NCT06991283

the Impact of Transcutaneous Vagus Nerve Stimulation on Cardiovascular Events in Patients With Acute Myocardial Infarction

The Impact of Transcutaneous Vagus Nerve Stimulation on Cardiovascular Events in Patients With Acute Myocardial Infarction

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Myocardial Infarction (AMI)

Interventions

Type	Name	Description
DEVICE	transcutaneous vagus nerve stimulation	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.
DEVICE	Sham (no implant)	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. The sham 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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-06-01
• Completion: 2028-10-01
• First posted: 2025-05-27
• Last updated: 2025-05-27