Acute Myocardial Infarction (AMI)NCT06991283
the Impact of Transcutaneous Vagus Nerve Stimulation on Cardiovascular Events in Patients With Acute Myocardial Infarction
A study testing transcutaneous vagus nerve stimulation in people with Acute Myocardial Infarction (AMI), run by Shanghai East Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- transcutaneous vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- transcutaneous vagus nerve stimulation, Sham (no implant)
- Keywords
- acute myocardial infarcation, inflammation, vagus nerve stimulation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Separate occurrence of recurrent myocardial infarction, heart failure, ventricular arrhythmias, cardiovascular death
Measured: 3 month after the onset of AMI
Changes in left ventricular ejection fraction (EF) at 3 months.
Left ventricular ejection fraction will be calculated by cardiac echocardiography using Simpson method
Measured: 3 month after onset of AMI
Changes in BNP, IL-6, CRP and troponin-T on day 7.
Changes in BNP, IL-6, CRP and troponin-T on day 7. The changes will be calculated compared with baseline(immediate result after AMI).
Measured: Day 7 after AMI
Changes in the 6-minute walk test at 3 month
6-minute walk test will performe at Day 7 and 3 month,and changes will be calculated.
Measured: 3 months after the onset of AMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991283
- Sponsor's protocol ID
- 2025YS-063
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 27 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Transcutaneous Vagus Nerve Stimulation on Cardiovascular Events in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06991283
- Acronym / sponsor ID
- 2025YS-063
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- acute myocardial infarcation, inflammation, vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 27 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: Sham (no implant)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. |
| Stimulation Group | Experimental | Device: transcutaneous vagus nerve stimulationPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous vagus nerve stimulationThe 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 | Stimulation Group |
| 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. | Device | Control group |
Primary outcome
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.
4 secondary outcomes
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
Changes in left ventricular ejection fraction (EF) at 3 months.
Time frame: 3 month after onset of AMI
Changes in BNP, IL-6, CRP and troponin-T on day 7.
Time frame: Day 7 after AMI
Changes in the 6-minute walk test at 3 month
Time frame: 3 months after the onset of AMI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagus nerve stimulation in people with Acute Myocardial Infarction (AMI), run by Shanghai East Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhang Wu, MD (+86-021-38804518, charleswyz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of composite cardiovascular events at 3 months (time frame: 3 months after the onset of AMI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2025.