Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- POAF-related events during initial hospital stay and within 30 days after surgery
研究概览
简要总结
Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of POAF, however many typical anti-inflammatory medications, such as ibuprofen, are contraindicated in the post cardiac surgery patient due to increased risks of bleeding. If a drug was identified with anti-inflammatory properties with minimal deleterious side effects, this could be broadly applied to cardiac surgery patients for the prevention of POAF. Interestingly, several small trials have shown that medications that alter transcription of inflammatory markers lead to decreased POAF. Furthermore, we have shown that phytochemicals, such as those found in grapes, have excellent bioavailability and can affect cardiac gene transcription related to inflammation. In this study, we propose to evaluate the efficacy of preoperative administration of concentrated grape powder in the prevention of POAF.
详细描述
Voluntary recruitment hold pending approval of new protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 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)
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
- •Risk factors for POAF including low ejection fraction (EF) (EF<50%), left atrial (LA) dilation (LA>5.0 cm), and high degree of mitral regurgitation (grade 3-4).
研究组 & 干预措施
Concentrated grape powder
干预措施: Freeze-Dried California Table Grape (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
POAF-related events during initial hospital stay and within 30 days after surgery
时间窗: 30 days
Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II
时间窗: 30 days
次要结局
未报告次要终点
研究者
Steven Bolling
Professor
University of Michigan
