The Impact of Transcutaneous Vagus Nerve Stimulation on Cardiovascular Events in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 278
- 主要终点
- The occurrence of composite cardiovascular events at 3 months
研究概览
简要总结
The acute mortality rate of acute myocardial infarction (AMI) reduced significantly due to emergency reperfusion and subsequent treatment strategies. However, it remains a major cause of disability and death globally. Recent studies have shown that systemic inflammation is associated with infarct size and adverse clinical outcomes after myocardial infarction. Therefore, attenuating the inflammatory response may be a therapeutic target for acute coronary syndromes and improve clinical outcomes. Preclinical and clinical data indicate that vagus nerve stimulation (VNS) plays an important role in reducing the inflammatory burden and improving myocardial ischemia. However, more clinical evidence is needed to elucidate the role of VNS in patients with acute myocardial infarction and its impact on cardiovascular events. Therefore, this study aims to investigate the effect of vagal nerve modulation intervention through a prospective, randomized controlled clinical research method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Inclusion Criteria**
- •Age between 18 and 80 years old (including 18 and 80 years old).
- •Patients with acute myocardial infarction who have undergone revascularization of the culprit vessel within 24 hours of onset.
- •Willing to participate in this study and have signed the informed consent form.
排除标准
- •Hemodynamically unstable, with cardiogenic shock, requiring medication to maintain blood pressure and heart rate.
- •Baseline systolic blood pressure <90 mmHg or diastolic blood pressure <40 mmHg.
- •Average heart rate under monitoring <50 beats per minute.
- •Patients with II or III degree atrioventricular (AV) block or sick sinus syndrome who have not had a permanent pacemaker implanted.
- •Baseline (before the use of antiarrhythmic drugs) QTc interval ≥500 ms, PR interval >280 ms.
- •Patients who are participating in other clinical studies.
- •Other reasons deemed by the investigator as unsuitable for participation in this study.
研究组 & 干预措施
Control group
Patients in this arm will receive standard care according to the guidelines after AMI. Vagus nerve stimulation is delivered through a transcutaneous electrical nerve stimulation device by attaching an ear clip to the tragus. But no stimulation will be delivered.
干预措施: Sham (no implant) (Device)
Stimulation Group
Patients in this arm will receive standard care according to the guidelines after AMI. Vagus nerve stimulation is delivered through a transcutaneous electrical nerve stimulation device by attaching an ear clip to the tragus. The stimulation will be performed twice daily, each session lasting for half an hour. The stimulation times are fixed between 07:00-09:00 in the morning and 19:00-21:00 in the evening, with an interval of 12 hours between the two sessions. The device is set with a pulse width of 200 microseconds and a pulse frequency of 20 hertz. The stimulation intensity is individually adjusted to above the perception threshold and below the discomfort level of 1 milliampere.
干预措施: transcutaneous vagus nerve stimulation (Device)
结局指标
主要结局
The occurrence of composite cardiovascular events at 3 months
时间窗: 3 months after the onset of AMI
The composite cardiovascular events including recurrent myocardial infarction，acute heart failure, ventricular arrhythmia(ventricular tachycardia,flutter and fibrillation), cardiovascular death.
次要结局
- Changes in left ventricular ejection fraction (EF) at 3 months.(3 month after onset of AMI)
- Changes in BNP, IL-6, CRP and troponin-T on day 7.(Day 7 after AMI)
- Changes in the 6-minute walk test at 3 month(3 months after the onset of AMI)
- The occurrence of recurrent myocardial infarction, acute heart failure, ventricular arrhythmias, embolic events, and death at 3 months.(3 month after the onset of AMI)