<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/NCT01725763</url>
  </required_header>
  <id_info>
    <org_study_id>CMR-12-PH</org_study_id>
    <nct_id>NCT01725763</nct_id>
  </id_info>
  <brief_title>Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension</brief_title>
  <acronym>CMR-PH</acronym>
  <official_title>Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary hypertension (PH) is a life-threatening cardiovascular disease characterized by&#xD;
      pathological elevation of mean pulmonary arterial pressure (mPAP) &gt;/= 25 mmHg at rest. mPAP &lt;&#xD;
      20 mmHg is defined as normal, values in the range between 21-24 mmHg are described as&#xD;
      &quot;borderline PH&quot; diagnosed by right heart catheterization. Based on the etiology, PH is&#xD;
      assigned to 5 groups (WHO, Data Point, 2008), whereas classification of disease is an&#xD;
      important prognostic and therapy-deciding criterion.&#xD;
&#xD;
      Cardiac magnetic resonance tomography (CMR) provides a reliable technique to estimate&#xD;
      elevated mean pulmonary arterial pressure from period of existence of a vortical motion of&#xD;
      blood flow in the main pulmonary artery. Vortex can be visualized in 3-dimensional vector&#xD;
      field, particle trace and streamline representations and can be analysed with respect to&#xD;
      vortex related measures (geometry of center, vortex formation, vorticity, propagation&#xD;
      dynamics …). Furthermore T1-mapping and non-contrast enhanced lung perfusion/ventilation&#xD;
      scans represent promising techniques for PH characterization.&#xD;
&#xD;
      Aim of this explorative study is to 1. analyse PH-associated blood flow characteristics in&#xD;
      the heart and the surrounding great vessels with respect to the 5 groups of PH, and 2.&#xD;
      investigate the hemodynamic state of &quot;borderline PH&quot; compared to normal mPAP and manifest PH&#xD;
      by non-contrast CMR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood flow patterns</measure>
    <time_frame>2 years</time_frame>
    <description>fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>myocardial magnetic relaxation times</measure>
    <time_frame>2 years</time_frame>
    <description>left and right ventricular myocardial T1 times associated with ethiology of PH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary ventilation and perfusion</measure>
    <time_frame>2 years</time_frame>
    <description>pulmonary ventilation and perfusion associated with ethiology of PH</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <condition>Elevated Mean Pulmonary Arterial Pressure</condition>
  <condition>Normal Mean Pulmonary Arterial Pressure</condition>
  <arm_group>
    <arm_group_label>suspected PH</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>60 minute Cardiac MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiac MRI</intervention_name>
    <arm_group_label>suspected PH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with suspected or known PH scheduled for routine right-heart catheterization,&#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;
          -  patients with tendency toward claustrophobia,&#xD;
&#xD;
          -  hemodynamically unstable patients,&#xD;
&#xD;
          -  pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</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_official>
    <last_name>Michael Fuchsjäger, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Unitersity Graz, Department of Radiology, Division of General Radiology</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>Reiter U, Kovacs G, Reiter C, Krauter C, Nizhnikava V, Fuchsjager M, Olschewski H, Reiter G. MR 4D flow-based mean pulmonary arterial pressure tracking in pulmonary hypertension. Eur Radiol. 2021 Apr;31(4):1883-1893. doi: 10.1007/s00330-020-07287-6. Epub 2020 Sep 24.</citation>
    <PMID>32974687</PMID>
  </reference>
  <results_reference>
    <citation>Reiter U, Reiter G, Kovacs G, Stalder AF, Gulsun MA, Greiser A, Olschewski H, Fuchsjager M. Evaluation of elevated mean pulmonary arterial pressure based on magnetic resonance 4D velocity mapping: comparison of visualization techniques. PLoS One. 2013 Dec 12;8(12):e82212. doi: 10.1371/journal.pone.0082212. eCollection 2013.</citation>
    <PMID>24349224</PMID>
  </results_reference>
  <results_reference>
    <citation>Reiter G, Reiter U, Kovacs G, Olschewski H, Fuchsjager M. Blood flow vortices along the main pulmonary artery measured with MR imaging for diagnosis of pulmonary hypertension. Radiology. 2015 Apr;275(1):71-9. doi: 10.1148/radiol.14140849. Epub 2014 Nov 5.</citation>
    <PMID>25372980</PMID>
  </results_reference>
  <results_reference>
    <citation>Reiter U, Reiter G, Fuchsjager M. MR phase-contrast imaging in pulmonary hypertension. Br J Radiol. 2016 Jul;89(1063):20150995. doi: 10.1259/bjr.20150995. Epub 2016 Apr 6.</citation>
    <PMID>26942293</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 14, 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>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</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/NCT01725763
org study id: CMR-12-PH
nct id: NCT01725763
lead sponsor: 
has dmc: Yes
Pulmonary hypertension (PH) is a life-threatening cardiovascular disease characterized by
      pathological elevation of mean pulmonary arterial pressure (mPAP) >/= 25 mmHg at rest. mPAP <
      20 mmHg is defined as normal, values in the range between 21-24 mmHg are described as
      "borderline PH" diagnosed by right heart catheterization. Based on the etiology, PH is
      assigned to 5 groups (WHO, Data Point, 2008), whereas classification of disease is an
      important prognostic and therapy-deciding criterion.

      Cardiac magnetic resonance tomography (CMR) provides a reliable technique to estimate
      elevated mean pulmonary arterial pressure from period of existence of a vortical motion of
      blood flow in the main pulmonary artery. Vortex can be visualized in 3-dimensional vector
      field, particle trace and streamline representations and can be analysed with respect to
      vortex related measures (geometry of center, vortex formation, vorticity, propagation
      dynamics …). Furthermore T1-mapping and non-contrast enhanced lung perfusion/ventilation
      scans represent promising techniques for PH characterization.

      Aim of this explorative study is to 1. analyse PH-associated blood flow characteristics in
      the heart and the surrounding great vessels with respect to the 5 groups of PH, and 2.
      investigate the hemodynamic state of "borderline PH" compared to normal mPAP and manifest PH
      by non-contrast CMR.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: blood flow patterns
time frame: 2 years
description: fluid dynamical properties of blood flow patterns in the heart and surrounding great vessels associated with ethiology of PH
measure: myocardial magnetic relaxation times
time frame: 2 years
description: left and right ventricular myocardial T1 times associated with ethiology of PH
measure: pulmonary ventilation and perfusion
time frame: 2 years
description: pulmonary ventilation and perfusion associated with ethiology of PH
arm group label: suspected PH
arm group type: Other
description: 60 minute Cardiac MRI
intervention type: Other
intervention name: Cardiac MRI
arm group label: suspected PH
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ursula Reiter, PhD
role: Principal Investigator
affiliation: Medical Unitersity Graz, Department of Radiology, Division of General Radiology
last name: Michael Fuchsjäger, Prof. Dr.
role: Principal Investigator
affiliation: Medical Unitersity Graz, Department of Radiology, Division of General Radiology
facility: 
country: Austria
citation: Reiter U, Kovacs G, Reiter C, Krauter C, Nizhnikava V, Fuchsjager M, Olschewski H, Reiter G. MR 4D flow-based mean pulmonary arterial pressure tracking in pulmonary hypertension. Eur Radiol. 2021 Apr;31(4):1883-1893. doi: 10.1007/s00330-020-07287-6. Epub 2020 Sep 24.
PMID: 32974687
citation: Reiter U, Reiter G, Kovacs G, Stalder AF, Gulsun MA, Greiser A, Olschewski H, Fuchsjager M. Evaluation of elevated mean pulmonary arterial pressure based on magnetic resonance 4D velocity mapping: comparison of visualization techniques. PLoS One. 2013 Dec 12;8(12):e82212. doi: 10.1371/journal.pone.0082212. eCollection 2013.
PMID: 24349224
citation: Reiter G, Reiter U, Kovacs G, Olschewski H, Fuchsjager M. Blood flow vortices along the main pulmonary artery measured with MR imaging for diagnosis of pulmonary hypertension. Radiology. 2015 Apr;275(1):71-9. doi: 10.1148/radiol.14140849. Epub 2014 Nov 5.
PMID: 25372980
citation: Reiter U, Reiter G, Fuchsjager M. MR phase-contrast imaging in pulmonary hypertension. Br J Radiol. 2016 Jul;89(1063):20150995. doi: 10.1259/bjr.20150995. Epub 2016 Apr 6.
PMID: 26942293
responsible party type: Principal Investigator
investigator affiliation: Medical University of Graz
investigator full name: Ursula Reiter
investigator title: Principal Investigator
mesh term: Hypertension, Pulmonary
mesh term: Hypertension