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临床试验/NCT04254432
NCT04254432Unknown1 期

Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-Stage Hypertension

Capital Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月30日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
20
试验地点
1
主要终点
tolerability and feasibility of remote ischemic conditioning on hypertension

研究概览

简要总结

Nowadays, the incidence of stroke in China has reached 1.6‰, and this disease has become a primary cause of death in China. One of its major risk factors is hypertension. As shown in the researches, the risk of stroke grows remarkably when the blood pressure increases and there exists a log-linear relationship between them. Systolic pressure and diastolic pressure relate to the risk of stroke independently. Systolic pressure decreasing 10mmHg will reduce the stroke risk by 31% and a decrease of 1~3mmHg will reduce the stroke risk by20~30%. As to diastolic pressure, a 5mmHg decrease will reduce the stroke risk by 34% and a 10mmHg decrease will reduce the stroke risk by 56%.In addition, patients with isolated systolic hypertension (SPB≥160mmHg, DPB≤90mmHg) or critical isolated systolic hypertension (SPB=140~159mmHg, DPB< 90mmHg) will suffer a higher risk of stroke than people with normal blood pressure. The ACC has already revised its Hypertension ManagementGuidelines of the standard of diagnosis for hypertension and the timing of starting medical treatment in hypertensive patients. Because more and more researches shown that people with blood pressure between 120-139/80-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than120/80mmHg; However, in China, the diagnostic criteria for hypertension has not been revised yet. Therefore, we still have a blind spot in treating such patients who suffer from borderline systolic hypertension at 130~140 mmHg of blood-pressure with or without ASCVD or those with the first stage hypertension but refusing to take anti-hypertension drugs. What is more, most of them are middle-aged adults, once they have a stroke, it would lead to terrible and costly consequences to both their family and society. Thus, it is necessary to explore new non-pharmacological methods to control blood pressure for reducing the risk of stroke

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • systolic blood pressure between 160 and 125 mmHg or diastolic blood pressure between 80 and 100 mmHg
  • essential hypertension
  • patient did not take anti-hypertensive medicine regularly

排除标准

  • patients with severe uncontrolled diabetes
  • contraindication for remote ischemic preconditioning
  • life expectancy less than 1 year
  • patients with atrial fibrillation or other kind of arrhythmia
  • unwilling to be followed up or poor compliance.

结局指标

主要结局

tolerability and feasibility of remote ischemic conditioning on hypertension

时间窗: 4 weeks

there are 56 treatments in totall during 4weeks, the percentage of the completement of each treatment would be used to mearure the tolerance.

次要结局

  • safety of remote ischemic conditioning on hypertension(4 weeks)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Xunming,MD,PhD

vice president

Xuanwu Hospital, Beijing

研究点 (1)

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