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临床试验/NCT06058676
NCT06058676Enrolling By Invitation不适用

A Controlled Clinical Study of Prediction of Cerebral Hyperperfusion Syndrome After Carotid Artery Stenting by Using Multi-parameter Characteristics Based on Cerebral Autoregulation

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
1
主要终点
Cerebral hyperperfusion

研究概览

简要总结

Cerebral hyperperfusion syndrome (CHS) is one of the severe complication after carotid artery stenting with a high mortality rate. CHS was defined as cerebral hyperperfusion (CH) with clinical symptoms such as unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, aphasia, while CH could be a disastrous outcome causing complication after carotid revascularization if not managed properly and timely.

This is a single-center prospective cohort study to investigate the risks of CH after carotid artery stenting. All patients with severe carotid artery stenosis underwent carotid arterial ultrasonography and dynamic cerebral autoregulation (dCA) test by transcranial Doppler sonography (TCD) before operation. The postoperative carotid ultrasound and transcranial Doppler sonography (TCD) results are also needed. The investigators will collect this test data at 48h, 1 month and 3months after carotid artery stenting(CAS). According to the examination results, they were divided into two groups: CH group and non-CH group.

The investigators will collect data before CAS, on all participants' age, sex, heart rate, BP and end-tidal carbon dioxide (ET-CO2) and the following information from the patients : (i)demographic data, such as hypertension, coronary heart disease, diabetes, hyperlipidemia, smoking and body mass index; (ii) relevant clinical symptoms; (iii) preoperative colour Doppler ultrasonography(CDU)and transcranial Doppler sonography(TCD) results; (iv) The cerebral blood flow velocity (CBFV) of the middle cerebral artery(MCA) induced will be measured by non-invasively and continuously dCA test.

This study could be aimed to analyze the factors influencing cerebral hyperperfusion after CAS. The purpose of this study will be to perform more precise risk stratification for high-risk CH patients and improve the quality of life of them.

Statistical Analysis The Statistical Package for the Social Sciences(SPSS)software Version 26.0 (IBM, New York, USA) will be used for statistical analyses. The indicators with P < 0.2 in the univariate analysis will be entered into a logistic regression analysis to investigate the independent risk factors for CH after CAS. All tests will be performed two sided, and a P < 0.05 will be considered statistically significant.

详细描述

  1. To analysis the incidence of postoperative complications such as CH and CHS within 1 months and to find the risk factors of CH.

A. To enroll 400 cases of patients suffering from carotid artery stenosis. the investigators perform TCD on patients by Sonographer for identifying CH.

B. Postoperative CH will be defined in patients whose MCA mean velocity increased by more than 100% within 48 hour after carotid artery stent.

C. CH and CHS mostly occurs within one week after CAS. Although there are a few reports of CHS occurring from three weeks to four weeks after CAS.

D. All tests are non-invasive. 2. The diagnosis of CHS will be based on the following criteria:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 18 years and ≤
  • (2) Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography treatable with carotid artery stenting.
  • (3) Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone.

排除标准

  • (1) Patients with severe carotid artery stenosis caused by non-atherosclerosis diseases, such as dissection or arteritis.
  • (2) Inability to cooperate with all this examination.
  • (3) Patients without complete clinical or imaging information.
  • (4) Patients not evaluated by CDU before CAS or within 1 week after CAS.
  • (5) Lack of follow up with CDU after CAS.
  • (6) Patients with poor temporal sound window or closure of the temporal window.
  • (7) Hyperthyroidism, hemicrania, severe arrhythmia and other diseases affecting dCA.

结局指标

主要结局

Cerebral hyperperfusion

时间窗: within 7 days post-operation

Postoperative CH will be defined in patients whose MCA mean velocity increased by more than 100% after carotid artery stent.

次要结局

  • Cerebral hyperperfusion syndrome(with 1 month post-operation)
  • Major stroke(within 7 days post-operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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