RecruitingNot ApplicableNCT05992259

Auricular Vagus Stimulation and STEMI

Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction


Sponsor

Bakulev Scientific Center of Cardiovascular Surgery

Enrollment

300 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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.

Interventions

DEVICETENS

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


Locations(1)

Scientific Research Institute Ochapovsky Regional Clinical Hospital

Krasnodar, Russia

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NCT05992259


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