Auricular Vagus Stimulation and STEMI
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJune 18, 2025
June 1, 2025
3.6 years
June 27, 2023
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospital mortality
The number of patients who died in the hospital.
From date of randomization until the date of death from any cause, assessed up to 14 days.
30-day mortality
The number of patients who died within 30 days from the development of myocardial infarction.
From date of randomization until the date of death from any cause, assessed up to 30 days.
Secondary Outcomes (1)
Number of participants with non-lethal events.
From the date of randomization to the date of any of the listed events, assessed up to 14 days.
Other Outcomes (3)
Assessment of the level of myocardial damage.
Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.
Assessment of the level of inflammation.
Diagnosis will be carried out during hospitalization and after 24 hours.
Assessment of the level of heart failure
Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.
Study Arms (2)
Active TENS
ACTIVE COMPARATORIt will be performed attached to the tragus of the left ear.
Sham TENS
SHAM COMPARATORIt will be performed attached to the earlobe of the left ear.
Interventions
TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scientific Research Institute Ochapovsky Regional Clinical Hospital
Krasnodar, Russia
Related Publications (1)
Kruchinova S, Gendugova M, Namitokov A, Sokolskaya M, Gilevich I, Tatarintseva Z, Karibova M, Danilov V, Simakin N, Shvartz E, Kosmacheva E, Shvartz V. Low-Frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve in Patients with ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. J Clin Med. 2025 Mar 10;14(6):1866. doi: 10.3390/jcm14061866.
PMID: 40142674DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir Shvartz, MD, DM
Bakoulev Scientific Center for Cardiovascular Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, DM, Professor
Study Record Dates
First Submitted
June 27, 2023
First Posted
August 15, 2023
Study Start
September 1, 2022
Primary Completion
March 30, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share