Actively Recruiting
Led by Bakulev Scientific Center of Cardiovascular Surgery · Updated on 2025-06-18
300
Participants Needed
1
Research Sites
35 weeks
Total Duration
B
Bakulev Scientific Center of Cardiovascular Surgery
Lead Sponsor
S
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Collaborating Sponsor
Researchers are exploring new treatments to improve outcomes for patients with ST-segment elevation myocardial infarction (STEMI), a serious type of heart attack. Despite effective invasive strategies like primary percutaneous coronary intervention (PCI), many patients still face high mortality and disability. This research focuses on studying transcutaneous vagus nerve stimulation (TENS) as a potential way to protect the heart, reduce injury caused by restoring blood flow, and improve heart function after a heart attack. The study compares two groups: one receiving active TENS applied to the tragus of the left ear, and the other receiving sham TENS applied to the earlobe. The stimulation starts upon admission to PCI, continues during the procedure, and lasts for 30 minutes afterward. This noninvasive device-based treatment aims to evaluate whether vagus nerve stimulation can reduce heart damage and improve clinical outcomes in patients undergoing primary PCI for STEMI. Participants will be monitored for safety and effectiveness through hospital and 30-day mortality rates, as well as non-lethal cardiac events up to 14 days after treatment. The study uses randomization and quadruple masking to ensure reliable results. Throughout the study, patients will receive assessments including clinical evaluations and follow-up to observe changes in heart function and overall health during and after the intervention. The total study period spans from admission through one month post-treatment.
CONDITIONS
Auricular Vagus Stimulation and STEMI
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several hours on the day of PCI
Participants receive noninvasive auricular vagus nerve stimulation starting from admission to the PCI, during the PCI, and for 30 minutes after the procedure.
1 treatment session on the day of PCI (in-person)
Duration - Up to 30 days
Participants are monitored for safety and outcomes including mortality and non-lethal events up to 30 days after treatment.
Approximately 2 follow-up visits within 30 days
Total: 1 location
1
Scientific Research Institute Ochapovsky Regional Clinical Hospital
Krasnodar, Russia
Actively Recruiting
V
Vladimir Shvartz, MD, DM
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Sofia Kruchinova, Milana Gendugova, Alim Namitokov...
https://pubmed.ncbi.nlm.nih.gov/40142674