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/NCT06001073</url>
    </required_header>
    <id_info>
      <org_study_id>XJTU1AF2023LSK-353</org_study_id>
      <nct_id>NCT06001073</nct_id>
    </id_info>
    <brief_title>Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics</brief_title>
    <acronym>PROSPECT</acronym>
    <official_title>Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): 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>Xi'an Gaoxin Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>General Hospital of Ningxia Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Affiliated Hospital of Nanchang University</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>
        The etiology and specific pathogenesis of many cardiovascular diseases such as coronary&#xD;
        atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving&#xD;
        diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the&#xD;
        prevention and treatment are hot research topics in the study of cardiovascular and&#xD;
        cerebrovascular diseases. This study intends to collect clinical data and biological specimen&#xD;
        data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and&#xD;
        exclusion criteria, and use multi-omics technology to deeply understand the pathogenic&#xD;
        mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific&#xD;
        and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to&#xD;
        construct early predictive prognostic models and provide a basis for effective treatment of&#xD;
        clinical practice in patients with cardiovascular and cerebrovascular diseases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular and cerebrovascular diseases refer to ischemic and hemorrhagic diseases of the&#xD;
        heart, brain and body tissues caused by hyperlipidemia, blood viscosity, atherosclerosis,&#xD;
        hypertension, etc. It is one of the major public health problems in the world. The etiology&#xD;
        and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis,&#xD;
        cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and&#xD;
        treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and&#xD;
        treatment are hot research topics in the study of cardiovascular and cerebrovascular&#xD;
        diseases. This study intends to collect clinical data and biological specimen data of&#xD;
        patients with cardiovascular and cerebrovascular diseases who meet the inclusion and&#xD;
        exclusion criteria, and use multi-omics technology to deeply understand the pathogenic&#xD;
        mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific&#xD;
        and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to&#xD;
        construct early predictive prognostic models and provide a basis for effective treatment of&#xD;
        clinical practice in patients with cardiovascular and cerebrovascular diseases.&#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 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2028</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>Change of MACCE</measure>
      <time_frame>Through study completion, up to 5 years.</time_frame>
      <description>Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of all-cause mortality</measure>
      <time_frame>Through study completion, up to 5 years.</time_frame>
      <description>Incidence of patients' death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of myocardial infarction</measure>
      <time_frame>Through study completion, up to 5 years.</time_frame>
      <description>Changes of serum myocardial zymogram level and ECG were used for diagnosing of myocardial infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of coronary revascularization.</measure>
      <time_frame>Through study completion, up to 5 years.</time_frame>
      <description>Incidence of percutaneous coronary intervention or coronary artery bypass grafting.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of stroke</measure>
      <time_frame>Through study completion, up to 5 years.</time_frame>
      <description>Stroke were assessed by radiologist using CT scan or other imaging test.</description>
    </secondary_outcome>
    <number_of_groups>12</number_of_groups>
    <enrollment type="Anticipated">25000</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Arrhythmias, Cardiac</condition>
    <condition>Heart Valve Diseases</condition>
    <condition>Aortic Dissection</condition>
    <condition>Heart Neoplasms</condition>
    <condition>Myocarditis</condition>
    <condition>Hypertension</condition>
    <condition>Cardiomyopathies</condition>
    <condition>Structural Heart Disease</condition>
    <condition>Ischemic Cerebrovascular Disease</condition>
    <condition>Hemorrhagic Cerebrovascular Disease</condition>
    <condition>Brain Neoplasms</condition>
    <arm_group>
      <arm_group_label>Coronary artery disease group</arm_group_label>
      <description>Diagnosis of coronary artery disease by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arrhythmia group</arm_group_label>
      <description>Diagnosis of arrhythmia by clinical guidelines. by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Heart valve disease group</arm_group_label>
      <description>Diagnosis of heart valve disease by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>aortic dissection group</arm_group_label>
      <description>Diagnosis of aortic dissection by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cardiac masses group</arm_group_label>
      <description>Diagnosis of cardiac messes by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Myocarditis group</arm_group_label>
      <description>Diagnosis of myocarditis by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hypertension group</arm_group_label>
      <description>Diagnosis of hypertension by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cardiomyopathy group</arm_group_label>
      <description>Diagnosis of cardiomyopathy by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Structural heart disease group</arm_group_label>
      <description>Diagnosis of structural heart disease by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ischemic cerebrovascular disease group</arm_group_label>
      <description>Diagnosis of ischemic cerebrovascular disease by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hemorrhagic cerebrovascular disease group</arm_group_label>
      <description>Diagnosis of hemorrhagic cerebrovascular disease by clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intracranial space occupying lesion group</arm_group_label>
      <description>Diagnosis of intracranial space occupying by clinical guidelines.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational; No Interventions were given.</intervention_name>
      <description>Observational; No Interventions were given.</description>
      <arm_group_label>Arrhythmia group</arm_group_label>
      <arm_group_label>Cardiac masses group</arm_group_label>
      <arm_group_label>Cardiomyopathy group</arm_group_label>
      <arm_group_label>Coronary artery disease group</arm_group_label>
      <arm_group_label>Heart valve disease group</arm_group_label>
      <arm_group_label>Hemorrhagic cerebrovascular disease group</arm_group_label>
      <arm_group_label>Hypertension group</arm_group_label>
      <arm_group_label>Intracranial space occupying lesion group</arm_group_label>
      <arm_group_label>Ischemic cerebrovascular disease group</arm_group_label>
      <arm_group_label>Myocarditis group</arm_group_label>
      <arm_group_label>Structural heart disease group</arm_group_label>
      <arm_group_label>aortic dissection group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, feces urine and tissues.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with cardiovascular and cerebrovascular diseases will be recruited, including&#xD;
          coronary artery disease, arrhythmia, heart valve disease, aortic dissection, cardiac&#xD;
          masses, myocarditis, hypertension, cardiomyopathy, structural heart disease, ischemic&#xD;
          cerebrovascular disease, hemorrhagic cerebrovascular disease, and intracranial space&#xD;
          occupying lesion.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are regularly visited and followed up in the appropriate patient;&#xD;
               department.&#xD;
  &#xD;
            -  All patients met at least one of the following diagnostic criteria for cardiovascular&#xD;
               and cerebrovascular diseases:&#xD;
  &#xD;
            -  coronary artery disease group;&#xD;
  &#xD;
            -  arrhythmia group;&#xD;
  &#xD;
            -  heart valve disease group;&#xD;
  &#xD;
            -  aortic dissection group;&#xD;
  &#xD;
            -  cardiac masses group;&#xD;
  &#xD;
            -  myocarditis group;&#xD;
  &#xD;
            -  hypertension group;&#xD;
  &#xD;
            -  cardiomyopathy group;&#xD;
  &#xD;
            -  structural heart disease group;&#xD;
  &#xD;
            -  ischemic cerebrovascular disease group;&#xD;
  &#xD;
            -  hemorrhagic cerebrovascular disease group;&#xD;
  &#xD;
            -  intracranial space occupying lesion group.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;3 years or &gt;80 years old;&#xD;
  &#xD;
            -  Pregnant and lactating women;&#xD;
  &#xD;
            -  The patient declined to provide informed consent to participate in the study;&#xD;
  &#xD;
            -  None of the above was met, but the patient was temporarily unable to sign the informed&#xD;
               consent form due to coma and other reasons, and no legal representative signed it&#xD;
               instead. Depending on the patient's condition, the patient may not be able to regain&#xD;
               consciousness and sign the informed consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gouliang 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 of Xian Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gouliang Li</last_name>
      <phone>13759982523</phone>
      <email>liguoliang_med@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yang Yan</last_name>
      <phone>13259882601</phone>
      <email>yangyan3@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>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 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>Cardiovascular diseases</keyword>
    <keyword>Cerebrovascular diseases</keyword>
    <keyword>Prognosis</keyword>
    <keyword>Multi-omics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Brain Neoplasms</mesh_term>
      <mesh_term>Heart Neoplasms</mesh_term>
      <mesh_term>Cerebrovascular Disorders</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Arrhythmias, Cardiac</mesh_term>
      <mesh_term>Aortic Dissection</mesh_term>
      <mesh_term>Myocarditis</mesh_term>
      <mesh_term>Heart Valve Diseases</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/NCT06001073
  org study id: XJTU1AF2023LSK-353
  nct id: NCT06001073
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The etiology and specific pathogenesis of many cardiovascular diseases such as coronary
        atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving
        diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the
        prevention and treatment are hot research topics in the study of cardiovascular and
        cerebrovascular diseases. This study intends to collect clinical data and biological specimen
        data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and
        exclusion criteria, and use multi-omics technology to deeply understand the pathogenic
        mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific
        and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to
        construct early predictive prognostic models and provide a basis for effective treatment of
        clinical practice in patients with cardiovascular and cerebrovascular diseases.
  Cardiovascular and cerebrovascular diseases refer to ischemic and hemorrhagic diseases of the
        heart, brain and body tissues caused by hyperlipidemia, blood viscosity, atherosclerosis,
        hypertension, etc. It is one of the major public health problems in the world. The etiology
        and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis,
        cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and
        treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and
        treatment are hot research topics in the study of cardiovascular and cerebrovascular
        diseases. This study intends to collect clinical data and biological specimen data of
        patients with cardiovascular and cerebrovascular diseases who meet the inclusion and
        exclusion criteria, and use multi-omics technology to deeply understand the pathogenic
        mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific
        and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to
        construct early predictive prognostic models and provide a basis for effective treatment of
        clinical practice in patients with cardiovascular and cerebrovascular diseases.
  observational model: Cohort
  time perspective: Other
  measure: Change of MACCE
  time frame: Through study completion, up to 5 years.
  description: Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.
  measure: Change of all-cause mortality
  time frame: Through study completion, up to 5 years.
  description: Incidence of patients' death from any cause.
  measure: Incidence of myocardial infarction
  time frame: Through study completion, up to 5 years.
  description: Changes of serum myocardial zymogram level and ECG were used for diagnosing of myocardial infarction.
  measure: Incidence of coronary revascularization.
  time frame: Through study completion, up to 5 years.
  description: Incidence of percutaneous coronary intervention or coronary artery bypass grafting.
  measure: Incidence of stroke
  time frame: Through study completion, up to 5 years.
  description: Stroke were assessed by radiologist using CT scan or other imaging test.
  arm group label: Coronary artery disease group
  description: Diagnosis of coronary artery disease by clinical guidelines.
  arm group label: Arrhythmia group
  description: Diagnosis of arrhythmia by clinical guidelines. by clinical guidelines.
  arm group label: Heart valve disease group
  description: Diagnosis of heart valve disease by clinical guidelines.
  arm group label: aortic dissection group
  description: Diagnosis of aortic dissection by clinical guidelines.
  arm group label: Cardiac masses group
  description: Diagnosis of cardiac messes by clinical guidelines.
  arm group label: Myocarditis group
  description: Diagnosis of myocarditis by clinical guidelines.
  arm group label: Hypertension group
  description: Diagnosis of hypertension by clinical guidelines.
  arm group label: Cardiomyopathy group
  description: Diagnosis of cardiomyopathy by clinical guidelines.
  arm group label: Structural heart disease group
  description: Diagnosis of structural heart disease by clinical guidelines.
  arm group label: Ischemic cerebrovascular disease group
  description: Diagnosis of ischemic cerebrovascular disease by clinical guidelines.
  arm group label: Hemorrhagic cerebrovascular disease group
  description: Diagnosis of hemorrhagic cerebrovascular disease by clinical guidelines.
  arm group label: Intracranial space occupying lesion group
  description: Diagnosis of intracranial space occupying by clinical guidelines.
  intervention type: Other
  intervention name: Observational; No Interventions were given.
  description: Observational; No Interventions were given.
  arm group label: Arrhythmia group
  arm group label: Cardiac masses group
  arm group label: Cardiomyopathy group
  arm group label: Coronary artery disease group
  arm group label: Heart valve disease group
  arm group label: Hemorrhagic cerebrovascular disease group
  arm group label: Hypertension group
  arm group label: Intracranial space occupying lesion group
  arm group label: Ischemic cerebrovascular disease group
  arm group label: Myocarditis group
  arm group label: Structural heart disease group
  arm group label: aortic dissection group
  Blood, feces urine and tissues.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Gouliang Li
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Yang Yan
  role: Principal Investigator
  affiliation: First Affiliated Hospital of Xian Jiaotong University
  last name: Gouliang Li
  phone: 13759982523
  email: liguoliang_med@163.com
  last name: Yang Yan
  phone: 13259882601
  email: yangyan3@xjtu.edu.cn
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Brain Neoplasms
  mesh term: Heart Neoplasms
  mesh term: Cerebrovascular Disorders
  mesh term: Coronary Artery Disease
  mesh term: Cardiomyopathies
  mesh term: Arrhythmias, Cardiac
  mesh term: Aortic Dissection
  mesh term: Myocarditis
  mesh term: Heart Valve Diseases
  sharing ipd: No