<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/NCT03793465</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00145800</org_study_id>
    <nct_id>NCT03793465</nct_id>
  </id_info>
  <brief_title>Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence</brief_title>
  <official_title>Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cherry Marketing Institute, Dewitt MI (USA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related&#xD;
      clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Consumption - 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-reported tolerability score</measure>
    <time_frame>One week</time_frame>
    <description>Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as measured by total number of days in hospital within 60 days of surgery</measure>
    <time_frame>60 days</time_frame>
    <description>Total number of days in hospital within 60 days of the index surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation</measure>
    <time_frame>30 days</time_frame>
    <description>Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to conversion to normal sinus rhythm</measure>
    <time_frame>30 days</time_frame>
    <description>Perioperative time to conversion to normal sinus rhythm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rhythm at hospital discharge</measure>
    <time_frame>30 days</time_frame>
    <description>Heart rhythm at hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rhythm at 30 days</measure>
    <time_frame>30 days</time_frame>
    <description>Heart rhythm at 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for permanent pacemaker within 30 days of surgery</measure>
    <time_frame>30 days</time_frame>
    <description>Need for permanent pacemaker within 30 days of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular thromboembolism [stroke, TIA]</measure>
    <time_frame>30 days</time_frame>
    <description>Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-cerebrovascular thromboembolism</measure>
    <time_frame>30 days</time_frame>
    <description>Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>Incidences (yes/no, total number) of Bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular events</measure>
    <time_frame>30 days</time_frame>
    <description>Incidences (yes/no, total number) of Cerebrovascular events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidences of postoperative clinical events</measure>
    <time_frame>30 days</time_frame>
    <description>Incidences (yes/no, total number) of Non-cerebrovascular events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>60 days</time_frame>
    <description>LOS [Index hospitalization]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Re-hospitalization and ED visits</measure>
    <time_frame>60 days</time_frame>
    <description>Number of Re-hospitalization and ED visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Outpatient Interventions</measure>
    <time_frame>60 days</time_frame>
    <description>Number of Outpatient interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Costs for Hospital stay</measure>
    <time_frame>60 days</time_frame>
    <description>Costs [incident hospital stay]</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Post-operative Atrial Fibrillation (POAF)</condition>
  <arm_group>
    <arm_group_label>Tart Cherry Concentrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>tart cherry concentrate</intervention_name>
    <description>Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery</description>
    <arm_group_label>Tart Cherry Concentrate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 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;
          2. In sinus rhythm (no pre-operative atrial fibrillation, no hx of AF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 80 years&#xD;
&#xD;
          2. Diagnosed pre-operative chronic or paroxysmal AF&#xD;
&#xD;
          3. Prior ablation procedure for AF&#xD;
&#xD;
          4. Previous cardiac surgery&#xD;
&#xD;
          5. Implanted pacemaker&#xD;
&#xD;
          6. Active smoker&#xD;
&#xD;
          7. Comorbidities such as congenital or cardiac re-operation&#xD;
&#xD;
          8. Use of antiarrhythmic agents&#xD;
&#xD;
          9. Active inflammatory or infectious disease or malignancy&#xD;
&#xD;
         10. Diagnosed autoimmune disease&#xD;
&#xD;
         11. Corticosteroid or other immunomodulatory or immunosuppressive medication&#xD;
&#xD;
         12. Known sensitivity to sorbitol&#xD;
&#xD;
         13. Known gastric sensitivity to acidic juices like orange juice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven F Bolling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <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</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>China Green</last_name>
      <phone>734-936-7731</phone>
      <email>chjgreen@med.umich.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Steven Bolling</investigator_full_name>
    <investigator_title>Professor of Surgery</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>


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/NCT03793465
org study id: HUM00145800
nct id: NCT03793465
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related
      clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Consumption - 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
primary purpose: Prevention
masking: None (Open Label)
measure: Patient-reported tolerability score
time frame: One week
description: Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale
measure: Efficacy as measured by total number of days in hospital within 60 days of surgery
time frame: 60 days
description: Total number of days in hospital within 60 days of the index surgery
measure: Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
time frame: 30 days
description: Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
measure: Time to conversion to normal sinus rhythm
time frame: 30 days
description: Perioperative time to conversion to normal sinus rhythm
measure: Heart rhythm at hospital discharge
time frame: 30 days
description: Heart rhythm at hospital discharge
measure: Heart rhythm at 30 days
time frame: 30 days
description: Heart rhythm at 30 days
measure: Need for permanent pacemaker within 30 days of surgery
time frame: 30 days
description: Need for permanent pacemaker within 30 days of surgery
measure: Cerebrovascular thromboembolism [stroke, TIA]
time frame: 30 days
description: Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]
measure: Non-cerebrovascular thromboembolism
time frame: 30 days
description: Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism
measure: Bleeding
time frame: 30 days
description: Incidences (yes/no, total number) of Bleeding
measure: Cerebrovascular events
time frame: 30 days
description: Incidences (yes/no, total number) of Cerebrovascular events
measure: Incidences of postoperative clinical events
time frame: 30 days
description: Incidences (yes/no, total number) of Non-cerebrovascular events
measure: Length of Hospital Stay
time frame: 60 days
description: LOS [Index hospitalization]
measure: Number of Re-hospitalization and ED visits
time frame: 60 days
description: Number of Re-hospitalization and ED visits
measure: Number of Outpatient Interventions
time frame: 60 days
description: Number of Outpatient interventions
measure: Total Costs for Hospital stay
time frame: 60 days
description: Costs [incident hospital stay]
arm group label: Tart Cherry Concentrate
arm group type: Experimental
description: Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days
intervention type: Dietary Supplement
intervention name: tart cherry concentrate
description: Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
arm group label: Tart Cherry Concentrate
criteria: 
gender: All
minimum age: 50 Years
maximum age: 79 Years
healthy volunteers: No
last name: Steven F Bolling, MD
role: Principal Investigator
affiliation: University of Michigan
last name: China Green, BS
phone: 734-936-7731
email: chjgreen@med.umich.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Steven Bolling
investigator title: Professor of Surgery
mesh term: Atrial Fibrillation
sharing ipd: No