<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/NCT03030521</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-011</org_study_id>
    <nct_id>NCT03030521</nct_id>
  </id_info>
  <brief_title>The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection</brief_title>
  <official_title>The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Asia Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Asia Heart Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why&#xD;
      some aortic dissection are limited in extent while other aortic dissection extend&#xD;
      extensively. The investigators hypothesize that the medial layers are separated as a result&#xD;
      of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis&#xD;
      is ture, dilation is necessary to the development of aortic dissection. In this study, an in&#xD;
      vitro experiment was performed to test whether dilation is essential to the development of&#xD;
      aortic dissection.&#xD;
&#xD;
      Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart&#xD;
      Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation.&#xD;
      Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly,&#xD;
      the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner&#xD;
      surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue&#xD;
      sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of&#xD;
      the experimental group was bound by a band to restrict its dilation in the next step.&#xD;
      Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly,&#xD;
      for the experimental group, the band is removed, and the syringe is filled with red stain.&#xD;
      The mechanical test is performed again. Finally, the tissue sheet is released and cut into&#xD;
      several parts to show whether the inner and outer media layers are separated by the blue&#xD;
      stain or the red stain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanical test: the syringe's pressure will increase gradually to a target level, and&#xD;
      then decrease gradually to 0 Mpa, and this process is repeated for about 60 times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">February 24, 2017</completion_date>
  <primary_completion_date type="Actual">February 24, 2017</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>The number of patients with a positive result of the aortic delamination test</measure>
    <time_frame>1 month</time_frame>
    <description>whether the inner and outer media layers are separated by the blue stain or the red stain.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Aortic Dissection</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <description>In this group, the specimen of aortic wall is bound by a band to restrict its dilation in the fourth step of the aortic delamination test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>In this group, the specimen of aortic wall is not bound by a band to restrict its dilation in the fourth step of the aortic delamination test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>the aortic delamination test</intervention_name>
    <description>The aortic delamination test will be performed in the dissected tissue of all patient. The processes of this test has been descripted in the summary.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese adult patients with aortic repair surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with aortic repair surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the dissected aortic wall is not big enough to be cut into a 2cm by 2cm sheet after&#xD;
             routine pathological examination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhenlu Zhang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Wuhan Asia Heart Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wuhan Asia Heart Hospital</name>
      <address>
        <city>Wuhan</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>February 24, 2017</last_update_submitted>
  <last_update_submitted_qc>February 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <ipd_description>The investigators will not share participant data with other researchers.</ipd_description>
  </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/NCT03030521
org study id: 2012-P-011
nct id: NCT03030521
lead sponsor: 
has dmc: Yes
Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why
      some aortic dissection are limited in extent while other aortic dissection extend
      extensively. The investigators hypothesize that the medial layers are separated as a result
      of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis
      is ture, dilation is necessary to the development of aortic dissection. In this study, an in
      vitro experiment was performed to test whether dilation is essential to the development of
      aortic dissection.

      Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart
      Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation.
      Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly,
      the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner
      surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue
      sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of
      the experimental group was bound by a band to restrict its dilation in the next step.
      Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly,
      for the experimental group, the band is removed, and the syringe is filled with red stain.
      The mechanical test is performed again. Finally, the tissue sheet is released and cut into
      several parts to show whether the inner and outer media layers are separated by the blue
      stain or the red stain.
The mechanical test: the syringe's pressure will increase gradually to a target level, and
      then decrease gradually to 0 Mpa, and this process is repeated for about 60 times.
observational model: Cohort
time perspective: Prospective
measure: The number of patients with a positive result of the aortic delamination test
time frame: 1 month
description: whether the inner and outer media layers are separated by the blue stain or the red stain.
arm group label: experimental group
description: In this group, the specimen of aortic wall is bound by a band to restrict its dilation in the fourth step of the aortic delamination test.
arm group label: control group
description: In this group, the specimen of aortic wall is not bound by a band to restrict its dilation in the fourth step of the aortic delamination test.
intervention type: Diagnostic Test
intervention name: the aortic delamination test
description: The aortic delamination test will be performed in the dissected tissue of all patient. The processes of this test has been descripted in the summary.
arm group label: control group
arm group label: experimental group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Zhenlu Zhang, MD
role: Study Chair
affiliation: Wuhan Asia Heart Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Aortic Dissection
sharing ipd: No
ipd description: The investigators will not share participant data with other researchers.