Auricular Vagus Stimulation and STEMI

June 17, 2025 updated by: Vladimir A Shvartz, MD, Bakulev Scientific Center of Cardiovascular Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Krasnodar, Russian Federation
        • Recruiting
        • Scientific Research Institute Ochapovsky Regional Clinical Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active TENS
It will be performed attached to the tragus of the left ear.
Device: TENS
TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.
Sham Comparator: Sham TENS
It will be performed attached to the earlobe of the left ear.
Device: TENS
TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of randomization until the date of death from any cause, assessed up to 14 days.
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.
From date of randomization until the date of death from any cause, assessed up to 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The main hospital non-lethal events (Pulmonary edema, Cardiogenic shock, Cardiac arrhythmias: Atrial fibrillation, Ventricular tachycardia/fibrillation, Accelerated idioventricular rhythm/Atrioventricular block II, III).
From the date of randomization to the date of any of the listed events, assessed up to 14 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the level of myocardial damage.
Time Frame: Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.
Dynamics of Troponin I (hs-cTnI) in blood plasma.
Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.
Assessment of the level of inflammation.
Time Frame: Diagnosis will be carried out during hospitalization and after 24 hours.
Dynamics of high-sensitivity C-reactive protein (hs-CRP) in blood plasma. Dynamics of copeptin (CPP) in blood plasma.
Diagnosis will be carried out during hospitalization and after 24 hours.
Assessment of the level of heart failure
Time Frame: Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.
Dynamics of NT-proBNP in blood plasma.
Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakulev Scientific Center of Cardiovascular Surgery

Collaborators

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Investigators

  • Principal Investigator: Vladimir Shvartz, MD, DM, Bakoulev Scientific Center for Cardiovascular Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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