<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/NCT03010514</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingIHLBVD2016017</org_study_id>
    <nct_id>NCT03010514</nct_id>
  </id_info>
  <brief_title>A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection</brief_title>
  <acronym>ARSGBTAAD</acronym>
  <official_title>A Chinese Registry to Determine the Genetic Risk Factors and Serumal Biomarkers for Thoracic Aortic Aneurysm/Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Institute of Heart, Lung and Blood Vessel Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Institute of Heart, Lung and Blood Vessel Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a national registry study to determine genetic risk factor and serial biomarkers of&#xD;
      thoracic aortic aneurysm/dissection&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</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>Age for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Height for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Contact information for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Past Medical History including disease history, surgical history, and family medical history</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Exon sequencing data of each participant</measure>
    <time_frame>Sequencing will be carried out in an average of 3 months after sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum biomarker screening data of each participant</measure>
    <time_frame>Screening will be carried out in an average of 3 months after sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The location of Aneurysm/Dissection</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The size of Aneurysm/Dissection</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood biochemical index：blood lipid</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood biochemical index：blood glucose</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood biochemical index：uric acid</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood biochemical index：urea</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood biochemical index：creatinine</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood biochemical index：C reactive protein</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood biochemical index：d dime</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug treatment</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgery type</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Prognosis information: all-cause death</measure>
    <time_frame>These data is collected during follow-up visit at 3/6/12 months after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Prognosis information: whether recidivation happened</measure>
    <time_frame>These data is collected during follow-up visit at 3/6/12 months after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Prognosis information including: whether other related disease happened</measure>
    <time_frame>These data is collected during follow-up visit at 3/6/12 months after discharge</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Aortic Aneurysm, Thoracic</condition>
  <condition>Aneurysm, Dissecting</condition>
  <arm_group>
    <arm_group_label>case</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable&#xD;
      cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA.&#xD;
&#xD;
      If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid&#xD;
      nitrogen.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        case group consists of patients who was diagnosed as thoracic aortic aneurysm/dissection;&#xD;
        control group is general population without aortic aneurysm/dissection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Case Inclusion Criteria:&#xD;
&#xD;
          1. Subject who was diagnosed as thoracic aortic aneurysm/dissection by CT angiography,&#xD;
             interventional angiography or vascular ultrasound;&#xD;
&#xD;
          2. Age is less than 80 years old;&#xD;
&#xD;
          3. male and non pregnancy female;&#xD;
&#xD;
          4. Subject understands study requirements aand agrees to sign an informed consent form&#xD;
             prior to any study procedures.&#xD;
&#xD;
        Case Exclusion Criteria:&#xD;
&#xD;
        Subject has one of the following:&#xD;
&#xD;
          1. Pseudoaneurysm;&#xD;
&#xD;
          2. Previous infection or trauma in the damaged part of aorta;&#xD;
&#xD;
          3. Pregnancy female;&#xD;
&#xD;
          4. Participate in other clinical trials in the last 1 months.&#xD;
&#xD;
        Control Inclusion Criteria:&#xD;
&#xD;
          1. Age and gender are matched with cases;&#xD;
&#xD;
          2. No aortic disease was detected by outpatient ultrasound;&#xD;
&#xD;
          3. No family history of cardiovascular disease;&#xD;
&#xD;
          4. Normal biochemical indicators;&#xD;
&#xD;
        Criteria for culling, shedding and suspension testing:&#xD;
&#xD;
          1. Culling: Unqualified cases and controls. Data of culled subjects can not be used for&#xD;
             statistical analysis;&#xD;
&#xD;
          2. Shedding: Subject that self withdrawal, loss to follow-up, or quitted by doctors;&#xD;
             Reasons for shedding should be indicated for each shed subject.&#xD;
&#xD;
          3. Suspension: a) The researchers found significant safety problems or wrong study&#xD;
             design; b) Researchers cannot continue clinical research due to funding or management&#xD;
             reasons; c) Director ends the study. When suspension happens, all the CRF table should&#xD;
             be reserved for future reference.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Du, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yulin Li, PHD</last_name>
    <email>lyllyl_1111@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ke-xu Yang</last_name>
      <phone>86-010-64426153</phone>
      <email>EC@anzhenGCP.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 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>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Thoracic</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/NCT03010514
org study id: BeijingIHLBVD2016017
nct id: NCT03010514
lead sponsor: 
has dmc: Yes
This is a national registry study to determine genetic risk factor and serial biomarkers of
      thoracic aortic aneurysm/dissection
observational model: Cohort
time perspective: Retrospective
measure: Age for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Gender for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Height for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Weight for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Contact information for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Past Medical History including disease history, surgical history, and family medical history
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Exon sequencing data of each participant
time frame: Sequencing will be carried out in an average of 3 months after sample recruiting
measure: Serum biomarker screening data of each participant
time frame: Screening will be carried out in an average of 3 months after sample recruiting
measure: The location of Aneurysm/Dissection
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: The size of Aneurysm/Dissection
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：blood lipid
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：blood glucose
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：uric acid
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：urea
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：creatinine
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：C reactive protein
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：d dime
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Drug treatment
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Surgery type
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Prognosis information: all-cause death
time frame: These data is collected during follow-up visit at 3/6/12 months after discharge
measure: Prognosis information: whether recidivation happened
time frame: These data is collected during follow-up visit at 3/6/12 months after discharge
measure: Prognosis information including: whether other related disease happened
time frame: These data is collected during follow-up visit at 3/6/12 months after discharge
arm group label: case
arm group label: control
If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable
      cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA.

      If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid
      nitrogen.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jie Du, PHD
role: Study Director
affiliation: Beijing Anzhen Hospital
last name: Yulin Li, PHD
email: lyllyl_1111@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Aortic Dissection
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Thoracic
sharing ipd: Undecided