<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/NCT03780738</url>
  </required_header>
  <id_info>
    <org_study_id>2018GDSRMvalidation</org_study_id>
    <nct_id>NCT03780738</nct_id>
  </id_info>
  <brief_title>A Validation Study of The Relationship Between ALDH2 and Aortic Dissection</brief_title>
  <acronym>VaRALAD</acronym>
  <official_title>A Validation Study of The Relationship Between ALDH2 and Aortic Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qilu Hospital of Shandong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic&#xD;
      dissection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with different ALDH2 genotype</measure>
    <time_frame>1-30 days after samples collected</time_frame>
    <description>DNA was extracted from venous blood;genomic DNA underwent PCR amplification; finally, PCR products were purified and directly sequenced by Invitrogen Corp or Biosune Corp.Then ALDH2 genotype was distinguished depend on a G-to-A missense mutation on exon 12 of ALDH2 gene.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Aortic Dissection</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Chinese Han people to do physical examination in physical examination center of Guangdong Provincial People's Hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aortic dissection</arm_group_label>
    <description>Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      4 ml vein blood samples were collected from aortic dissection or controls in tubes containing&#xD;
      EDTA. The samples would be centrifuged and saved in a -80℃ ultra-low temperature&#xD;
      refrigerator.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with aortic dissection in Guangdong Provincial People's Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's&#xD;
             Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aortic dissection based on trauma, connective tissue diseases and pregnancy&#xD;
&#xD;
          -  Patients with tumor&#xD;
&#xD;
          -  Patients with no written consensus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiao Li</last_name>
    <phone>+8618560088301</phone>
    <email>jfm3145496@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guanzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Xiao</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic dissection</keyword>
  <keyword>Aldehyde dehydrogenase 2 polymorphism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</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/NCT03780738
org study id: 2018GDSRMvalidation
nct id: NCT03780738
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic
      dissection.
observational model: Case-Control
time perspective: Prospective
measure: Number of patients with different ALDH2 genotype
time frame: 1-30 days after samples collected
description: DNA was extracted from venous blood;genomic DNA underwent PCR amplification; finally, PCR products were purified and directly sequenced by Invitrogen Corp or Biosune Corp.Then ALDH2 genotype was distinguished depend on a G-to-A missense mutation on exon 12 of ALDH2 gene.
arm group label: Control
description: Chinese Han people to do physical examination in physical examination center of Guangdong Provincial People's Hospital
arm group label: Aortic dissection
description: Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital
4 ml vein blood samples were collected from aortic dissection or controls in tubes containing
      EDTA. The samples would be centrifuged and saved in a -80℃ ultra-low temperature
      refrigerator.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xiao Li
phone: +8618560088301
email: jfm3145496@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Aortic Dissection