跳至主要内容
临床试验/NCT05931003
NCT05931003进行中(未招募)不适用

Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees

Samara State Medical University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
2
主要终点
Change the degree of arterial hypertension

研究概览

简要总结

Carotid endarterectomy (CEA) is a well-established procedure for preventing ischemic brain damage. Stenosis of the precerebral vessels are often combined with arterial hypertension. In recent decades, many works have appeared that indicate that the course of arterial hypertension (AH) changes after CEA. However, it remains unknown how this is related to the choice of surgical tactics.

详细描述

Purpose of the study: to substantiate the choice of the method of surgical treatment in patients with a combination of hemodynamically significant stenosis of the carotid bifurcation and arterial hypertension of 2-3 degrees.

Tasks:

  1. To study the course of hypertension after carotid endarterectomy with removal of the carotid glomus.
  2. To study the course of hypertension in patients after stenting of the internal carotid artery.
  3. To substantiate the strategy for performing carotid endarterectomy in patients with bilateral significant lesions of the internal carotid artery.
  4. To substantiate the choice of a surgical treatment strategy in patients with significant stenosis of the carotid bifurcation and 2-3 degree of hypertension.

Methods for examining patients: collection of complaints and anamnesis, objective examination, questioning of patients, instrumental examination (ultrasound of BCS, daily monitoring of blood pressure, CT of the brain, cerebral angiography).

As a result of the study, the optimal tactics of surgical treatment in patients with carotid artery stenosis and the presence of hypertension will be determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Presence of symptomatic ICA stenosis 70-90%
  • Arterial hypertension of 2 or 3 degrees
  • CEA operation with carotid glomus removal or ICA stenting operation

排除标准

  • severe diabetes
  • traumatic brain injury in history
  • IHD, stable angina pectoris 3-4 FC.
  • presence of clinical signs of vertebrobasilar insufficiency
  • the presence of significant stenosis of the renal arteries
  • CKD stages 3b-5

研究组 & 干预措施

Carotid artery stenting

Experimental

Carotid artery stenting

干预措施: Carotid stenting (Procedure)

Carotid endarterectomy

Active Comparator

Carotid endarterectomy

干预措施: Carotid endarterectomy (Procedure)

结局指标

主要结局

Change the degree of arterial hypertension

时间窗: 2 years

Using ambulatory blood pressure monitoring (mmHg)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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