Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Study Overview
=================
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.

Official Title
-----------------
Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence

Conditions
-----------------
Post-operative Atrial Fibrillation (POAF)

Intervention / Treatment
-----------------
* Dietary Supplement: tart cherry concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tart Cherry Concentrate<br>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<br>* Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported tolerability score | Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale | One week | 
| Efficacy as measured by total number of days in hospital within 60 days of surgery | Total number of days in hospital within 60 days of the index surgery | 60 days | 
| Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation | Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to conversion to normal sinus rhythm | Perioperative time to conversion to normal sinus rhythm | 30 days | 
| Heart rhythm at hospital discharge | Heart rhythm at hospital discharge | 30 days | 
| Heart rhythm at 30 days | Heart rhythm at 30 days | 30 days | 
| Need for permanent pacemaker within 30 days of surgery | Need for permanent pacemaker within 30 days of surgery | 30 days | 
| Cerebrovascular thromboembolism [stroke, TIA] | Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA] | 30 days | 
| Non-cerebrovascular thromboembolism | Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism | 30 days | 
| Bleeding | Incidences (yes/no, total number) of Bleeding | 30 days | 
| Cerebrovascular events | Incidences (yes/no, total number) of Cerebrovascular events | 30 days | 
| Incidences of postoperative clinical events | Incidences (yes/no, total number) of Non-cerebrovascular events | 30 days | 
| Length of Hospital Stay | LOS [Index hospitalization] | 60 days | 
| Number of Re-hospitalization and ED visits | Number of Re-hospitalization and ED visits | 60 days | 
| Number of Outpatient Interventions | Number of Outpatient interventions | 60 days | 
| Total Costs for Hospital stay | Costs [incident hospital stay] | 60 days |