<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/NCT03253835</url>
  </required_header>
  <id_info>
    <org_study_id>CMR-12-LHD</org_study_id>
    <nct_id>NCT03253835</nct_id>
  </id_info>
  <brief_title>Cardiac Blood Flow Patterns Associated With Left Ventricular Myocardial Damage</brief_title>
  <acronym>CMR-LHD</acronym>
  <official_title>Cardiac Blood Flow Patterns Associated With Regional and Global Left Ventricular Myocardial Damage: an Explorative Study by Cardiac Magnetic Resonance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anniversary Fund of the Oesterreichische Nationalbank</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</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>
      Various factors affect the performance of the heart: The contractile properties of myocardial&#xD;
      muscle cells are the fundamental devices for translating tension-generation and shortening of&#xD;
      the cardiac muscle into pressure-generation and blood volume ejection from the heart into the&#xD;
      body. On the other hand, the performance of heart can be analyzed with respect to input and&#xD;
      output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance&#xD;
      of a pump: With every heartbeat blood is sucked from a low-pressure system (veins) and pumped&#xD;
      to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood&#xD;
      volume, blood flow and pressures are linked by hemodynamic laws.&#xD;
&#xD;
      Cardiac magnetic resonance (CMR) is the &quot;gold standard technique&quot; to determine cardiac&#xD;
      function and muscle mass, as well as for non-invasive diagnosis of myocardial&#xD;
      necrosis/fibrosis. Furthermore, new CMR imaging techniques enabling the measurement of&#xD;
      myocardial magnetic relaxation times for characterization of myocardial morphology and the&#xD;
      acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and&#xD;
      surrounding vessels, represent promising tools for the evaluation of the interaction between&#xD;
      myocardial morphology and cardiac function.&#xD;
&#xD;
      Aim of this explorative study is to 1. identify myocardial pathology-associated blood flow&#xD;
      patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood&#xD;
      flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation&#xD;
      dynamics …) with myocardial injuries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 21, 2013</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels</measure>
    <time_frame>2 years</time_frame>
    <description>Morphologic, functional and blood flow CMR parameters will be evaluated with different techniques. Cardiac blood flow pattern parameters will be correlated with myocardial injury derived non-invasively from late gadolinium enhancement</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cardiomyopathies</condition>
  <condition>Myocardial Injury</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Myocardial Injury</arm_group_label>
    <description>patients with myocardial injuries due to ischemic heart disease, patients with myocardial injuries due to non-ischemic heart disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Myocardial Injury</arm_group_label>
    <description>subjects without myocardial injuries with normal cardiac function subjects without myocardial injuries with altered cardiac function</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Single Group Assignment</intervention_name>
    <arm_group_label>Myocardial Injury</arm_group_label>
    <arm_group_label>No Myocardial Injury</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to CMR investigation. If suitable and inclusion criteria are met, the&#xD;
        patient will be asked if she/he is interested in participating in this study. Participation&#xD;
        means, that aside from the respective routine CMR protocol, additional images will be taken&#xD;
        within the investigation resulting in 15-20 minutes extra investigation time.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients age 20-80 years,&#xD;
&#xD;
          -  patients with and without ischemic or non-ischemic myocardial injuries scheduled for&#xD;
             routine cardiac magnetic resonance imaging,&#xD;
&#xD;
          -  ability to hold the breath,&#xD;
&#xD;
          -  ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with metal devices or other magnetic material in or on the subjects body&#xD;
             which will be hazardous for magnetic resonance investigation (e.g. heart pace-maker,&#xD;
             brain aneurysm clip, nerve stimulators, electrodes, penile implants, colored contact&#xD;
             lenses, patch to deliver medications through the skin, any metal implants as rods,&#xD;
             joints, plates, pins, screws, nails or clips, embolization coil, or any metal&#xD;
             fragments or shrapnel in the body),&#xD;
&#xD;
          -  patients with tendency toward claustrophobia,&#xD;
&#xD;
          -  hemodynamically unstable patients,&#xD;
&#xD;
          -  patients with (major) arrhythmia&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  impaired kidney function indicated by creatin clearance lower than 60 ml/min (creatin&#xD;
             clearance will be calculated according to Cockroft-Gault formula)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Michael Fuchsjäger, Univ.-Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Medical Universtiy of Graz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ursula Reiter, PD DI Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Universtiy of Graz</affiliation>
  </overall_official>
  <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>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Krauter C, Reiter U, Reiter C, Nizhnikava V, Schmidt A, Stollberger R, Fuchsjager M, Reiter G. Impact of the Choice of Native T1 in Pixelwise Myocardial Blood Flow Quantification. J Magn Reson Imaging. 2021 Mar;53(3):755-765. doi: 10.1002/jmri.27375. Epub 2020 Oct 8.</citation>
    <PMID>33034120</PMID>
  </reference>
  <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>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</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>PD DI Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</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/NCT03253835
org study id: CMR-12-LHD
nct id: NCT03253835
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Various factors affect the performance of the heart: The contractile properties of myocardial
      muscle cells are the fundamental devices for translating tension-generation and shortening of
      the cardiac muscle into pressure-generation and blood volume ejection from the heart into the
      body. On the other hand, the performance of heart can be analyzed with respect to input and
      output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance
      of a pump: With every heartbeat blood is sucked from a low-pressure system (veins) and pumped
      to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood
      volume, blood flow and pressures are linked by hemodynamic laws.

      Cardiac magnetic resonance (CMR) is the "gold standard technique" to determine cardiac
      function and muscle mass, as well as for non-invasive diagnosis of myocardial
      necrosis/fibrosis. Furthermore, new CMR imaging techniques enabling the measurement of
      myocardial magnetic relaxation times for characterization of myocardial morphology and the
      acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and
      surrounding vessels, represent promising tools for the evaluation of the interaction between
      myocardial morphology and cardiac function.

      Aim of this explorative study is to 1. identify myocardial pathology-associated blood flow
      patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood
      flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation
      dynamics …) with myocardial injuries.
observational model: Cohort
time perspective: Prospective
measure: Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels
time frame: 2 years
description: Morphologic, functional and blood flow CMR parameters will be evaluated with different techniques. Cardiac blood flow pattern parameters will be correlated with myocardial injury derived non-invasively from late gadolinium enhancement
arm group label: Myocardial Injury
description: patients with myocardial injuries due to ischemic heart disease, patients with myocardial injuries due to non-ischemic heart disease.
arm group label: No Myocardial Injury
description: subjects without myocardial injuries with normal cardiac function subjects without myocardial injuries with altered cardiac function
intervention type: Diagnostic Test
intervention name: Single Group Assignment
arm group label: Myocardial Injury
arm group label: No Myocardial Injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
last name: Michael Fuchsjäger, Univ.-Prof.
role: Study Chair
affiliation: Medical Universtiy of Graz
last name: Ursula Reiter, PD DI Dr.
role: Principal Investigator
affiliation: Medical Universtiy of Graz
facility: 
country: Austria
citation: Krauter C, Reiter U, Reiter C, Nizhnikava V, Schmidt A, Stollberger R, Fuchsjager M, Reiter G. Impact of the Choice of Native T1 in Pixelwise Myocardial Blood Flow Quantification. J Magn Reson Imaging. 2021 Mar;53(3):755-765. doi: 10.1002/jmri.27375. Epub 2020 Oct 8.
PMID: 33034120
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
responsible party type: Principal Investigator
investigator affiliation: Medical University of Graz
investigator full name: Ursula Reiter
investigator title: PD DI Dr.
mesh term: Cardiomyopathies
sharing ipd: No