it is well known that the diagnostic impact of&#xD;
      cardiac MR investigations crucially depends on the adaption of imaging protocols to patients'&#xD;
      state and ability to cooperate.&#xD;
&#xD;
      The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3&#xD;
      Tesla cardiac MR investigation protocols without application of contrast agent as well as the&#xD;
      acquisition of normal values for new cardiac MR images techniques:&#xD;
&#xD;
        -  normal myocardial morphology: T1-, T2- and T2*-weighted imaging and acquisition of&#xD;
           normal values of magnetic relaxation times (sequence- and protocol dependent),&#xD;
&#xD;
        -  normal cardiac function: systolic and diastolic function (sequence- and protocol&#xD;
           dependent),&#xD;
&#xD;
        -  coronary artery imaging: feasibility to evaluate length, diameter and blood flow&#xD;
           (sequence- and protocol dependent),&#xD;
&#xD;
        -  normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D&#xD;
           blood flow imaging and evaluation techniques (sequence- and protocol dependent).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cardiac volumes</measure>
    <time_frame>up to 1 week</time_frame>
    <description>volumes of cardiac chambers in the cardiac cycle [ml], sequence- and protocol dependent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiac performance</measure>
    <time_frame>up to 1 week</time_frame>
    <description>ejection fraction of cardiac chambers [%], sequence- and protocol dependent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiac muscle mass</measure>
    <time_frame>up to 1 week</time_frame>
    <description>systolic and end-diastolic mass of cardiac chambers [g], sequence- and protocol dependent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coronary artery anatomy</measure>
    <time_frame>up to 1 week</time_frame>
    <description>length and diameter [mm], sequence-, and protocol dependent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood flow velocity</measure>
    <time_frame>up to 1 week</time_frame>
    <description>maximum, minimum and average velocity [cm/s], sequence-, and protocol dependent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood flow vorticity</measure>
    <time_frame>up to 1 week</time_frame>
    <description>number of vortices of blood flow in the heart and surrounding great vessels, sequence and protocol dependent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood flow timing</measure>
    <time_frame>up to 1 week</time_frame>
    <description>time points of characteristic blood flow patterns in the heart and surrounding great vessels in the cardiac cycle [ms], sequence-, and protocol dependent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>magnetic relaxation times</measure>
    <time_frame>up to 1 week</time_frame>
    <description>systolic and diastolic T1, T2, T2* [ms], sequence- and protocol dependent</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <description>MR compliant volunteers with no history of cardiovascular diseases</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No history of cardiac or pulmonary diseases&#xD;
&#xD;
          -  ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General MR exclusion criteria eg. patients with metal devices or other magnetic&#xD;
             material in or on the subjects body which will be hazardous for MR investigation (e.g.&#xD;
             heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants,&#xD;
             coloured contact lenses, patch to deliver medications through the skin, any metal&#xD;
             implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or&#xD;
             any metal fragments or shrapnel in the body),&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  claustrophobia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ursula Reiter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Unitersity Graz, Department of Radiology, Division of General Radiology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ursula Reiter, PhD</last_name>
    <phone>+43-316-385</phone>
    <phone_ext>83347</phone_ext>
    <email>ursula.reiter@klinikum-graz.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Fuchsjäger, Prof. Dr.</last_name>
    <phone>+43-316-385</phone>
    <phone_ext>2411</phone_ext>
    <email>michael.fuchsjaeger@medunigraz.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical Unitersity Graz, Department of Radiology, Division of General Radiology</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Fuchsjäger, Prof. Dr.</last_name>
      <phone>+43-316-385</phone>
      <phone_ext>2411</phone_ext>
      <email>michael.fuchsjaeger@medunigraz.at</email>
    </contact>
    <contact_backup>
      <last_name>Ursula Reiter, PhD</last_name>
      <phone>+43-316-385</phone>
      <phone_ext>83347</phone_ext>
      <email>ursula.reiter@klinikum-graz.at</email>
    </contact_backup>
    <investigator>
      <last_name>Ursula Reiter, PD DI Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gert Reiter, PD DI Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Clemens Reiter, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Corina Kräuter, DI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Fuchsjäger, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Krauter C, Reiter U, Reiter C, Nizhnikava V, Masana M, Schmidt A, Fuchsjager M, Stollberger R, Reiter G. Automated mitral valve vortex ring extraction from 4D-flow MRI. Magn Reson Med. 2020 Dec;84(6):3396-3408. doi: 10.1002/mrm.28361. Epub 2020 Jun 18.</citation>
    <PMID>32557819</PMID>
  </reference>
  <results_reference>
    <citation>Reiter U, Reiter G, Dorr K, Greiser A, Maderthaner R, Fuchsjager M. Normal diastolic and systolic myocardial T1 values at 1.5-T MR imaging: correlations and blood normalization. Radiology. 2014 May;271(2):365-72. doi: 10.1148/radiol.13131225. Epub 2013 Dec 6.</citation>
    <PMID>24475837</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Graz</investigator_affiliation>
    <investigator_full_name>Ursula Reiter</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>no history of cardiovascular diseases</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/NCT01728597
org study id: CMR-12-TECH-02
nct id: NCT01728597
lead sponsor: 
collaborator: 
has dmc: Yes
One of the main problems in cardiac magnetic resonance (MR) investigations is the strong
      dependence of the achieved image quality on optimal settings of sequence parameters and
      anatomical and physiological situations and it is well known that the diagnostic impact of
      cardiac MR investigations crucially depends on the adaption of imaging protocols to patients'
      state and ability to cooperate.

      The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3
      Tesla cardiac MR investigation protocols without application of contrast agent as well as the
      acquisition of normal values for new cardiac MR images techniques:

        -  normal myocardial morphology: T1-, T2- and T2*-weighted imaging and acquisition of
           normal values of magnetic relaxation times (sequence- and protocol dependent),

        -  normal cardiac function: systolic and diastolic function (sequence- and protocol
           dependent),

        -  coronary artery imaging: feasibility to evaluate length, diameter and blood flow
           (sequence- and protocol dependent),

        -  normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D
           blood flow imaging and evaluation techniques (sequence- and protocol dependent).
observational model: Other
time perspective: Other
measure: cardiac volumes
time frame: up to 1 week
description: volumes of cardiac chambers in the cardiac cycle [ml], sequence- and protocol dependent
measure: cardiac performance
time frame: up to 1 week
description: ejection fraction of cardiac chambers [%], sequence- and protocol dependent
measure: cardiac muscle mass
time frame: up to 1 week
description: systolic and end-diastolic mass of cardiac chambers [g], sequence- and protocol dependent
measure: coronary artery anatomy
time frame: up to 1 week
description: length and diameter [mm], sequence-, and protocol dependent
measure: blood flow velocity
time frame: up to 1 week
description: maximum, minimum and average velocity [cm/s], sequence-, and protocol dependent
measure: blood flow vorticity
time frame: up to 1 week
description: number of vortices of blood flow in the heart and surrounding great vessels, sequence and protocol dependent
measure: blood flow timing
time frame: up to 1 week
description: time points of characteristic blood flow patterns in the heart and surrounding great vessels in the cardiac cycle [ms], sequence-, and protocol dependent
measure: magnetic relaxation times
time frame: up to 1 week
description: systolic and diastolic T1, T2, T2* [ms], sequence- and protocol dependent
arm group label: healthy volunteers
description: MR compliant volunteers with no history of cardiovascular diseases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ursula Reiter, PhD
role: Principal Investigator
affiliation: Medical Unitersity Graz, Department of Radiology, Division of General Radiology
last name: Ursula Reiter, PhD
phone: +43-316-385
phone ext: 83347
email: ursula.reiter@klinikum-graz.at
last name: Michael Fuchsjäger, Prof. Dr.
phone: +43-316-385
phone ext: 2411
email: michael.fuchsjaeger@medunigraz.at
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Austria
citation: Krauter C, Reiter U, Reiter C, Nizhnikava V, Masana M, Schmidt A, Fuchsjager M, Stollberger R, Reiter G. Automated mitral valve vortex ring extraction from 4D-flow MRI. Magn Reson Med. 2020 Dec;84(6):3396-3408. doi: 10.1002/mrm.28361. Epub 2020 Jun 18.
PMID: 32557819
citation: Reiter U, Reiter G, Dorr K, Greiser A, Maderthaner R, Fuchsjager M. Normal diastolic and systolic myocardial T1 values at 1.5-T MR imaging: correlations and blood normalization. Radiology. 2014 May;271(2):365-72. doi: 10.1148/radiol.13131225. Epub 2013 Dec 6.
PMID: 24475837
responsible party type: Principal Investigator
investigator affiliation: Medical University of Graz
investigator full name: Ursula Reiter
investigator title: PhD