Clinical trial NCT06991283: the Impact of Transcutaneous Vagus Nerve Stimulation on Cardiovascular Events in Patients With Acute Myocardial Infarction
Official title: The Impact of Transcutaneous Vagus Nerve Stimulation on Cardiovascular Events in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction (AMI)
Keywords: acute myocardial infarcation
inflammation
vagus nerve stimulation
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2025-05-27
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: \*\*Inclusion Criteria\*\*

1. Age between 18 and 80 years old (including 18 and 80 years old).
2. Patients with acute myocardial infarction who have undergone revascularization of the culprit vessel within 24 hours of onset.
3. Willing to participate in this study and have signed the informed consent form.

\*\*Exclusion Criteria\*\*

1. Hemodynamically unstable, with cardiogenic shock, requiring medication to maintain blood pressure and heart rate.
2. Baseline systolic blood pressure \<90 mmHg or diastolic blood pressure \<40 mmHg.
3. Average heart rate under monitoring \<50 beats per minute.
4. Patients with II or III degree atrioventricular (AV) block or sick sinus syndrome who have not had a permanent pacemaker implanted.
5. Baseline (before the use of antiarrhythmic drugs) QTc interval ≥500 ms, PR interval \>280 ms.
6. Patients who are participating in other clinical studies.
7. Other reasons deemed by the investigator as unsuitable for participation in this study.

Primary outcomes:
measure: The occurrence of composite cardiovascular events at 3 months
timeFrame: 3 months after the onset of AMI
Secondary outcomes:
measure: The occurrence of recurrent myocardial infarction, acute heart failure, ventricular arrhythmias, embolic events, and death at 3 months.
timeFrame: 3 month after the onset of AMI
measure: Changes in left ventricular ejection fraction (EF) at 3 months.
timeFrame: 3 month after onset of AMI
measure: Changes in BNP, IL-6, CRP and troponin-T on day 7.
timeFrame: Day 7 after AMI
measure: Changes in the 6-minute walk test at 3 month
timeFrame: 3 months after the onset of AMI
Other outcomes:
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Study officials:
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