Using vagus nerve stimulation to manage blood pressure during heart procedures
A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention: a Randomized Clinical Trial
This study is testing whether a new method of stimulating the vagus nerve can help lower blood pressure spikes in people with high blood pressure during heart procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 494 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | China Medical University, China Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06784583 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of transcutaneous auricular vagus nerve stimulation on blood pressure during the perioperative period of percutaneous coronary interventions. Participants will be randomly assigned to either an intervention group receiving the stimulation or a sham group, with their perioperative blood pressure monitored and compared. The study aims to determine if this stimulation can mitigate blood pressure spikes, which are common in patients with hypertension undergoing such procedures. The research is grounded in the understanding that vagus nerve stimulation can influence autonomic balance and cardiovascular responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a history of hypertension who are scheduled for coronary artery stent implantation.
Not a fit: Patients with acute myocardial infarction, severe heart failure, or other significant cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of perioperative blood pressure, reducing complications for patients undergoing coronary interventions.
How similar studies have performed: Previous studies have shown promising results with vagus nerve stimulation in various contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages between 18 and 70 years old, regardless of gender * Patients with indications for coronary artery stent implantation * hypertension history * Voluntarily participate and sign an informed consent form Exclusion Criteria: * Patients with acute myocardial infarction * Patients with heart failure of NYHA class III - IV * Patients with atrial fibrillation (indicated by definite medical history or electrocardiogram on admission) * Patients with a medical history of hyperthyroidism * Patients with subclavian artery occlusion (indicated by definite medical history or a difference in systolic blood pressure of more than 20 mmHg between the two upper limbs) * With an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m² on admission * Patients with infections and fever * Patients who are unable to cooperate due to mental and psychological disorders (such as mania, depression) * Patients with tinnitus and vertigo * Pregnant women or patients who are attempting to get pregnant * Patients participating in clinical trials of other drugs or medical devices * Patients deemed unsuitable by the researchers to participate in this clinical trial
Where this trial is running
Shenyang, Liaoning
- First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Yingxian Sun — First Hospital of China Medical University
- Study coordinator: Guozhe Sun
- Email: gzhsun66@163.com
- Phone: 15040292137
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.