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Completed

NCT Number: NCT05992259

Auricular Vagus Stimulation and STEMI

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.

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Key information

Conditions

Vagus Nerve Stimulation Acute Coronary Syndrome Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Ischemia Reperfusion Injury Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury ST Elevation Myocardial Infarction Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scientific Research Institute Ochapovsky Regional Clinical Hospital

Krasnodar, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

TENS

Device

TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Bakulev Scientific Center of Cardiovascular Surgery

Other Gov

Collaborators

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

Registry information

Official study title

Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2023
Registry last updated
Jul 20, 2026

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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