Using auricular vagus stimulation to improve outcomes in heart attack patients
Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction
This study is testing if a non-invasive treatment that stimulates a nerve in the ear can help heart attack patients recover better and reduce damage to their hearts during emergency procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Bakulev Scientific Center of Cardiovascular Surgery Government |
| Locations | 1 site (Krasnodar) |
| Trial ID | NCT05992259 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous vagus nerve stimulation (TENS) on patients experiencing ST-segment elevation myocardial infarction (STEMI). It aims to reduce myocardial ischemia reperfusion injury (MIRI) during revascularization, which is a significant contributor to heart damage and poor outcomes. By stimulating the vagus nerve non-invasively, the study seeks to improve cardiac function, decrease inflammation, and enhance recovery in patients undergoing primary percutaneous coronary intervention (PCI). The trial will include patients treated within the first 12 hours of symptom onset to assess the immediate benefits of this intervention.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with STEMI who can consent and are treated within 12 hours of symptom onset.
Not a fit: Patients with severe acute heart failure, bradyarrhythmias, or a history of myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce heart damage and improve recovery outcomes for patients with STEMI.
How similar studies have performed: Previous small clinical trials have shown promising results for vagus nerve stimulation in reducing myocardial injury, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Krasnodar
- Scientific Research Institute Ochapovsky Regional Clinical Hospital — Krasnodar, Russia (Recruiting)
Study contacts
- Principal investigator: Vladimir Shvartz, MD, DM — Bakoulev Scientific Center for Cardiovascular Surgery
- Study coordinator: Vladimir Shvartz, MD, DM
- Email: vashvarts@bakulev.ru
- Phone: +79032619292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.