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临床试验/NCT02016768
NCT02016768已完成不适用

Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Change from baseline in the systolic blood pressure(SBP) measured by 24-hour Ambulatory Blood Pressure Monitoring(ABPM) on 1st month and 3th month post-operation.

研究概览

简要总结

There is a relationship between CSM and hypertension, probably a cause/effect relationship, and investigators term this type of hypertension "cervicogenic hypertension". Abnormally functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate and inhibit parts of the central and autonomic nervous systems as part of a chronic stress response, which causes hypertension and migraine. This theory is now being expanded to encompass both CSM and essential hypertension, the idea being that these two conditions are intimately related.

详细描述

Cervical spondylotic myelopathy (CSM) and hypertension are both very common diseases in the general population.Investigators have also observed previously hypertensive patients with CSM become normotensive following decompressive cervical surgery and no longer need antihypertensive medications. Both observations are difficult to explain according to current theories of the two diseases.

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 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Established diagnosis of cervical spondylosis myelopathy
  • Be at least 18 years of age
  • Office-measured systolic BP≧140mmHg
  • Ability to adhere to study protocol
  • Have signed an approved informed consent form for participation in this study

排除标准

  • Have hypertension secondary to a treatable cause
  • Have prior cervical spine surgery
  • Are pregnant or contemplating pregnancy during the 3-month follow-up period
  • People deny to join the study
  • Are unable to comply with protocol requirements
  • Are unlikely to survive the protocol follow-up period
  • Are enrolled in another concurrent clinical trial
  • Visual Analogue Scale≥4

结局指标

主要结局

Change from baseline in the systolic blood pressure(SBP) measured by 24-hour Ambulatory Blood Pressure Monitoring(ABPM) on 1st month and 3th month post-operation.

时间窗: twice ABPM prior to operation and 1st month, 3th month post-operation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Liu

Dr.

Peking University First Hospital

研究点 (1)

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