The preventive and therapeutic effects of electroacupuncture on blood pressure and heart rate reduction in carotid artery stenting
| ISRCTN | ISRCTN31527328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31527328 |
- Submission date
- 24/02/2025
- Registration date
- 05/03/2025
- Last edited
- 03/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Carotid sinus reflex (CSR) is a common complication during and after carotid artery stenting (CAS), clinically manifested as bradycardia (slow heart rate) and hypotension (low blood pressure), which poses significant risks to patient safety. This study aims to investigate the effects of electroacupuncture on carotid sinus reaction occurring during and after carotid artery stenting.
Who can participate?
Patients aged 18-75 years diagnosed with carotid artery stenosis requiring carotid artery stenting
What does the study involve?
Participants will receive electroacupuncture treatment. The treatment is designed to stabilize hemodynamic changes (heart rate and blood pressure) during and after the carotid artery stenting procedure. The study will compare the outcomes of patients who receive electroacupuncture with those who do not, to evaluate its effectiveness in preventing or reducing carotid sinus reaction.
What are the possible benefits and risks of participating?
Possible benefits:
1. Participants may experience improved stabilization of heart rate and blood pressure during and after the procedure.
2. The study may contribute to a better understanding of how electroacupuncture can help manage carotid sinus reflex, potentially benefiting future patients with similar conditions.
Possible risks:
1. Normal reactions during acupuncture: You may experience sensations such as soreness, numbness, heaviness, or swelling, which are normal reactions to acupuncture. Additionally, dizziness may occur due to your physical condition or emotional tension, but it can be alleviated by stopping the acupuncture and resting appropriately.
2. Adverse reactions after acupuncture: Bleeding or hematoma may occur, but these can be resolved with local pressure. If an infection develops at the acupuncture site, your doctor will address it promptly.
Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine (China)
When is the study starting and how long is it expected to run for?
November 2024 to June 2026
Who is funding the study?
Beijing Hospital of Traditional Chinese Medicine (China)
Who is the main contact?
1. Dr Shaosong Wang, wangssmail@163.com
2. Dr Chuanjin Song, songcjmail@163.com
Contact information
Public, Scientific
Beijing Hospital of Traditional Chinese Medicine
Beijing
100010
China
 ORCID ID |
0009-0001-0976-7676 |
|---|---|
| Phone | +86 (0)17812003007 |
| songcjmail@163.com |
Principal Investigator
Beijing Hospital of Traditional Chinese Medicine
Beijing
100010
China
| Phone | +86 (0)13269211249 |
|---|---|
| wangssmail@163.com |
Study information
| Study design | Multicenter interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Vagal regulation-mediated effects of electroacupuncture on prevention and treatment of carotid sinus reflex in patients undergoing carotid artery stenting |
| Study objectives | Electroacupuncture can prevent and treat carotid sinus reflex induced by carotid artery stenting |
| Ethics approval(s) |
Approved 21/01/2025, Beijing Traditional Chinese Medical Hospital Ethics Committee (Beijing Hospital of Traditional Chinese Medicine, No. 23, Art Museum Back Street, Dongcheng District, Beijing, 100010, China; +86 (0)10 8790 6734; website@bjzhongyi.com), ref: 2024BL02-139-01 |
| Health condition(s) or problem(s) studied | Prevention and treatment of carotid sinus reflex in patients undergoing carotid artery stenting |
| Intervention | The randomization sequence will be generated by a statistician not involved in the trial using the random number table method. The allocation sequence will be concealed in sequentially numbered, sealed, opaque (non-recoverable) envelopes to ensure sequence confidentiality. Participants will be randomly allocated (1:1) to either the treatment group or control group. One group will receive a single continuous electroacupuncture treatment during the surgical procedure on the operation day. The other group will receive a single continuous non-acupoint shallow needling on the operation day. The treatment duration will span from the beginning to the end of the surgical procedure. Assessments will be conducted at baseline (pre-intervention), on the operation day, daily from surgery completion to discharge, and at 4 weeks post-discharge. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The incidence of carotid sinus reflex (CSR) incidence, calculated by comparing baseline blood pressure/heart rate with the lowest intraoperative and postoperative values recorded via continuous non-invasive monitoring and ECG during and after surgery |
| Secondary outcome measures | 1. Incidence of persistent carotid sinus reflex (CSR), measured using continuous hemodynamic monitoring data and anesthesia records intraoperatively and postoperatively until hospital discharge 2. Vasoactive drug utilization rate and postoperative pharmacological rescue rate: the percentage of patients requiring vasopressors/inotropes measured using anesthesia medication records and postoperative nursing charts during the procedure and postoperatively until discharge 3. Adverse event incidence rate: the frequency of complications (e.g., arrhythmias, stroke) measured using medical records and investigator-reported events from procedure initiation until hospital discharge 4. Neurological deficit measured using the NIH Stroke Scale (NIHSS) score at preoperative baseline (1 day before surgery), 1 hour postoperatively, 24 hours postoperatively, on the day of discharge, and 4 weeks post-discharge 5. Length of hospital stay: days from admission to discharge measured using hospital medical records at the time of discharge |
| Overall study start date | 01/11/2024 |
| Completion date | 01/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 128 |
| Key inclusion criteria | 1. European Society for Vascular Surgery (ESVS) 2023-defined carotid stenosis 2. CAS-indicated per Chinese Guidelines 2015 3. Willingness for endovascular intervention 4. Aged 18-75 years inclusive 5. Signed informed consent |
| Key exclusion criteria | 1. Presence of cardiac pacemaker 2. Documented severe dysfunction in any major organ system (cardiac, pulmonary, hepatic, or renal) 3. Identified coagulation disorders 4. Active skin infection at proposed acupuncture sites 5. Indication for emergency surgical intervention or additional neurointerventional procedures 6. Diagnosed psychiatric conditions or documented non-compliance that may compromise treatment protocol adherence 7. Documented intolerance to electroacupuncture therapy or history of severe adverse reactions 8. Anatomically unsuitable vascular access confirmed by imaging studies |
| Date of first enrolment | 22/01/2025 |
| Date of final enrolment | 01/05/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Department of Neurology
No. 23, Art Museum Back Street
Dongcheng District
Beijing
100010
China
Beijing
100034
China
Sponsor information
Hospital/treatment centre
No. 23, Art Museum Back Street, Dongcheng District
Beijing
100010
China
| Phone | +86 (0)10 52176677 |
|---|---|
| website@bjzhongyi.com | |
| Website | https://www.bjzhongyi.com/ |
"ROR" |
https://ror.org/057vq6e26 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 06/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Editorial Notes
24/02/2025: Study's existence confirmed by Beijing Traditional Chinese Medical Hospital Ethics Committee.
