Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
Ključne riječi
Sažetak
Datumi
| Posljednja provjera: | 01/31/2020 |
| Prvo podneseno: | 01/01/2019 |
| Predviđena prijava predata: | 01/02/2019 |
| Prvo objavljeno: | 01/03/2019 |
| Zadnje ažuriranje poslato: | 02/24/2020 |
| Posljednje ažuriranje objavljeno: | 02/25/2020 |
| Stvarni datum početka studija: | 02/07/2019 |
| Procijenjeni datum primarnog završetka: | 06/14/2021 |
| Predviđeni datum završetka studije: | 12/29/2021 |
Stanje ili bolest
Intervencija / liječenje
Dietary Supplement: Tart Cherry Concentrate
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| 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 |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 50 Years To 50 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | 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 |
Ishod
Primarne mjere ishoda
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]
Sekundarne mjere ishoda
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]
