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/NCT05965375</url>
    </required_header>
    <id_info>
      <org_study_id>XJTU1AF2023LSK-171</org_study_id>
      <nct_id>NCT05965375</nct_id>
    </id_info>
    <brief_title>Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias</brief_title>
    <acronym>FUTURE</acronym>
    <official_title>Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias (FUTURE): an Investigator-initiated, 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>521 Hospital of NORINCO Group</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shaanxi Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiangyang Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Henan Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>First Affiliated Hospital Xi'an Jiaotong 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>
        The investigation of biomarkers for immune status and metabolic state, as well as host&#xD;
        microbiota composition, in patients with ventricular arrhythmias before and after&#xD;
        radiofrequency ablation, can provide new insights for specific and personalized treatment.&#xD;
        This can help establish early prediction and prognosis models and provide a basis for&#xD;
        clinically effective diagnosis and treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Abnormal immune and metabolic states can lead to the occurrence of various systemic diseases,&#xD;
        including the development of cardiovascular diseases through multiple mechanisms. On the&#xD;
        other hand, various diseases can also feedback and regulate the immune and metabolic systems.&#xD;
        However, currently there is no research on the impact of immune and metabolic states on&#xD;
        ventricular arrhythmia. Exploring the biomarker characteristics and risk stratification of&#xD;
        patients with ventricular arrhythmias undergoing radiofrequency ablation before and after the&#xD;
        procedure can provide new insights for specific and personalized treatment. It can establish&#xD;
        early prediction and prognostic models, providing evidence for clinically effective diagnosis&#xD;
        and treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2027</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 in the incidence of MACCE</measure>
      <time_frame>3,6 months,1,3,5 years after enrollment.</time_frame>
      <description>Major adverse cardiovascular and cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of myocardial infarction</measure>
      <time_frame>3,6 months,1,3,5 years after enrollment.</time_frame>
      <description>Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of stroke</measure>
      <time_frame>3,6 months,1,3,5 years after enrollment.</time_frame>
      <description>Stroke diagnosed by clinical doctors will be assessed from the medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of vessel revascularization</measure>
      <time_frame>3,6 months,1,3,5 years after enrollment.</time_frame>
      <description>Vessel revascularization assessed by clinical doctors will be assessed from the medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of all-cause death</measure>
      <time_frame>3,6 months,1,3,5 years after enrollment.</time_frame>
      <description>All-cause death diagnosed by clinical doctors will be assessed from the medical records.</description>
    </secondary_outcome>
    <number_of_groups>5</number_of_groups>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Ventricular Arrythmia</condition>
    <arm_group>
      <arm_group_label>Occasional premature ventricular contractions group</arm_group_label>
      <description>Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Occasional PVCs refer to PVCs that occur less than 6 times per minute.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Frequent premature ventricular contractions group</arm_group_label>
      <description>Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Frequent PVCs refer to PVCs that occur more than 6 times per minute.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Short runs of ventricular tachycardia group</arm_group_label>
      <description>Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Short runs of ventricular tachycardia refer to three or more consecutive PVCs that occur within 30 seconds.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sustained ventricular tachycardia group</arm_group_label>
      <description>Sustained ventricular tachycardia (VT) is defined as ventricular arrhythmia that lasts for at least 30 seconds and has a heart rate exceeding 100 bpm, or requires termination before 30 seconds due to hemodynamic instability.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ventricular fibrillation group</arm_group_label>
      <description>Ventricular fibrillation refers to the complete disappearance of QRS waves, ST segments, and T waves in the ECG, replaced by different shapes, varying amplitudes, and extremely irregular ventricular fibrillation waves.</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>Frequent premature ventricular contractions group</arm_group_label>
      <arm_group_label>Occasional premature ventricular contractions group</arm_group_label>
      <arm_group_label>Short runs of ventricular tachycardia group</arm_group_label>
      <arm_group_label>Sustained ventricular tachycardia group</arm_group_label>
      <arm_group_label>Ventricular fibrillation group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, feces and urine.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with ventricular premature beats, ventricular tachycardia, or ventricular&#xD;
          fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with ventricular premature beats, ventricular tachycardia, or ventricular&#xD;
               fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 or &gt;80 years old;&#xD;
  &#xD;
            -  Patients with autoimmune diseases or immune deficiencies, or those who have used&#xD;
               immunosuppressive or immune modulating agents in the past 3 months;&#xD;
  &#xD;
            -  Platelet count &lt;100×10^9/L or functional platelet defects;&#xD;
  &#xD;
            -  Congenital or acquired coagulation or bleeding disorders;&#xD;
  &#xD;
            -  Patients with a history of organ transplantation or are preparing to receive organ&#xD;
               transplantation;&#xD;
  &#xD;
            -  Unwilling to sign an informed consent or cooperate with the examination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guoliang Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Chaofeng Sun</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guoliang Li</last_name>
      <phone>+8613759982523</phone>
      <email>liguoliang_med@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chaofeng Sun</last_name>
      <email>cfsun1@mail.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>July 2023</verification_date>
    <study_first_submitted>July 6, 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>Ventricular Arrhythmia</keyword>
    <keyword>Prognosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arrhythmias, Cardiac</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/NCT05965375
  org study id: XJTU1AF2023LSK-171
  nct id: NCT05965375
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The investigation of biomarkers for immune status and metabolic state, as well as host
        microbiota composition, in patients with ventricular arrhythmias before and after
        radiofrequency ablation, can provide new insights for specific and personalized treatment.
        This can help establish early prediction and prognosis models and provide a basis for
        clinically effective diagnosis and treatment.
  Abnormal immune and metabolic states can lead to the occurrence of various systemic diseases,
        including the development of cardiovascular diseases through multiple mechanisms. On the
        other hand, various diseases can also feedback and regulate the immune and metabolic systems.
        However, currently there is no research on the impact of immune and metabolic states on
        ventricular arrhythmia. Exploring the biomarker characteristics and risk stratification of
        patients with ventricular arrhythmias undergoing radiofrequency ablation before and after the
        procedure can provide new insights for specific and personalized treatment. It can establish
        early prediction and prognostic models, providing evidence for clinically effective diagnosis
        and treatment.
  observational model: Cohort
  time perspective: Other
  measure: Change in the incidence of MACCE
  time frame: 3,6 months,1,3,5 years after enrollment.
  description: Major adverse cardiovascular and cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.
  measure: Change in the incidence of myocardial infarction
  time frame: 3,6 months,1,3,5 years after enrollment.
  description: Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records.
  measure: Change in the incidence of stroke
  time frame: 3,6 months,1,3,5 years after enrollment.
  description: Stroke diagnosed by clinical doctors will be assessed from the medical records.
  measure: Change in the incidence of vessel revascularization
  time frame: 3,6 months,1,3,5 years after enrollment.
  description: Vessel revascularization assessed by clinical doctors will be assessed from the medical records.
  measure: Change in the incidence of all-cause death
  time frame: 3,6 months,1,3,5 years after enrollment.
  description: All-cause death diagnosed by clinical doctors will be assessed from the medical records.
  arm group label: Occasional premature ventricular contractions group
  description: Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Occasional PVCs refer to PVCs that occur less than 6 times per minute.
  arm group label: Frequent premature ventricular contractions group
  description: Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Frequent PVCs refer to PVCs that occur more than 6 times per minute.
  arm group label: Short runs of ventricular tachycardia group
  description: Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Short runs of ventricular tachycardia refer to three or more consecutive PVCs that occur within 30 seconds.
  arm group label: Sustained ventricular tachycardia group
  description: Sustained ventricular tachycardia (VT) is defined as ventricular arrhythmia that lasts for at least 30 seconds and has a heart rate exceeding 100 bpm, or requires termination before 30 seconds due to hemodynamic instability.
  arm group label: Ventricular fibrillation group
  description: Ventricular fibrillation refers to the complete disappearance of QRS waves, ST segments, and T waves in the ECG, replaced by different shapes, varying amplitudes, and extremely irregular ventricular fibrillation waves.
  intervention type: Other
  intervention name: Observational; No Interventions were given.
  description: Observational; No Interventions were given.
  arm group label: Frequent premature ventricular contractions group
  arm group label: Occasional premature ventricular contractions group
  arm group label: Short runs of ventricular tachycardia group
  arm group label: Sustained ventricular tachycardia group
  arm group label: Ventricular fibrillation group
  Blood, feces and urine.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Guoliang Li
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Chaofeng Sun
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Guoliang Li
  phone: +8613759982523
  email: liguoliang_med@163.com
  last name: Chaofeng Sun
  email: cfsun1@mail.xjtu.edu.cn
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Arrhythmias, Cardiac