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

Plain Language Summary

Simplified for easier understanding

This study is testing whether stimulating the vagus nerve through the ear (a non-invasive procedure using a small device placed on the outer ear) can reduce heart damage in people having a heart attack who are being treated with emergency artery-opening procedures. **You may be eligible if...** - You are having a heart attack (specifically an ST-elevation myocardial infarction, or STEMI) - It is your first heart attack - You are being treated within 12 hours of when your chest pain started - You are having an emergency procedure to open the blocked artery (primary PCI) **You may NOT be eligible if...** - You are in severe heart failure - You have a slow or irregular heart rhythm (bradyarrhythmia or atrial fibrillation) - You had clot-dissolving drugs before arriving at the hospital - You have had a previous heart attack or prior heart procedures (PCI or bypass surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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