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/NCT05991700</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00211419</org_study_id>
      <nct_id>NCT05991700</nct_id>
    </id_info>
    <brief_title>Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation</brief_title>
    <official_title>Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>California Table Grape Commission</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery&#xD;
        and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following&#xD;
        cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of&#xD;
        POAF, however many typical anti-inflammatory medications, such as ibuprofen, are&#xD;
        contraindicated in the post cardiac surgery patient due to increased risks of bleeding. If a&#xD;
        drug was identified with anti-inflammatory properties with minimal deleterious side effects,&#xD;
        this could be broadly applied to cardiac surgery patients for the prevention of POAF.&#xD;
        Interestingly, several small trials have shown that medications that alter transcription of&#xD;
        inflammatory markers lead to decreased POAF. Furthermore, we have shown that phytochemicals,&#xD;
        such as those found in grapes, have excellent bioavailability and can affect cardiac gene&#xD;
        transcription related to inflammation. In this study, we propose to evaluate the efficacy of&#xD;
        preoperative administration of concentrated grape powder in the prevention of POAF.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>POAF-related events during initial hospital stay and within 30 days after surgery</measure>
      <time_frame>30 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II</measure>
      <time_frame>30 days</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Post-operative Atrial Fibrillation (POAF)</condition>
    <arm_group>
      <arm_group_label>Concentrated grape powder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Freeze-Dried California Table Grape</intervention_name>
      <description>Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery</description>
      <arm_group_label>Concentrated grape powder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing&#xD;
               elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR&#xD;
               patients also undergoing CABG and/or tricuspid valve repair are also eligible)&#xD;
  &#xD;
            -  In sinus rhythm (no pre-operative atrial fibrillation)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 80 years&#xD;
  &#xD;
            -  Diagnosed pre-operative chronic or paroxysmal AF&#xD;
  &#xD;
            -  Prior ablation procedure for AF&#xD;
  &#xD;
            -  Previous cardiac surgery&#xD;
  &#xD;
            -  Implanted pacemaker&#xD;
  &#xD;
            -  Active smoker&#xD;
  &#xD;
            -  Comorbidities such as congenital or cardiac re-operation&#xD;
  &#xD;
            -  Use of antiarrhythmic agents&#xD;
  &#xD;
            -  Active inflammatory or infectious disease or malignancy&#xD;
  &#xD;
            -  Diagnosed autoimmune disease&#xD;
  &#xD;
            -  Corticosteroid or other immunomodulatory or immunosuppressive medication&#xD;
  &#xD;
            -  Risk factors for POAF including low ejection fraction (EF) (EF&lt;50%), left atrial (LA)&#xD;
               dilation (LA&gt;5.0 cm), and high degree of mitral regurgitation (grade 3-4).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>China Green, BS</last_name>
      <phone>734-936-7731</phone>
      <email>chjgreen@med.umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Michigan - Michigan Medicine</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>China Green, BS</last_name>
        <phone>734-936-7731</phone>
        <email>chjgreen@med.umich.edu</email>
      </contact>
      <investigator>
        <last_name>Steven F Bolling, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Catherine Wagner, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Catherine Wagner</investigator_full_name>
      <investigator_title>House Officer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</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/NCT05991700
  org study id: HUM00211419
  nct id: NCT05991700
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery
        and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following
        cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of
        POAF, however many typical anti-inflammatory medications, such as ibuprofen, are
        contraindicated in the post cardiac surgery patient due to increased risks of bleeding. If a
        drug was identified with anti-inflammatory properties with minimal deleterious side effects,
        this could be broadly applied to cardiac surgery patients for the prevention of POAF.
        Interestingly, several small trials have shown that medications that alter transcription of
        inflammatory markers lead to decreased POAF. Furthermore, we have shown that phytochemicals,
        such as those found in grapes, have excellent bioavailability and can affect cardiac gene
        transcription related to inflammation. In this study, we propose to evaluate the efficacy of
        preoperative administration of concentrated grape powder in the prevention of POAF.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: POAF-related events during initial hospital stay and within 30 days after surgery
  time frame: 30 days
  measure: Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II
  time frame: 30 days
  arm group label: Concentrated grape powder
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Freeze-Dried California Table Grape
  description: Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery
  arm group label: Concentrated grape powder
  intervention type: Drug
  intervention name: Placebo
  description: Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 79 Years
  healthy volunteers: No
  last name: China Green, BS
  phone: 734-936-7731
  email: chjgreen@med.umich.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Catherine Wagner
  investigator title: House Officer
  mesh term: Atrial Fibrillation
  sharing ipd: No