<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/NCT03233087</url>
  </required_header>
  <id_info>
    <org_study_id>DPANDA</org_study_id>
    <nct_id>NCT03233087</nct_id>
  </id_info>
  <brief_title>Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen(DPANDA) Study</brief_title>
  <official_title>Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Institute of Heart, Lung and Blood Vessel Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Luhe Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Institute of Heart, Lung and Blood Vessel Diseases</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 registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic&#xD;
      aneurysm/aortic dissection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to investigate the role of candidate biomarkers in the diagnosis and prognosis&#xD;
      of AA and AD. In the diagnosis part, we begin with a discovery phase where individually&#xD;
      matched case-control study. Patients within each disease outcomes (i.e. AD, AMI, PE, AA&#xD;
      without AD and healthy controls) are age and sex matched and retrospectively included.In the&#xD;
      prognosis part of the study, patients with confirmed AA and AD are enrolled. The primary&#xD;
      outcome is the all-cause mortality based on the death certificates. The secondary outcome is&#xD;
      the in-hospital mortality according to the patients'medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dignosis of each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 6 month after the sample recruiting</time_frame>
    <description>Patients with Aneurysm/Dissection had image information from ultrasound cardiograms and computed tomography to confirm the final diagnosis.&#xD;
AMI if they had chest pain lasting &gt;20 min, diagnostic serial ECG changes comprising new pathological Q waves or ST-segment and T-wave changes, and a plasma creatine kinase-MB elevation greater than twice the normal level or cardiac troponin I (cTnI) level greater than 0.1 ng/mL.&#xD;
Diagnosis of PE was confirmed by positive spiral computed tomography or pulmonary angiography, a high probability on ventilation perfusion scintigraphy, or a proximal deep vein thrombosis documented on compression ultrasonography or angiography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prognosis of each participant</measure>
    <time_frame>These data is collected from the cases' medical record or during follow-up visit at 2-4 years after discharge.</time_frame>
    <description>Prognosis information including all-cause mortality and in-hospital mortality.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Aortic Aneurysm</condition>
  <condition>Aortic Dissection</condition>
  <arm_group>
    <arm_group_label>Top third of subjects based levels of selected biomarker.</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Middle third of subjects based levels of selected biomarker.</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Bottom third ofsubjects based levels of selected biomarker.</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        These cohorts consist of patients who was diagnosed as thoracic aortic aneurysm/dissection&#xD;
        or initial suspicion of having thoracic aortic aneurysm/dissection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Retrospective&#xD;
&#xD;
          -  All patients who were referred to the surgical service for evaluation and management&#xD;
             of aortic dissection were included.&#xD;
&#xD;
        Perspective&#xD;
&#xD;
          -  Patients with initial suspicion of having AAD were perspectively enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Retrospective&#xD;
&#xD;
          -  Patients who received packed red blood cells, whole blood, or platelets less than 10&#xD;
             days before the blood sample was taken;&#xD;
&#xD;
          -  Patients with aortic trauma, pseudo aneurysm, history of heart failure, renal&#xD;
             dysfunction, severe pulmonary diseases, or active cancer;&#xD;
&#xD;
          -  Patients who entered the hospital for checkups after surgery.&#xD;
&#xD;
        Perspective&#xD;
&#xD;
          -  Patients in whom there is little or no suspicion of a life-threatening disease;&#xD;
&#xD;
          -  Patients with confirmed acute myocardial infarction,angina or pulmonary embolism&#xD;
&#xD;
          -  The symptoms were clearly not related to AD (e.g. pleurisy, pneumonia, acute abdominal&#xD;
             diseases).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Yuan Wang, PhD</last_name>
    <phone>86-010-64456721</phone>
    <email>wangyuan980510@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xue Wang, MD</last_name>
    <phone>+86 010-64456721</phone>
    <email>snowlove_@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan WANG, PhD</last_name>
      <phone>86-010-64456169</phone>
      <email>wangyuan980510@163.com</email>
    </contact>
    <investigator>
      <last_name>Jie DU, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</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>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <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/NCT03233087
org study id: DPANDA
nct id: NCT03233087
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic
      aneurysm/aortic dissection.
The study aims to investigate the role of candidate biomarkers in the diagnosis and prognosis
      of AA and AD. In the diagnosis part, we begin with a discovery phase where individually
      matched case-control study. Patients within each disease outcomes (i.e. AD, AMI, PE, AA
      without AD and healthy controls) are age and sex matched and retrospectively included.In the
      prognosis part of the study, patients with confirmed AA and AD are enrolled. The primary
      outcome is the all-cause mortality based on the death certificates. The secondary outcome is
      the in-hospital mortality according to the patients'medical records.
observational model: Cohort
time perspective: Other
measure: Dignosis of each participant
time frame: These data is collected from the cases' medical record in an average of 6 month after the sample recruiting
description: Patients with Aneurysm/Dissection had image information from ultrasound cardiograms and computed tomography to confirm the final diagnosis.
AMI if they had chest pain lasting >20 min, diagnostic serial ECG changes comprising new pathological Q waves or ST-segment and T-wave changes, and a plasma creatine kinase-MB elevation greater than twice the normal level or cardiac troponin I (cTnI) level greater than 0.1 ng/mL.
Diagnosis of PE was confirmed by positive spiral computed tomography or pulmonary angiography, a high probability on ventilation perfusion scintigraphy, or a proximal deep vein thrombosis documented on compression ultrasonography or angiography.
measure: Prognosis of each participant
time frame: These data is collected from the cases' medical record or during follow-up visit at 2-4 years after discharge.
description: Prognosis information including all-cause mortality and in-hospital mortality.
arm group label: Top third of subjects based levels of selected biomarker.
arm group label: Middle third of subjects based levels of selected biomarker.
arm group label: Bottom third ofsubjects based levels of selected biomarker.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Yuan Wang, PhD
phone: 86-010-64456721
email: wangyuan980510@163.com
last name: Xue Wang, MD
phone: +86 010-64456721
email: snowlove_@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Dissection