Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- late loss
研究概览
简要总结
The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.
详细描述
Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related myocardial injury, as indicated by the release of perioperative cardiac enzymes, is associated with worse patient morbidity and mortality after elective valve replacement surgery. Although the actual mechanism is still unclear, it has been shown that ischemic preconditioning is one potential strategy for reduction of myocardial injury in open heart surgery. Recently, Electro- acupuncture (EA) was proved to produced cerebral protective and antiarrhythmic effects by mimicking ischemic preconditioning. This study aims to assess whether electroacupuncture preconditioning is also effective in reducing myocardial injury in adults with acquired heart valve disease undergoing elective valve replacement surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have the indication for aortic or mitral valve replacement
- •patients would like to accept the follow-up and sign the informed consent
- •patients with heart function of NYHA I-III degree.
排除标准
- •pregnant or nursing women
- •comorbid with coronary artery disease
- •patients with heart function of NYHA IV degree
- •renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L)
- •anticipated life span < 12 months
- •enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.
结局指标
主要结局
late loss
时间窗: 12 months
次要结局
未报告次要终点
