What is this study trying to find out about ST-segment elevation myocardial infarction (STEMI)?

This study is evaluating whether noninvasive vagus nerve stimulation can improve outcomes for patients experiencing STEMI by reducing heart damage caused during treatment. Researchers aim to learn if this approach can decrease mortality and heart injury in patients undergoing primary PCI. The study is led by the Bakulev Scientific Center of Cardiovascular Surgery.

Who may be eligible for this ST-segment elevation myocardial infarction clinical trial?

Adults aged 40 to 75 years with a first-time STEMI who will receive primary PCI within 12 hours of symptom onset may be eligible. Both men and women can participate. People with severe heart failure, irregular heart rhythms, prior heart attacks, or previous heart surgeries are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this ST-segment elevation myocardial infarction clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly based on their individual circumstances.

Actively Recruiting

Phase Not Applicable

Age: 40Years - 75Years

All Genders

ID05992259

Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction

Led by Bakulev Scientific Center of Cardiovascular Surgery · Updated on 2025-06-18

300

Participants Needed

Research Sites

35 weeks

Total Duration

AI-Summary

What this Trial Is About

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

Brief Title

Auricular Vagus Stimulation and STEMI

Who Can Participate

Age: 40Years - 75Years

All Genders

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 PCI

You will not qualify if you...

Acute heart failure class III-IV
Bradyarrhythmias
Atrial fibrillation or flutter at the time of switching on
Thrombolytic therapy at the prehospital stage
History of myocardial infarction
Previous PCI or coronary artery bypass grafting (CABG)

Research Team

Vladimir Shvartz, MD, DM

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