Post-operative Atrial Fibrillation (POAF)
Conditions
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.
Interventions
DIETARY_SUPPLEMENTtart cherry concentrate
Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
Sponsors
University of Michigan
Cherry Marketing Institute, Dewitt MI (USA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported tolerability score | One week | Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 60 days | LOS \[Index hospitalization\] |
| Time to conversion to normal sinus rhythm | 30 days | Perioperative time to conversion to normal sinus rhythm |
| Heart rhythm at hospital discharge | 30 days | Heart rhythm at hospital discharge |
| Heart rhythm at 30 days | 30 days | Heart rhythm at 30 days |
| Need for permanent pacemaker within 30 days of surgery | 30 days | Need for permanent pacemaker within 30 days of surgery |
| Cerebrovascular thromboembolism [stroke, TIA] | 30 days | Incidences (yes/no, total number) of Cerebrovascular thromboembolism \[stroke, TIA\] |
| Non-cerebrovascular thromboembolism | 30 days | Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism |
| Bleeding | 30 days | Incidences (yes/no, total number) of Bleeding |
| Cerebrovascular events | 30 days | Incidences (yes/no, total number) of Cerebrovascular events |
| Number of Re-hospitalization and ED visits | 60 days | Number of Re-hospitalization and ED visits |
| Incidences of postoperative clinical events | 30 days | Incidences (yes/no, total number) of Non-cerebrovascular events |
| Number of Outpatient Interventions | 60 days | Number of Outpatient interventions |
| Total Costs for Hospital stay | 60 days | Costs \[incident hospital stay\] |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven F Bolling, MD
University of Michigan
Outcome results
None listed