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Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

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ClinicalTrials.gov Identifier: NCT03793465
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Cherry Marketing Institute, Dewitt MI (USA)
Information provided by (Responsible Party):
Steven Bolling, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-operative Atrial Fibrillation (POAF) Dietary Supplement: tart cherry concentrate Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tart Cherry Concentrate
Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days
Dietary Supplement: tart cherry concentrate
Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery




Primary Outcome Measures :
  1. Patient-reported tolerability score [ Time Frame: One week ]
    Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale

  2. Efficacy as measured by total number of days in hospital within 60 days of surgery [ Time Frame: 60 days ]
    Total number of days in hospital within 60 days of the index surgery


Secondary Outcome Measures :
  1. Time to conversion to normal sinus rhythm [ Time Frame: 30 days ]
    Perioperative time to conversion to normal sinus rhythm

  2. Heart rhythm at hospital discharge [ Time Frame: 30 days ]
    Heart rhythm at hospital discharge

  3. Heart rhythm at 30 days [ Time Frame: 30 days ]
    Heart rhythm at 30 days

  4. Need for permanent pacemaker within 30 days of surgery [ Time Frame: 30 days ]
    Need for permanent pacemaker within 30 days of surgery

  5. Cerebrovascular thromboembolism [stroke, TIA] [ Time Frame: 30 days ]
    Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]

  6. Non-cerebrovascular thromboembolism [ Time Frame: 30 days ]
    Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism

  7. Bleeding [ Time Frame: 30 days ]
    Incidences (yes/no, total number) of Bleeding

  8. Cerebrovascular events [ Time Frame: 30 days ]
    Incidences (yes/no, total number) of Cerebrovascular events

  9. Incidences of postoperative clinical events [ Time Frame: 30 days ]
    Incidences (yes/no, total number) of Non-cerebrovascular events

  10. Length of Hospital Stay [ Time Frame: 60 days ]
    LOS [Index hospitalization]

  11. Number of Re-hospitalization and ED visits [ Time Frame: 60 days ]
    Number of Re-hospitalization and ED visits

  12. Number of Outpatient Interventions [ Time Frame: 60 days ]
    Number of Outpatient interventions

  13. Total Costs for Hospital stay [ Time Frame: 60 days ]
    Costs [incident hospital stay]



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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible)
  2. In sinus rhythm (no pre-operative atrial fibrillation, no hx of AF)

Exclusion Criteria:

  1. Age ≥ 80 years
  2. Diagnosed pre-operative chronic or paroxysmal AF
  3. Prior ablation procedure for AF
  4. Previous cardiac surgery
  5. Implanted pacemaker
  6. Active smoker
  7. Comorbidities such as congenital or cardiac re-operation
  8. Use of antiarrhythmic agents
  9. Active inflammatory or infectious disease or malignancy
  10. Diagnosed autoimmune disease
  11. Corticosteroid or other immunomodulatory or immunosuppressive medication
  12. Known sensitivity to sorbitol
  13. Known gastric sensitivity to acidic juices like orange juice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793465


Contacts
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Contact: Nicole Shuler, RN 734-232-4297 gervais@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nicole Shuler, RN    734-232-4297    gervais@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Cherry Marketing Institute, Dewitt MI (USA)

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Responsible Party: Steven Bolling, Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT03793465     History of Changes
Other Study ID Numbers: HUM00145800
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes