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NCT Number: NCT06991283

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

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.

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Key information

Conditions

Acute Myocardial Infarction (AMI) Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**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.

**Exclusion Criteria**

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The occurrence of composite cardiovascular events at 3 months

    Time frame: 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.

Secondary outcomes

  1. The occurrence of recurrent myocardial infarction, acute heart failure, ventricular arrhythmias, embolic events, and death at 3 months.

    Time frame: 3 month after the onset of AMI

    Separate occurrence of recurrent myocardial infarction, heart failure, ventricular arrhythmias, cardiovascular death

  2. Changes in left ventricular ejection fraction (EF) at 3 months.

    Time frame: 3 month after onset of AMI

    Left ventricular ejection fraction will be calculated by cardiac echocardiography using Simpson method

  3. Changes in BNP, IL-6, CRP and troponin-T on day 7.

    Time frame: Day 7 after AMI

    Changes in BNP, IL-6, CRP and troponin-T on day 7. The changes will be calculated compared with baseline(immediate result after AMI).

  4. Changes in the 6-minute walk test at 3 month

    Time frame: 3 months after the onset of AMI

    6-minute walk test will performe at Day 7 and 3 month,and changes will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Yizhang Wu, MD

CONTACT

[email protected]

+86-021-38804518

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 27, 2025
Registry last updated
May 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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