<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/NCT04431336</url>
  </required_header>
  <id_info>
    <org_study_id>https://orcid.org/0000-0002-04</org_study_id>
    <nct_id>NCT04431336</nct_id>
  </id_info>
  <brief_title>Young Patient With Aortic Dissection or Aneurysm: A Prospective Observational Cohort Study</brief_title>
  <official_title>Clinical Characters, Treatment and Prognosis of the Young Patient With Aortic Dissection or Aneurysm: A Prospective Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Medical Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 or aneurysm is unusual in young patients, and frequently associated with&#xD;
      unusual presentations. However studies about this area is scarce. Besides, the treatment&#xD;
      option is not clare. The prognosis of this cohort is also unclear.&#xD;
&#xD;
      The goal of this study was to better understand the characters, treatment option and&#xD;
      prognosis of young patient with aortic dissection or aneurysm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To understand the clinical characteristics, treatment options and prognosis of aortic&#xD;
      dissection or aneurysm in young people，the study plan will include young people younger (≤50&#xD;
      years) with aortic dissection or aneurysm from 2020.6. Then collect their clinical data and&#xD;
      conduct follow-up studies, in order to understand younger aortic dissection or aneurysm&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 5, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</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>Clinical features of young aortic dissection and aneurysm patients</measure>
    <time_frame>before December 2021</time_frame>
    <description>Collecting clinical data, such as basic information, blood biochemical information and imaging informatio to describe the characteristics of young people.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Aortic Aneurysm and Dissection</condition>
  <arm_group>
    <arm_group_label>younger aortic dissection or aneurysm patients</arm_group_label>
    <description>this is an observation cohort study about younger aortic dissection or aneurysm patients without intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>movement</intervention_name>
    <description>movement</description>
    <arm_group_label>younger aortic dissection or aneurysm patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      To explore pathogenic genes 5m peripheral blood was extracted for whole genome sequencing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        young patients aged less than 50 years old and had aortic dissection or aneurysm&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  young patients with aortic dissection or aneurysm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aortic dissection or aneurysm due to traumatic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zaiping MD Jing, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vascular surgery, Changhai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zaiping MD Jing, professor</last_name>
    <phone>02131161670</phone>
    <email>xueguanky@163.com</email>
  </overall_contact>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/14975480/?from_single_result=Characterizing+the+Young+Patient+With+Aortic+Dissection%3A+Results+From+the+International+Registry+of+Aortic+Dissection+%28IRAD%29&amp;solr_messages=%7B%22messages%22%3A+%5B%22Custom+filter+IF%3A5-10+is+ignored+because+its+expression+exceeds+4000+characters.%22%2C+%22Custom+filter+IF%3A3-5+is+ignored+because+its+expression+exceeds+4000+characters.%22%2C+%22Custom+filter+IF%3A%3E10+is+ignored+because+its+expression+exceeds+4000+characters.%22%2C+%22Custom+filter+IF%3A2-3+is+ignored+because+its+expression+exceeds+4000+characters.%22%5D%7D</url>
    <description>Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD).</description>
  </link>
  <reference>
    <citation>Januzzi JL, Isselbacher EM, Fattori R, Cooper JV, Smith DE, Fang J, Eagle KA, Mehta RH, Nienaber CA, Pape LA; International Registry of Aortic Dissection (IRAD). Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD). J Am Coll Cardiol. 2004 Feb 18;43(4):665-9. doi: 10.1016/j.jacc.2003.08.054.</citation>
    <PMID>14975480</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 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>
  <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>
  </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/NCT04431336
org study id: https://orcid.org/0000-0002-04
nct id: NCT04431336
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aortic dissection or aneurysm is unusual in young patients, and frequently associated with
      unusual presentations. However studies about this area is scarce. Besides, the treatment
      option is not clare. The prognosis of this cohort is also unclear.

      The goal of this study was to better understand the characters, treatment option and
      prognosis of young patient with aortic dissection or aneurysm.
To understand the clinical characteristics, treatment options and prognosis of aortic
      dissection or aneurysm in young people，the study plan will include young people younger (≤50
      years) with aortic dissection or aneurysm from 2020.6. Then collect their clinical data and
      conduct follow-up studies, in order to understand younger aortic dissection or aneurysm
      patients.
observational model: Cohort
time perspective: Prospective
measure: Clinical features of young aortic dissection and aneurysm patients
time frame: before December 2021
description: Collecting clinical data, such as basic information, blood biochemical information and imaging informatio to describe the characteristics of young people.
arm group label: younger aortic dissection or aneurysm patients
description: this is an observation cohort study about younger aortic dissection or aneurysm patients without intervention.
intervention type: Behavioral
intervention name: movement
description: movement
arm group label: younger aortic dissection or aneurysm patients
To explore pathogenic genes 5m peripheral blood was extracted for whole genome sequencing.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 50 Years
healthy volunteers: No
last name: Zaiping MD Jing, Professor
role: Principal Investigator
affiliation: Vascular surgery, Changhai Hospital
last name: Zaiping MD Jing, professor
phone: 02131161670
email: xueguanky@163.com
url: https://pubmed.ncbi.nlm.nih.gov/14975480/?from_single_result=Characterizing+the+Young+Patient+With+Aortic+Dissection%3A+Results+From+the+International+Registry+of+Aortic+Dissection+%28IRAD%29&solr_messages=%7B%22messages%22%3A+%5B%22Custom+filter+IF%3A5-10+is+ignored+because+its+expression+exceeds+4000+characters.%22%2C+%22Custom+filter+IF%3A3-5+is+ignored+because+its+expression+exceeds+4000+characters.%22%2C+%22Custom+filter+IF%3A%3E10+is+ignored+because+its+expression+exceeds+4000+characters.%22%2C+%22Custom+filter+IF%3A2-3+is+ignored+because+its+expression+exceeds+4000+characters.%22%5D%7D
description: Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD).
citation: Januzzi JL, Isselbacher EM, Fattori R, Cooper JV, Smith DE, Fang J, Eagle KA, Mehta RH, Nienaber CA, Pape LA; International Registry of Aortic Dissection (IRAD). Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD). J Am Coll Cardiol. 2004 Feb 18;43(4):665-9. doi: 10.1016/j.jacc.2003.08.054.
PMID: 14975480
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
sharing ipd: Undecided