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/NCT06038994</url>
    </required_header>
    <id_info>
      <org_study_id>20230901</org_study_id>
      <nct_id>NCT06038994</nct_id>
    </id_info>
    <brief_title>Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction</brief_title>
    <official_title>Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing Medical 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>
        To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial&#xD;
        infarction&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque&#xD;
        development and vulnerability in mice. However, no human data was available. In the present&#xD;
        study, patients diagnosed with acute myocardial infarction who receive coronary angiography&#xD;
        will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of&#xD;
        surem TRAF3IP2 levels with the major adverse cardiac events will be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>MACEs (major adverse cardiac events)</measure>
      <time_frame>1 year</time_frame>
      <description>MACEs were defined as a composite of cardiac death, hospitalization for myocardial infarction or heart failure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cardiac death</measure>
      <time_frame>1 year</time_frame>
      <description>and death due to cardiac reasons, such as myocardial infarction or heart failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hospitalization for myocardial infarction or heart failure</measure>
      <time_frame>1 year</time_frame>
      <description>hospitalization for myocardial infarction or heart failure</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Myocardial Infarction, Acute</condition>
    <arm_group>
      <arm_group_label>Patients with acute myocardial infarction who experienced CAG</arm_group_label>
      <description>Patients with acute myocardial infarction who experienced coronary angiography</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>This is an obvertional study, and there is no intervention.</description>
      <arm_group_label>Patients with acute myocardial infarction who experienced CAG</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        The blood sample will be collected, and the surem TRAF3IP2 levels will be measured using&#xD;
        ELASA.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All patients with acute myocardial infarction who received coronary angiography well&#xD;
          enrolled in Huai'an First People's Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with acute myocardial infarction&#xD;
  &#xD;
            2. patients received coronary angiography&#xD;
  &#xD;
            3. invasive management within 72 h of hospital admission&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. NYHA III-IV&#xD;
  &#xD;
            2. malignant tumor&#xD;
  &#xD;
            3. acute infection&#xD;
  &#xD;
            4. thyroid dysfunction&#xD;
  &#xD;
            5. Life expectancy of b1 y&#xD;
  &#xD;
            6. Unsuitable for PCI&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shuren Ma, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>NJMU</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jin Geng, MD.</last_name>
      <phone>+86-17753124846</phone>
      <email>gj885258@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Huai'an First People's Hospital</name>
        <address>
          <city>Huai'an</city>
          <state>Jiangsu</state>
          <zip>223300</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaozhong Yang, MD.</last_name>
        <phone>+8684922412</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
      <investigator_full_name>Jin Geng</investigator_full_name>
      <investigator_title>associate doctor</investigator_title>
    </responsible_party>
    <keyword>TRAF3IP2, Myocardial Infarction, Coronary angiography, MACEs</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available.</ipd_description>
    </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/NCT06038994
  org study id: 20230901
  nct id: NCT06038994
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial
        infarction
  Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque
        development and vulnerability in mice. However, no human data was available. In the present
        study, patients diagnosed with acute myocardial infarction who receive coronary angiography
        will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of
        surem TRAF3IP2 levels with the major adverse cardiac events will be evaluated.
  observational model: Case-Only
  time perspective: Prospective
  measure: MACEs (major adverse cardiac events)
  time frame: 1 year
  description: MACEs were defined as a composite of cardiac death, hospitalization for myocardial infarction or heart failure
  measure: cardiac death
  time frame: 1 year
  description: and death due to cardiac reasons, such as myocardial infarction or heart failure
  measure: hospitalization for myocardial infarction or heart failure
  time frame: 1 year
  description: hospitalization for myocardial infarction or heart failure
  arm group label: Patients with acute myocardial infarction who experienced CAG
  description: Patients with acute myocardial infarction who experienced coronary angiography
  intervention type: Other
  intervention name: No intervention
  description: This is an obvertional study, and there is no intervention.
  arm group label: Patients with acute myocardial infarction who experienced CAG
  The blood sample will be collected, and the surem TRAF3IP2 levels will be measured using
        ELASA.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Shuren Ma, MD.
  role: Principal Investigator
  affiliation: NJMU
  last name: Jin Geng, MD.
  phone: +86-17753124846
  email: gj885258@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Nanjing Medical University
  investigator full name: Jin Geng
  investigator title: associate doctor
  mesh term: Myocardial Infarction
  mesh term: Infarction
  sharing ipd: No
  ipd description: There is not a plan to make IPD available.