EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Variation of cardiac output
研究概览
简要总结
The objective of the EpiCANS study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (SNAC) directly at the epicardial level in humans during heart surgery.
Proof of concept study
详细描述
Isolated stimulation of the parasympathetic system induces a protective effect on long-term cardiac remodeling, but at the cost of inhibiting the sympathetic system. The role of the sympathetic system is to increase cardiac output in cases of acute heart failure.
Electrical stimulation of the cardiac plexus directly at the level of the heart allows simultaneous stimulation of the sympathetic and parasympathetic systems, whose complementary and not automatically antagonistic role is now recognized. Thus, direct stimulation of the plexus would optimize cardiac function in the short and long term by instantly improving cardiac output and decreasing pulmonary resistance as described in dogs by Kobayashi et al.
The objective of the EpiCANS study is to evaluate this technique in humans during cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Scheduled for elective cardiac surgery for valvular or coronary surgery
- •Having received written and oral information about the protocol and having signed a written informed consent
- •Affiliated or beneficiary of a social security plan
排除标准
- •Patient with an indication for cardiac surgery:
- •Urgent or semi-urgent
- •Aortic surgery
- •Heart transplantation
- •Mechanical circulatory assistance
- •Patients who have already undergone cardiac surgery
- •Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors, persons unable to express their consent, persons hospitalized for a different reason
结局指标
主要结局
Variation of cardiac output
时间窗: 15 min
Cardiac output (milliliter per minute) before and after stimulation
次要结局
- Adverses events(10 days)
- Variation of central venous pressure(15 min)
- Presence of atrial fibrillation(15 min)
- Variation of pulmonary artery pressure(15 min)
- Variation of aortic pressure(15 min)
- Variation of Cardiac rythm(15 min)