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Auricular Vagus Stimulation and STEMI

NCT05992259 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-06-18

No results posted yet for this study

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. 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

  • Vagus Nerve Stimulation
  • Acute Coronary Syndrome
  • Ischemia Reperfusion Injury

Interventions

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.

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • Bakulev Scientific Center of Cardiovascular Surgery

    lead OTHER_GOV

Principal Investigators

  • Vladimir Shvartz, MD, DM · Bakoulev Scientific Center for Cardiovascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-03-30
Completion
2026-12-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05992259 on ClinicalTrials.gov