Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
关键词
抽象
日期
| 最后验证: | 01/31/2020 |
| 首次提交: | 01/01/2019 |
| 提交的预估入学人数: | 01/02/2019 |
| 首次发布: | 01/03/2019 |
| 上次提交的更新: | 02/24/2020 |
| 最近更新发布: | 02/25/2020 |
| 实际学习开始日期: | 02/07/2019 |
| 预计主要完成日期: | 06/14/2021 |
| 预计完成日期: | 12/29/2021 |
状况或疾病
干预/治疗
Dietary Supplement: Tart Cherry Concentrate
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 50 Years 至 50 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Patient-reported tolerability score [One week]
2. Efficacy as measured by total number of days in hospital within 60 days of surgery [60 days]
次要成果指标
1. Time to conversion to normal sinus rhythm [30 days]
2. Heart rhythm at hospital discharge [30 days]
3. Heart rhythm at 30 days [30 days]
4. Need for permanent pacemaker within 30 days of surgery [30 days]
5. Cerebrovascular thromboembolism [stroke, TIA] [30 days]
6. Non-cerebrovascular thromboembolism [30 days]
7. Bleeding [30 days]
8. Cerebrovascular events [30 days]
9. Incidences of postoperative clinical events [30 days]
10. Length of Hospital Stay [60 days]
11. Number of Re-hospitalization and ED visits [60 days]
12. Number of Outpatient Interventions [60 days]
13. Total Costs for Hospital stay [60 days]
