Actively Recruiting
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
Eligibility Criteria
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)
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
Trial Site Locations
Total: 1 location
1
Scientific Research Institute Ochapovsky Regional Clinical Hospital
Krasnodar, Russia
Actively Recruiting
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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