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

NCT06991283 | Not Yet Recruiting DMC

• 1 other identifier: 2025YS-063
• Study Type: interventional
• Target: 278
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

acute myocardial infarcation; inflammation; vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

• The occurrence of composite cardiovascular events at 3 months

  The composite cardiovascular events including recurrent myocardial infarction，acute heart failure, ventricular arrhythmia(ventricular tachycardia,flutter and fibrillation), cardiovascular death.

  3 months after the onset of AMI

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

Control group

SHAM COMPARATOR

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.

Device: Sham (no implant)

Stimulation Group

EXPERIMENTAL

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.

Device: transcutaneous vagus nerve stimulation

Interventions

transcutaneous vagus nerve stimulation DEVICE

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.

Stimulation Group

Sham (no implant) DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yizhang Wu, MD

CONTACT

+86-021-38804518; charleswyz@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 27, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 27, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share