Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Scientific Research Institute Ochapovsky Regional Clinical Hospital
RECRUITING
Krasnodar
Contact Information
Primary
Vladimir Shvartz, MD, DM
vashvarts@bakulev.ru
+79032619292
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 300
Treatments
Active_comparator: Active TENS
It will be performed attached to the tragus of the left ear.
Sham_comparator: Sham TENS
It will be performed attached to the earlobe of the left ear.
Sponsors
Leads: Bakulev Scientific Center of Cardiovascular Surgery
Collaborators: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

This content was sourced from clinicaltrials.gov