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/NCT06033495</url>
    </required_header>
    <id_info>
      <org_study_id>657796</org_study_id>
      <nct_id>NCT06033495</nct_id>
    </id_info>
    <brief_title>Myocardial Ischemia After Coronary Sinus Reduction Stent Implantation</brief_title>
    <acronym>MICS-Reduce</acronym>
    <official_title>Myocardial Ischemia by 15O-H2O PET/CT in Patients With Coronary Artery Disease and Refractory Angina - Evaluation of the Coronary Sinus Reduction Stent Method</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oslo University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Oslo University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <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>
        Chronic angina pectoris refractory to medical and revascularization therapies is a disabling&#xD;
        medical condition and a major public health problem. Patients with refractory angina have&#xD;
        limited treatment options. One proposed therapy modality is transcatheter implantation of a&#xD;
        reduction stent in the coronary sinus. Coronary sinus reduction stents have been shown to&#xD;
        reduce angina burden considerably and to improve quality of life. The reduction stent is&#xD;
        assumed to increase myocardial perfusion and reduce myocardial ischemia, but the mechanism of&#xD;
        action is poorly understood.&#xD;
  &#xD;
        The aim of this project is to assess the myocardial ischemia burden in patients with&#xD;
        refractory angina who are undergoing a transcatheter coronary sinus reducer procedure. This&#xD;
        is a clinical non-randomized self-controlled cohort study with blinded outcome adjudication&#xD;
        for changes in myocardial perfusion. Patients with refractory angina will be systematically&#xD;
        examined before implantation of the coronary sinus reduction stent and after 6 months. The&#xD;
        primary outcome, changes in myocardial perfusion on the gold standard 15O-H2O PET/CT will be&#xD;
        evaluated on blinded perfusion scans where the stent is invisible. To provide context to the&#xD;
        findings, we will also evaluate whether changes in myocardial ischemia are associated with&#xD;
        less angina and better cardiac function parameters. Effects of stent implantation on angina&#xD;
        symptoms and quality of life could be affected by a placebo effect.&#xD;
  &#xD;
        Treatment options for patients with refractory angina is needed, and results from the present&#xD;
        study will explore if coronary sinus reduction stents are improving myocardial ischemia in&#xD;
        this patient group. Signs of improved objective perfusion will inspire confidence in the&#xD;
        method.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Myocardial ischemia</measure>
      <time_frame>6 months</time_frame>
      <description>Change in myocardial flow reserve on 15O-H2O PET/CT</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in angina burden</measure>
      <time_frame>6 months</time_frame>
      <description>Seattle angina questionnaire score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>6 months</time_frame>
      <description>Kansas City Cardiomyopathy Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in exercise capacity</measure>
      <time_frame>6 months</time_frame>
      <description>Maximum oxygen extraction on cardiopulmonary exercise test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in coronary physiology</measure>
      <time_frame>6 months</time_frame>
      <description>Invasive assessment of mmyocardial microcirculation</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Angina Pectoris</condition>
    <arm_group>
      <arm_group_label>Patients with refractory angina undergoing coronary sinus reduction stent implantation</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Coronary sinus reduction stent</intervention_name>
      <description>Percutaneous stent implantation to reduce the dimension of the coronary sinus</description>
      <arm_group_label>Patients with refractory angina undergoing coronary sinus reduction stent implantation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with coronary artery disease and refractory angina who are under clinical care are&#xD;
          informed and screened for participation if consent is provided.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Coronary artery disease and refractory angina&#xD;
  &#xD;
            -  Clinical indication for coronary sinus reduction stent implantation&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  Anticipated compliance with protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ineligibility for coronary sinus reduction stent implantation&#xD;
  &#xD;
            -  Lack of informed consent&#xD;
  &#xD;
            -  Not expected to comply with protocol&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Øyvind H Lie</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oslo University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Øyvind Lie, MD, PhD</last_name>
      <phone>+4793429011</phone>
      <email>oyvlie@gmail.com</email>
    </overall_contact>
    <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>Oslo University Hospital</investigator_affiliation>
      <investigator_full_name>Øyvind Lie</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Angina Pectoris</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>We aim to share data upon request from other academic investigators, but await EC approval</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/NCT06033495
  org study id: 657796
  nct id: NCT06033495
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Chronic angina pectoris refractory to medical and revascularization therapies is a disabling
        medical condition and a major public health problem. Patients with refractory angina have
        limited treatment options. One proposed therapy modality is transcatheter implantation of a
        reduction stent in the coronary sinus. Coronary sinus reduction stents have been shown to
        reduce angina burden considerably and to improve quality of life. The reduction stent is
        assumed to increase myocardial perfusion and reduce myocardial ischemia, but the mechanism of
        action is poorly understood.
  
        The aim of this project is to assess the myocardial ischemia burden in patients with
        refractory angina who are undergoing a transcatheter coronary sinus reducer procedure. This
        is a clinical non-randomized self-controlled cohort study with blinded outcome adjudication
        for changes in myocardial perfusion. Patients with refractory angina will be systematically
        examined before implantation of the coronary sinus reduction stent and after 6 months. The
        primary outcome, changes in myocardial perfusion on the gold standard 15O-H2O PET/CT will be
        evaluated on blinded perfusion scans where the stent is invisible. To provide context to the
        findings, we will also evaluate whether changes in myocardial ischemia are associated with
        less angina and better cardiac function parameters. Effects of stent implantation on angina
        symptoms and quality of life could be affected by a placebo effect.
  
        Treatment options for patients with refractory angina is needed, and results from the present
        study will explore if coronary sinus reduction stents are improving myocardial ischemia in
        this patient group. Signs of improved objective perfusion will inspire confidence in the
        method.
  observational model: Cohort
  time perspective: Prospective
  measure: Myocardial ischemia
  time frame: 6 months
  description: Change in myocardial flow reserve on 15O-H2O PET/CT
  measure: Change in angina burden
  time frame: 6 months
  description: Seattle angina questionnaire score
  measure: Change in quality of life
  time frame: 6 months
  description: Kansas City Cardiomyopathy Questionnaire
  measure: Change in exercise capacity
  time frame: 6 months
  description: Maximum oxygen extraction on cardiopulmonary exercise test
  measure: Change in coronary physiology
  time frame: 6 months
  description: Invasive assessment of mmyocardial microcirculation
  arm group label: Patients with refractory angina undergoing coronary sinus reduction stent implantation
  intervention type: Device
  intervention name: Coronary sinus reduction stent
  description: Percutaneous stent implantation to reduce the dimension of the coronary sinus
  arm group label: Patients with refractory angina undergoing coronary sinus reduction stent implantation
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Øyvind H Lie
  role: Principal Investigator
  affiliation: Oslo University Hospital
  last name: Øyvind Lie, MD, PhD
  phone: +4793429011
  email: oyvlie@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Oslo University Hospital
  investigator full name: Øyvind Lie
  investigator title: MD, PhD
  mesh term: Angina Pectoris
  mesh term: Myocardial Ischemia
  mesh term: Coronary Artery Disease
  mesh term: Ischemia
  sharing ipd: Undecided
  ipd description: We aim to share data upon request from other academic investigators, but await EC approval