xml: <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/NCT05999188</url>
    </required_header>
    <id_info>
      <org_study_id>XJTU1AF2023LSK-313</org_study_id>
      <nct_id>NCT05999188</nct_id>
    </id_info>
    <brief_title>Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC)</brief_title>
    <acronym>CLASSIC</acronym>
    <official_title>Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC): a National, Multicenter, Retrospective-prospective, Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>521 Hospital of NORINCO Group</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shaanxi Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiangyang Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Henan Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>First Affiliated Hospital Xi'an Jiaotong University</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>
        This study will construct a retrospective-prospective long-term follow-up cohort and&#xD;
        management system for aortic dissection through a multicentre collaborative network. This&#xD;
        study aims to investigate the disease characteristics, progression patterns, clinical&#xD;
        features, natural course and factors affecting the disease course and prognosis of patients&#xD;
        with aortic dissection by retrospectively collecting data and prospectively enrolling&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to construct a retrospective-prospective long-term follow-up cohort and&#xD;
        management system for aortic dissection through a multicentre collaborative network. The&#xD;
        duration of the study will be divided into retrospective and prospective components. The&#xD;
        retrospective study will collect cases of aortic dissection of different aetiologies from&#xD;
        2003-2022; the prospective study is expected to collect cases of aortic dissection from&#xD;
        2022-2030. The study is expected to assess the disease characteristics, progression patterns,&#xD;
        clinical features, natural course and long-term prognosis of aortic coarctation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">December 12, 2030</completion_date>
    <primary_completion_date type="Anticipated">October 12, 2030</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>Change of post-operative survival rate</measure>
      <time_frame>3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.</time_frame>
      <description>Post-operative survival rate of patients after aortic dissection surgery in 3, 6, 9 month and 1, 2, 3, 4, 5 year. The survival situation will be assessed by telephone follow-up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of the incidence of MACCE</measure>
      <time_frame>3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.</time_frame>
      <description>Major adverse cardio-cerebrovascular events included myocardial infarction, stroke, revascularization and all-cause death. The occurrence of MACCE will be assessed by telephone follow-up and medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of any complications</measure>
      <time_frame>5 years after the surgery.</time_frame>
      <description>Any complications diagnosed by doctors. The occurrence of complications will be decided by medical records.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Aortic Dissection</condition>
    <arm_group>
      <arm_group_label>Aortic dissection group</arm_group_label>
      <description>Patients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational</intervention_name>
      <description>No interventions will be given to patients.</description>
      <arm_group_label>Aortic dissection group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, urine, faeces, other types of body fluids (e.g. pericardial fluid), surgical and&#xD;
        biopsy collected tissue specimens.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are aged 18-80 years and diagnosed with aortic dissection at any of the centre&#xD;
          can be enrolled.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-80 years;&#xD;
  &#xD;
            -  Meet diagnostic criteria for aortic dissection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years or &gt;80 years;&#xD;
  &#xD;
            -  Women who are pregnant and breastfeeding;&#xD;
  &#xD;
            -  Patients and their families refuse or are unable to sign the informed consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guoliang Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yang Yan</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guoliang Li</last_name>
      <phone>0086-029-13759982523</phone>
      <email>liguoliang_med@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yang Yan</last_name>
      <email>yangyan3@mail.xjtu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>First Affiliated Hospital of Xian Jiantong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Guoliang Li</last_name>
        <phone>008613759982523</phone>
        <email>liguoliang_med@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>aortic dissection</keyword>
    <keyword>clinical characteristics</keyword>
    <keyword>prognosis</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>
  
  
text: 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/NCT05999188
  org study id: XJTU1AF2023LSK-313
  nct id: NCT05999188
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will construct a retrospective-prospective long-term follow-up cohort and
        management system for aortic dissection through a multicentre collaborative network. This
        study aims to investigate the disease characteristics, progression patterns, clinical
        features, natural course and factors affecting the disease course and prognosis of patients
        with aortic dissection by retrospectively collecting data and prospectively enrolling
        patients.
  This study aims to construct a retrospective-prospective long-term follow-up cohort and
        management system for aortic dissection through a multicentre collaborative network. The
        duration of the study will be divided into retrospective and prospective components. The
        retrospective study will collect cases of aortic dissection of different aetiologies from
        2003-2022; the prospective study is expected to collect cases of aortic dissection from
        2022-2030. The study is expected to assess the disease characteristics, progression patterns,
        clinical features, natural course and long-term prognosis of aortic coarctation.
  observational model: Cohort
  time perspective: Other
  measure: Change of post-operative survival rate
  time frame: 3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
  description: Post-operative survival rate of patients after aortic dissection surgery in 3, 6, 9 month and 1, 2, 3, 4, 5 year. The survival situation will be assessed by telephone follow-up.
  measure: Change of the incidence of MACCE
  time frame: 3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
  description: Major adverse cardio-cerebrovascular events included myocardial infarction, stroke, revascularization and all-cause death. The occurrence of MACCE will be assessed by telephone follow-up and medical records.
  measure: Incidence of any complications
  time frame: 5 years after the surgery.
  description: Any complications diagnosed by doctors. The occurrence of complications will be decided by medical records.
  arm group label: Aortic dissection group
  description: Patients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up.
  intervention type: Other
  intervention name: Observational
  description: No interventions will be given to patients.
  arm group label: Aortic dissection group
  Blood, urine, faeces, other types of body fluids (e.g. pericardial fluid), surgical and
        biopsy collected tissue specimens.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Guoliang Li
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Yang Yan
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Guoliang Li
  phone: 0086-029-13759982523
  email: liguoliang_med@163.com
  last name: Yang Yan
  email: yangyan3@mail.xjtu.edu.cn
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Aortic Dissection
  sharing ipd: No