A Multicenter Randomized Controlled Clinical Study of Preoperative Glycosylated Hemoglobin Control Strategies on the Effectiveness of Cox-Maze IV Procedure for Atrial Fibrillation During Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Rate of atrial fibrillation recurrence
研究概览
简要总结
In recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. How to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. Glycosylated hemoglobin (HbA1c) is the product of a non-enzymatic reaction in which hemoglobin in red blood cells is combined with sugars in the serum (mainly glucose). The purpose of this multicenter, randomized controlled study is to compare the effects of different glycosylated hemoglobin control strategies on the effectiveness of Cox-Maze IV procedure for atrial fibrillation during cardiac surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Elective cardiac surgery
- •A clear diagnosis of diabetes mellitus, and HbA1c ≥ 7.5% at the time of initial diagnosis and treatment
- •Preoperative combination of persistent or long-term persistent atrial fibrillation
排除标准
- •Emergency surgery or limited-term surgery
- •Previous cardiac surgery
- •Left atrial diameter > 65 mm
- •Serum creatine > 1.8 mg/dL
- •Previous severe liver disease
- •Pregnant or planning to become pregnant
- •Have a malignant tumor
结局指标
主要结局
Rate of atrial fibrillation recurrence
时间窗: one year post operative
Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds
次要结局
- All-cause Mortality(one year post operative)
- Rate of atrial fibrillation recurrence(6 months post operative)
研究者
Kun Hua
Deputy Chief Surgeon
Beijing Anzhen Hospital