Auricular Vagus Stimulation and STEMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-12-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Vagus Nerve Stimulation Acute Coronary Syndrome Ischemia Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization of active stimulation vs. sham stimulation

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active TENS

It will be performed attached to the tragus of the left ear.

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

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

Sham TENS

It will be performed attached to the earlobe of the left ear.

Group Type SHAM_COMPARATOR

TENS

Intervention Type DEVICE

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

Interventions

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TENS

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No