Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Efficacy as measured by total number of days in hospital within 60 days of surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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
干预措施: tart cherry concentrate (Dietary Supplement)
结局指标
主要结局
Efficacy as measured by total number of days in hospital within 60 days of surgery
时间窗: 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
时间窗: 30 days
Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Patient-reported tolerability score
时间窗: One week
Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale
次要结局
- Cerebrovascular thromboembolism [stroke, TIA](30 days)
- Number of Re-hospitalization and ED visits(60 days)
- Number of Outpatient Interventions(60 days)
- Incidences of postoperative clinical events(30 days)
- Time to conversion to normal sinus rhythm(30 days)
- Heart rhythm at 30 days(30 days)
- Non-cerebrovascular thromboembolism(30 days)
- Bleeding(30 days)
- Cerebrovascular events(30 days)
- Total Costs for Hospital stay(60 days)
- Length of Hospital Stay(60 days)
- Heart rhythm at hospital discharge(30 days)
- Need for permanent pacemaker within 30 days of surgery(30 days)
研究者
Steven Bolling
Professor of Surgery
University of Michigan