Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT05992259

Auricular Vagus Stimulation and STEMI

Led by Bakulev Scientific Center of Cardiovascular Surgery · Updated on 2025-06-18

300

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

B

Bakulev Scientific Center of Cardiovascular Surgery

Lead Sponsor

S

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Auricular Vagus Stimulation and STEMI

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with STEMI who have signed an informed voluntary consent to participate in the study
  • Primary myocardial infarction
  • Treatment within the first 12 hours from the onset of pain syndrome
  • Primary percutaneous coronary intervention (PCI)
Not Eligible

You will not qualify if you...

  • Acute heart failure III-IV
  • Bradyarrhythmias
  • Atrial fibrillation or flutter at the time of stimulation
  • Thrombolytic therapy before hospital admission
  • History of myocardial infarction
  • Previous PCI or coronary artery bypass grafting (CABG)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Scientific Research Institute Ochapovsky Regional Clinical Hospital

Krasnodar, Russia

Actively Recruiting

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Research Team

V

Vladimir Shvartz, MD, DM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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