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/NCT05965882</url>
    </required_header>
    <id_info>
      <org_study_id>BIOMS-IHD</org_study_id>
      <nct_id>NCT05965882</nct_id>
    </id_info>
    <brief_title>A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )</brief_title>
    <official_title>A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )</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 Shanxi Medical 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 discover biomarkers for accurate classification and risk&#xD;
        assessment of ischemic heart disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to discover biomarkers for early identification, diagnosis,&#xD;
        molecular classification, and intervention based on the mechanism of ischemic heart&#xD;
        disease（IHD）. Using mass spectrometry-based metabolomics and multimodal imaging technology,&#xD;
        the study aims to further construct a new system for early risk stratification of IHD based&#xD;
        on abnormal metabolites.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 2016</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Number of hospitalizations for acute heart failure (HF)</measure>
      <time_frame>These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge</time_frame>
      <description>Unplanned emergency visits or hospitalizations leading to HF deterioration were defined as hospitalizations for HF</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Major adverse cardiovascular events (MACE)</measure>
      <time_frame>These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge</time_frame>
      <description>Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure hospitalization, recurrent myocardial infarction, stroke or ischemia-driven revascularization.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Partients with ischemic heart disease accorrding to Inclusion and exclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria :&#xD;
  &#xD;
            -  Aged 18 years or older.&#xD;
  &#xD;
            -  Previous ischemic symptoms/signs or electrocardiographic ischemic changes and.&#xD;
  &#xD;
            -  &gt;70% stenosis of at least one epicardial coronary artery on angiography or a history&#xD;
               of myocardial infarction or coronary revascularization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with acute myocardial infarction were excluded from the study.&#xD;
  &#xD;
            -  Current known inability to follow instructions or comply with follow-up procedures.&#xD;
  &#xD;
            -  Eligible patients without informed consent form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</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>The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yuan Wang, PhD</last_name>
      <phone>13910161443</phone>
      <email>wangyuan980510@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yangkai Fan, PhD</last_name>
      <phone>15010188587</phone>
      <email>fan@mail.ccmu.edu.cn</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>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ischemic heart disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT05965882
  org study id: BIOMS-IHD
  nct id: NCT05965882
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The registry study aims to discover biomarkers for accurate classification and risk
        assessment of ischemic heart disease.
  The purpose of this study is to discover biomarkers for early identification, diagnosis,
        molecular classification, and intervention based on the mechanism of ischemic heart
        disease（IHD）. Using mass spectrometry-based metabolomics and multimodal imaging technology,
        the study aims to further construct a new system for early risk stratification of IHD based
        on abnormal metabolites.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of hospitalizations for acute heart failure (HF)
  time frame: These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
  description: Unplanned emergency visits or hospitalizations leading to HF deterioration were defined as hospitalizations for HF
  measure: Major adverse cardiovascular events (MACE)
  time frame: These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
  description: Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure hospitalization, recurrent myocardial infarction, stroke or ischemia-driven revascularization.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jie Du, phD
  role: Study Director
  affiliation: The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
  last name: Yuan Wang, PhD
  phone: 13910161443
  email: wangyuan980510@163.com
  last name: Yangkai Fan, PhD
  phone: 15010188587
  email: fan@mail.ccmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  mesh term: Heart Diseases
  mesh term: Myocardial Ischemia
  mesh term: Coronary Artery Disease