Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03793465
• Collaborator: Cherry Marketing Institute, Dewitt MI (USA) (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 47.8
• Patients Per Site Per Month: 1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• 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 surgerySingle 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: Feb 8, 2019
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient-reported tolerability score [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 [60 days]

   Total number of days in hospital within 60 days of the index surgery

3. Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation [30 days]

   Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation

Secondary Outcome Measures

1. Time to conversion to normal sinus rhythm [30 days]

   Perioperative time to conversion to normal sinus rhythm

2. Heart rhythm at hospital discharge [30 days]

   Heart rhythm at hospital discharge

3. Heart rhythm at 30 days [30 days]

   Heart rhythm at 30 days

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

   Need for permanent pacemaker within 30 days of surgery

5. Cerebrovascular thromboembolism [stroke, TIA] [30 days]

   Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]

6. Non-cerebrovascular thromboembolism [30 days]

   Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism

7. Bleeding [30 days]

   Incidences (yes/no, total number) of Bleeding

8. Cerebrovascular events [30 days]

   Incidences (yes/no, total number) of Cerebrovascular events

9. Incidences of postoperative clinical events [30 days]

   Incidences (yes/no, total number) of Non-cerebrovascular events

10. Length of Hospital Stay [60 days]

    LOS [Index hospitalization]

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

    Number of Re-hospitalization and ED visits

12. Number of Outpatient Interventions [60 days]

    Number of Outpatient interventions

13. Total Costs for Hospital stay [60 days]

    Costs [incident hospital stay]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• Cherry Marketing Institute, Dewitt MI (USA)

Investigators

• Principal Investigator: Steven F Bolling, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven Bolling, Professor of Surgery, University of Michigan
• ClinicalTrials.gov Identifier: NCT03793465
• Other Study ID Numbers: HUM00145800
• First Posted: Jan 4, 2019
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Mar 14, 2022