Vagus Nerve StimulationNCT05992259
Auricular Vagus Stimulation and STEMI
A study testing TENS in people with Vagus Nerve Stimulation and Acute Coronary Syndrome, run by Bakulev Scientific Center of Cardiovascular Surgery at 1 site in Russia.
Trial summary
At the moment, the invasive strategy for the infarct-associated coronary artery in patients with ST-segment elevation myocardial infarction (STEMI) necessary to save the myocardium and reduce the size of the necrosis zone remains the leading one. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Vagus Nerve Stimulation, Acute Coronary Syndrome, Ischemia Reperfusion Injury
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with STEMI who have signed an informed voluntary consent to participate in the study;
- primary myocardial infarction;
- treatment in the first 12 hours from the onset of pain syndrome;
- primary PCI.
Who cannot join
- acute heart failure III-IV;
- bradyarrhythmias;
- atrial fibrillation/flutter at the time of switching on;
- Thrombolytic therapy at the prehospital stage;
- a history of myocardial infarction;
- PCI/coronary artery bypass grafting (CABG) in the anamnesis.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Scientific Research Institute Ochapovsky Regional Clinical Hospital
Krasnodar
About this study
Official title: Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction
At the moment, the invasive strategy for the infarct-associated coronary artery in patients with ST-segment elevation myocardial infarction (STEMI) necessary to save the myocardium and reduce the size of the necrosis zone remains the leading one. However, despite the high efficiency of providing medical care to patients with acute coronary syndrome (ACS), there remains a high mortality and disability of this group of patients. In this regard, the search for new drug and non-drug strategies for the treatment of patients with ACS is actively continuing. Over the past decade, it has been shown that transcutaneous vagus nerve stimulation (TENS) has a cardioprotective effect both in chronic heart failure and in coronary heart disease, improves cardiac function, prevents reperfusion injury, weakens myocardial remodeling, increases the effectiveness of defibrillation and reduces the size of a heart attack. One of the methods of noninvasive stimulation of the afferent fibers of the vagus nerve is percutaneous electrical stimulation of the auricular branch of the vagus nerve. However, further studies are needed to determine whether stimulation of the tragus can improve the long-term clinical outcome in this cohort of patients.
Read the detailed description
ACS is a combined concept for such life-threatening conditions as acute myocardial infarction (AMI) and unstable angina, which are exacerbations of coronary heart disease. However, despite the high effectiveness of the invasive treatment strategy, there remains a high mortality and disability of this group of patients. One of the reasons for this problem is reperfusion injury of the myocardium during revascularization, since reperfusion itself causes myocardial damage, known as Myocardial Ischemia Reperfusion Injury (MIRI). Every year, new data from experimental studies and small clinical trials appear, confirming the concept that MIRI makes a big contribution to the final size of a heart attack and cardiac myocardial function. Currently, there is no specific treatment aimed at MIRI in patients with STEMI. Thus, new treatment methods are needed that can reduce MIRI in revascularized patients. In the course of small clinical studies, it was shown that against the background of vagus nerve stimulation, a significant decrease in heart rate occurs, inflammatory processes and cellular apoptosis are suppressed, left ventricular remodeling decreases and myocardial contractile function improves. Also, a significant decrease in MIRI is demonstrated with percutaneous stimulation of the vagus nerve in the acute period of myocardial infarction. The data of the first clinical trial with VNS in patients with STEMI were published in 2017 (doi:10.1016/j.jcin.2017.04.036). This experimental study increases the likelihood that this noninvasive therapy can be used to treat patients with STEMI who are undergoing primary percutaneous coronary intervention (PCI). New studies are needed to prove the safety and effectiveness of vagus nerve stimulation in patients with STEMI.
- Being tested
- TENS
- Keywords
- auricular stimulation, auricular vagus nerve stimulation, transcutaneous vagus nerve stimulation (TENS), vagus nerve stimulation (VNS), acute coronary syndrome, myocardial ischemia reperfusion injury, ST-segment elevation myocardial infarction, coronary heart disease, acute myocardial infarction, mortality, atrial fibrillation
- Medical subject headings
- Acute Coronary Syndrome, Reperfusion Injury, ST Elevation Myocardial Infarction, Coronary Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | It will be performed attached to the tragus of the left ear. Receives: Device: TENS |
| Sham TENS | Sham comparator | It will be performed attached to the earlobe of the left ear. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
The number of patients who died in the hospital.
Measured: From date of randomization until the date of death from any cause, assessed up to 14 days.
30-day mortality
The number of patients who died within 30 days from the development of myocardial infarction.
Measured: From date of randomization until the date of death from any cause, assessed up to 30 days.
Secondary outcomes (1)
Number of participants with non-lethal events.
The main hospital non-lethal events (Pulmonary edema, Cardiogenic shock, Cardiac arrhythmias: Atrial fibrillation, Ventricular tachycardia/fibrillation, Accelerated idioventricular rhythm/Atrioventricular block II, III).
Measured: From the date of randomization to the date of any of the listed events, assessed up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Sep 2022
- Primary completion30 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve StimulationStudies 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
- Model description
- 1:1 randomization of active stimulation vs. sham stimulation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
- Sponsor type
- Other government
- Collaborators
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
- Responsible party
- Principal investigator, Vladimir A Shvartz, MD, Bakulev Scientific Center of Cardiovascular Surgery
- Investigators
- Vladimir Shvartz, MD, DM, Principal investigator, Bakoulev Scientific Center for Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992259
- Sponsor's protocol ID
- #12
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kruchinova S, Gendugova M, Namitokov A, Sokolskaya M, Gilevich I, Tatarintseva Z, Karibova M, Danilov V, Simakin N, Shvartz E, Kosmacheva E, Shvartz V. Low-Frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve in Patients with ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. J Clin Med. 2025 Mar 10;14(6):1866. doi: 10.3390/jcm14061866.
PubMed 40142674
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05992259
- Acronym / sponsor ID
- #12
- Keywords
- auricular stimulation, auricular vagus nerve stimulation, transcutaneous vagus nerve stimulation (TENS), vagus nerve stimulation (VNS), acute coronary syndrome, myocardial ischemia reperfusion injury, ST-segment elevation myocardial infarction, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular SurgeryOther government
- Collaborators
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 15 Aug 2023 (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.
At the moment, the invasive strategy for the infarct-associated coronary artery in patients with ST-segment elevation myocardial infarction (STEMI) necessary to save the myocardium and reduce the size of the necrosis zone remains the leading one. However, despite the high efficiency of providing medical care to patients with acute coronary syndrome (ACS), there remains a high mortality and disability of this group of patients. In this regard, the search for new drug and non-drug strategies for the treatment of patients with ACS is actively continuing. Over the past decade, it has been shown that transcutaneous vagus nerve stimulation (TENS) has a cardioprotective effect both in chronic heart failure and in coronary heart disease, improves cardiac function, prevents reperfusion injury, weakens myocardial remodeling, increases the effectiveness of defibrillation and reduces the size of a heart attack. One of the methods of noninvasive stimulation of the afferent fibers of the vagus nerve is percutaneous electrical stimulation of the auricular branch of the vagus nerve. However, further studies are needed to determine whether stimulation of the tragus can improve the long-term clinical outcome in this cohort of patients.
Detailed description
ACS is a combined concept for such life-threatening conditions as acute myocardial infarction (AMI) and unstable angina, which are exacerbations of coronary heart disease. However, despite the high effectiveness of the invasive treatment strategy, there remains a high mortality and disability of this group of patients. One of the reasons for this problem is reperfusion injury of the myocardium during revascularization, since reperfusion itself causes myocardial damage, known as Myocardial Ischemia Reperfusion Injury (MIRI). Every year, new data from experimental studies and small clinical trials appear, confirming the concept that MIRI makes a big contribution to the final size of a heart attack and cardiac myocardial function. Currently, there is no specific treatment aimed at MIRI in patients with STEMI. Thus, new treatment methods are needed that can reduce MIRI in revascularized patients. In the course of small clinical studies, it was shown that against the background of vagus nerve stimulation, a significant decrease in heart rate occurs, inflammatory processes and cellular apoptosis are suppressed, left ventricular remodeling decreases and myocardial contractile function improves. Also, a significant decrease in MIRI is demonstrated with percutaneous stimulation of the vagus nerve in the acute period of myocardial infarction. The data of the first clinical trial with VNS in patients with STEMI were published in 2017 (doi:10.1016/j.jcin.2017.04.036). This experimental study increases the likelihood that this noninvasive therapy can be used to treat patients with STEMI who are undergoing primary percutaneous coronary intervention (PCI). New studies are needed to prove the safety and effectiveness of vagus nerve stimulation in patients with STEMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization of active stimulation vs. sham stimulation
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: TENSIt will be performed attached to the tragus of the left ear. |
| Sham TENS | Sham comparator | Device: TENSIt will be performed attached to the earlobe of the left ear. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with STEMI who have signed an informed voluntary consent to participate in the study;
- primary myocardial infarction;
- treatment in the first 12 hours from the onset of pain syndrome;
- primary PCI.
Key exclusion criteria (6 listed)
- acute heart failure III-IV;
- bradyarrhythmias;
- atrial fibrillation/flutter at the time of switching on;
- Thrombolytic therapy at the prehospital stage;
- a history of myocardial infarction;
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 |
|---|---|---|
| TENSTENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it. | Device | Active TENS, Sham TENS |
Primary outcome
Hospital mortality
Time frame: From date of randomization until the date of death from any cause, assessed up to 14 days.
The number of patients who died in the hospital.
30-day mortality
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 days.
The number of patients who died within 30 days from the development of myocardial infarction.
1 secondary outcome
Number of participants with non-lethal events.
Time frame: From the date of randomization to the date of any of the listed events, assessed up to 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publication: PubMed 40142674Kruchinova S, Gendugova M, Namitokov A, Sokolskaya M, Gilevich I, Tatarintseva Z, Karibova M, Danilov V, Simakin N, Shvartz E, Kosmacheva E, Shvartz V. Low-Frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve in Patients with ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. J Clin Med. 2025 Mar 10;14(6):1866. doi: 10.3390/jcm14061866.
- Low-Level Tragus Stimulation for the Treatment of Ischemia and Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction: A Proof-of-Concept StudyLink provided by the sponsor.
- Vagal Cardioprotection in Reperfused Acute Myocardial InfarctionLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Vladimir Shvartz, MD, DM principal investigator
Bakoulev Scientific Center for Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Vagus Nerve Stimulation and Acute Coronary Syndrome, run by Bakulev Scientific Center of Cardiovascular Surgery at 1 site in Russia.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: From date of randomization until the date of death from any cause, assessed up to 14 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992259, which also lists 1 linked publication.
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 20 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.