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| Name | Class |
|---|---|
| Cherry Marketing Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tart Cherry Concentrate | Experimental | Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tart cherry concentrate | Dietary Supplement | Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery |
|
| 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 |
| 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 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven F Bolling, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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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
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| 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 |