<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/NCT04481542</url>
  </required_header>
  <id_info>
    <org_study_id>2019011776B0</org_study_id>
    <nct_id>NCT04481542</nct_id>
  </id_info>
  <brief_title>Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging</brief_title>
  <official_title>Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      We prospectively collected information on consecutive patients who had been evaluated using&#xD;
      4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020.&#xD;
      Patients were eligible for inclusion in the study if they had a clinical indication for CTA&#xD;
      of aortic dissections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In&#xD;
      addition, patients with poor compliance and with unstable status that prevented them from&#xD;
      lying down for the MRI protocol were excluded. Initially, 26 patients evaluated. One patient&#xD;
      was excluded due to fever at the scheduled time, and another was unable to lie down due to&#xD;
      complicated spine disease. All patients underwent CTA scan on a 64-slice multidetector&#xD;
      scanner (Somatom Sensation 64; Siemens Healthcare, Erlangen, Germany) with the intravenous&#xD;
      administration of contrast media, followed by 4D PC-MRI to assess aortic pathology&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 12, 2025</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>stroke volume</measure>
    <time_frame>5 years</time_frame>
    <description>anatomic/hemodynamic parameter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>5 years</time_frame>
    <description>diagnostic function</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>MRI</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>check MRI quality in aorta</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with aortic disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients were eligible for inclusion in the study if they had a clinical indication for CTA&#xD;
        of aortic dissections. The exclusion criteria were non-MRI-compatible ferromagnetic devices&#xD;
        and pregnancy. In addition, patients with poor compliance and with unstable status that&#xD;
        prevented them from lying down for the MRI protocol were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yao-Kuang Huang</name>
      <address>
        <city>Chiayi City</city>
        <state>Chiayi County</state>
        <zip>61362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yao-Kuang Huang</last_name>
      <phone>033186785</phone>
      <email>huang137@mac.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CVS MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</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/NCT04481542
org study id: 2019011776B0
nct id: NCT04481542
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
We prospectively collected information on consecutive patients who had been evaluated using
      4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020.
      Patients were eligible for inclusion in the study if they had a clinical indication for CTA
      of aortic dissections.
The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In
      addition, patients with poor compliance and with unstable status that prevented them from
      lying down for the MRI protocol were excluded. Initially, 26 patients evaluated. One patient
      was excluded due to fever at the scheduled time, and another was unable to lie down due to
      complicated spine disease. All patients underwent CTA scan on a 64-slice multidetector
      scanner (Somatom Sensation 64; Siemens Healthcare, Erlangen, Germany) with the intravenous
      administration of contrast media, followed by 4D PC-MRI to assess aortic pathology
observational model: Cohort
time perspective: Retrospective
measure: stroke volume
time frame: 5 years
description: anatomic/hemodynamic parameter
measure: adverse event
time frame: 5 years
description: diagnostic function
intervention type: Diagnostic Test
intervention name: MRI
description: check MRI quality in aorta
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Aortic Dissection
sharing ipd: No