Status:
ACTIVE_NOT_RECRUITING
Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Cherry Marketing Institute, Dewitt MI (USA)
Conditions:
Post-operative Atrial Fibrillation (POAF)
Eligibility:
All Genders
50-79 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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)
- In sinus rhythm (no pre-operative atrial fibrillation, no hx of AF)
Exclusion
- Age ≥ 80 years
- Diagnosed pre-operative chronic or paroxysmal AF
- Prior ablation procedure for AF
- Previous cardiac surgery
- Implanted pacemaker
- Active smoker
- Comorbidities such as congenital or cardiac re-operation
- Use of antiarrhythmic agents
- Active inflammatory or infectious disease or malignancy
- Diagnosed autoimmune disease
- Corticosteroid or other immunomodulatory or immunosuppressive medication
- Known sensitivity to sorbitol
- Known gastric sensitivity to acidic juices like orange juice
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03793465
Start Date
February 8 2019
End Date
January 1 2026
Last Update
January 10 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109