The effect of carotid sinus neurectomy for carotid restenosis: a study protocol for a double-blinded and randomized controlled trial

作者全名："Zhang, Zhi; Ji, Xiang; Tao, Yihao; Huang, Ning; Wen, Rong; Tang, Jun; Cheng, Yuan; Xie, Zongyi; Liu, Guodong; Zhao, Guanjian"

作者地址："[Ji, Xiang; Tao, Yihao; Huang, Ning; Wen, Rong; Tang, Jun; Cheng, Yuan; Xie, Zongyi; Liu, Guodong; Zhao, Guanjian] Chongqing Med Univ, Affiliated Hosp 2, Dept Neurosurg, Chongqing 400010, Peoples R China; [Zhang, Zhi] Chongqing Med Univ, Affiliated Hospial 2, Dept Gynaecol & Obstet, Chongqing, Peoples R China"

通信作者："Liu, GD; Zhao, GJ (通讯作者)，Chongqing Med Univ, Affiliated Hosp 2, Dept Neurosurg, Chongqing 400010, Peoples R China."

来源：TRIALS

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001138961300002

JCR分区：Q3

影响因子：2.5

年份：2024

卷号：25

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Carotid endarterectomy; Carotid sinus nerve; Carotid artery restenosis; Inflammation; Randomized controlled trial

摘要："BackgroundPatients undergoing carotid endarterectomy (CEA) have a high restenosis rate, which increases the risk of stroke, and there is still a lack of effective treatment for restenosis. The cause of stenosis is related to local inflammatory reactions. Some basic studies have shown that the inflammatory response causing arterial stenosis is closely related to the nerve axons distributed in its outer membrane, and that removal of the nerve is effective in reducing the inflammatory response to prevent arterial stenosis. Therefore, we propose to design a randomized controlled trial to study whether disconnecting the carotid sinus nerve during a CEA operation can reduce carotid arterial restenosis.Method/designThis study is a randomized, double-blind, single-center study. We will recruit 276 patients, who will be randomly divided into the experimental group and the control group. Based on the standard CEA operation, the operator will search for the carotid sinus nerve on the surface of the internal carotid artery and will entirely transect it in the experimental group. Both groups will be guided with the same postoperative treatment and will be followed up every 3 months for 3 years after the operation. The main indices observed will be the carotid restenosis rate, incidence and nature of carotid plaque, and carotid blood flow velocity. Other indices will be arrhythmia, blood pressure variability, and biomarkers of atherosclerosis, such as blood lipids, hypersensitive C-reactive protein (hs-CRP), homocysteine, and total bilirubin.DiscussionIt is expected that carotid sinus nerve transection will significantly reduce the occurrence of restenosis after CEA, decrease the incidence of ischemic stroke, and realize the effective primary prevention of stroke.Trial registrationChiCTR2300073652. Registered on July 18, 2023."

基金机构：China postdoctoral science fund; [2022MD723750]

基金资助正文："This work was supported by the China Postdoctoral Science Fund (No. 2022MD723750) for collection, analysis, interpretation of data, and publication of the article. It was involved in supplementary material."