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/NCT06033937</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1758-2</org_study_id>
      <nct_id>NCT06033937</nct_id>
    </id_info>
    <brief_title>COMPETE Cohort Study</brief_title>
    <official_title>Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Migraine attacks are episodic disorder that affects approximately 12% of the population, and&#xD;
        studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale&#xD;
        (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness&#xD;
        in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs&#xD;
        have shown negative primary results, making it unclear whether PFO occlusion is effective in&#xD;
        treating migraine. Our study is a multi-center cohort study aiming to find the correlation&#xD;
        between PFO closure and migraine attacks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>Responder rate</measure>
      <time_frame>From baseline period to 12-month treatment period</time_frame>
      <description>Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Migraine days change per month</measure>
      <time_frame>From baseline period to 12-month treatment period</time_frame>
      <description>Change in the mean number of migraine days from baseline to treatment phase.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of migraine attacks change per month</measure>
      <time_frame>From baseline period to 12-month treatment period</time_frame>
      <description>Change in the mean number of migraine attacks from baseline to treatment phase.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of complete migraine cessation</measure>
      <time_frame>From baseline period to 12-month treatment period</time_frame>
      <description>Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">242</enrollment>
    <condition>PFO - Patent Foramen Ovale</condition>
    <condition>Migraine</condition>
    <arm_group>
      <arm_group_label>Migraine Medication Group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>PFO Occlusion Group</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PFO occlusion</intervention_name>
      <description>Patients in PFO occlusion group received PFO closure using devices.</description>
      <arm_group_label>PFO Occlusion Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with PFO and migraine who met the eligibility criteria are recruited for&#xD;
          this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-65 ；&#xD;
  &#xD;
            2. Diagnosed migraine by ICHD-3&#xD;
  &#xD;
            3. History of migraine longer than 1 year, and symptoms severely disturbing daily life.&#xD;
  &#xD;
            4. TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt&#xD;
  &#xD;
            5. Willing to participant and agree to follow-ups&#xD;
  &#xD;
            6. Received at least three different types of migraine preventive drugs, the responder&#xD;
               rate of previous therapy did not receive 50%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Migraine caused by other reason&#xD;
  &#xD;
            2. Had TIA/stroke history&#xD;
  &#xD;
            3. With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.&#xD;
  &#xD;
            4. With contraindication to PFO occlusion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xiangbin Pan, MD</last_name>
      <phone>88396666</phone>
      <email>panxiangbin@fuwaihospital.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fengwen Zhang, MD</last_name>
      <phone>88396666</phone>
      <email>zhangfengwen08@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fuwai Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100028</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiangbin Pan, MD</last_name>
        <phone>88396666</phone>
        <email>panxiangbin@fuwaihospital.org</email>
      </contact>
      <contact_backup>
        <last_name>Fengwen Zhang, MD</last_name>
        <phone>88396666</phone>
        <email>zhangfengwen08@126.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
      <investigator_full_name>Pan Xiangbin</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Migraine Disorders</mesh_term>
      <mesh_term>Foramen Ovale, Patent</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/NCT06033937
  org study id: 2022-1758-2
  nct id: NCT06033937
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Migraine attacks are episodic disorder that affects approximately 12% of the population, and
        studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale
        (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness
        in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs
        have shown negative primary results, making it unclear whether PFO occlusion is effective in
        treating migraine. Our study is a multi-center cohort study aiming to find the correlation
        between PFO closure and migraine attacks.
  observational model: Cohort
  time perspective: Prospective
  measure: Responder rate
  time frame: From baseline period to 12-month treatment period
  description: Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
  measure: Migraine days change per month
  time frame: From baseline period to 12-month treatment period
  description: Change in the mean number of migraine days from baseline to treatment phase.
  measure: Number of migraine attacks change per month
  time frame: From baseline period to 12-month treatment period
  description: Change in the mean number of migraine attacks from baseline to treatment phase.
  measure: Percentage of complete migraine cessation
  time frame: From baseline period to 12-month treatment period
  description: Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase.
  arm group label: Migraine Medication Group
  arm group label: PFO Occlusion Group
  intervention type: Device
  intervention name: PFO occlusion
  description: Patients in PFO occlusion group received PFO closure using devices.
  arm group label: PFO Occlusion Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Xiangbin Pan, MD
  phone: 88396666
  email: panxiangbin@fuwaihospital.org
  last name: Fengwen Zhang, MD
  phone: 88396666
  email: zhangfengwen08@126.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
  investigator full name: Pan Xiangbin
  investigator title: Principal investigator
  mesh term: Migraine Disorders
  mesh term: Foramen Ovale, Patent