CompletedNot Applicable

A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention

China480 participantsStarted 2023-09-12

Plain-language summary

The goal of this clinical trial is to study the effect of transcutaneous auricular vagus nerve stimulation on perioperative blood pressure. The main question it aims to answer is: •Wether the transcutaneous auricular vagus nerve stimulation have advantages in perioperative blood pressure elevation. Participants will sign an informed consent form, collaborate with data collection, and are randomly divided into two groups(1:1) to accept the intervention measures from corresponding groups. Researchers will record the perioperative blood pressure and compare intervention group with sham group to see if there is any difference in perioperative blood pressure.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood pressure in the catheterization laboratory.

Timeframe: Before PCI in the catheterization laboratory

Trial details

NCT IDNCT06784583

SponsorGuozhe Sun

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-24

View on ClinicalTrials.gov More Coronary Artery Disease trials