<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/NCT04439565</url>
  </required_header>
  <id_info>
    <org_study_id>https://orcid.org/0000-0002-05</org_study_id>
    <nct_id>NCT04439565</nct_id>
  </id_info>
  <brief_title>Study on Susceptibility Genes and Pathogenic Mechanism of Non-syndromic Familial Aortic Dissection</brief_title>
  <official_title>Study on Susceptibility Genes and Pathogenic Mechanism of Non-syndromic Familial Aortic Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Medical Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Medical Association</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>
      Aortic dissection is dangerous and difficult to predict, so it is particularly important to&#xD;
      carry out early prevention, diagnosis and rational treatment for high-risk groups. The&#xD;
      related genes found in previous studies can not be detected in all patients with dissection;&#xD;
      at present, the pathogenesis of non-syndromic aortic dissection is not clear, of which about&#xD;
      20% of patients have family aggregation and have the general representative characteristics&#xD;
      of non-syndromic dissection. In this project, the peripheral blood samples of core family&#xD;
      subjects were detected by sequencing technique. analyze disease-related susceptibility genes;&#xD;
      2 determine the effect of susceptibility genes on the incidence of dissection in mice through&#xD;
      animal experiments; and 3 explore the effect of susceptibility genes on cell function at the&#xD;
      cellular level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 17, 2020</start_date>
  <completion_date type="Anticipated">July 17, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 17, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>gege</measure>
    <time_frame>2023</time_frame>
    <description>Discovery of known or unknown genes</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Aortic Dissection</condition>
  <condition>Family Research</condition>
  <condition>Aortic Dissection, Familial, With or Without Aortic Aneurysm</condition>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>movement</intervention_name>
    <description>aortic dissection or aneurysm patients this is an observation cohort study about a Non-syndromic Familial Aortic Dissection without intervention.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA is extracted from blood and preserved for a long time.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1, family members have no traumatic aortic dissection; 2, no pregnancy or tumor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family inclusion criteria: 1 at least one person in each generation of a family has&#xD;
             aortic dissection, and at least two generations of members can be included;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pedigree exclusion criteria: pedigree members have marfan syndrome, Loeys-Dietz&#xD;
             syndrome, Ehler-Danlos syndrome, aneurysm-Osteoarthritis syndrome and other syndroms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jing Zaiping, professor</last_name>
    <phone>02131161670</phone>
    <email>xueguanky@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changhaihospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Zaiping, MD</last_name>
      <phone>61670</phone>
      <email>xueguanky@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Medical Association</investigator_affiliation>
    <investigator_full_name>Zaiping Jing</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>aortic dissection</keyword>
  <keyword>pathogenesis</keyword>
  <keyword>familial inheritance</keyword>
  <keyword>susceptibility gene</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Disease Susceptibility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04439565
org study id: https://orcid.org/0000-0002-05
nct id: NCT04439565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aortic dissection is dangerous and difficult to predict, so it is particularly important to
      carry out early prevention, diagnosis and rational treatment for high-risk groups. The
      related genes found in previous studies can not be detected in all patients with dissection;
      at present, the pathogenesis of non-syndromic aortic dissection is not clear, of which about
      20% of patients have family aggregation and have the general representative characteristics
      of non-syndromic dissection. In this project, the peripheral blood samples of core family
      subjects were detected by sequencing technique. analyze disease-related susceptibility genes;
      2 determine the effect of susceptibility genes on the incidence of dissection in mice through
      animal experiments; and 3 explore the effect of susceptibility genes on cell function at the
      cellular level.
observational model: Family-Based
time perspective: Other
measure: gege
time frame: 2023
description: Discovery of known or unknown genes
intervention type: Genetic
intervention name: movement
description: aortic dissection or aneurysm patients this is an observation cohort study about a Non-syndromic Familial Aortic Dissection without intervention.
DNA is extracted from blood and preserved for a long time.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jing Zaiping, professor
phone: 02131161670
email: xueguanky@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Medical Association
investigator full name: Zaiping Jing
investigator title: professor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Dissection
mesh term: Disease Susceptibility
sharing ipd: Undecided