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临床试验/NCT03821571
NCT03821571Unknown1 期

Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月25日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
60
试验地点
2
主要终点
Cerebrovascular reactivity

研究概览

简要总结

Hypertension is known to be the major risk factor for stroke. The most common cause of secondary hypertension, primary aldosteronism (PA), is characterized by the excessive secretion of aldosterone and is related to hypertension and hypokalemia. PA accounts for 3-10 % of hypertensive patients, and a higher incidence of vascular complications compared to patients with essential hypertension was observed in several studies. The vascular injury from excessive aldosterone can occur via oxidative stress and collagen remodeling, causing endothelial dysfunction and fibrosis in the vasculature.

The association between cerebral small vessel disease (cSVD) and hypertension has been well studies in the past decades. However, not much study has focused on the cSVD burden in patient with PA. The goal of this study is to understand the features of cSVD in patients with PA and for the purpose of understanding the underlying pathophysiology of cerebrovascular injury in this particular patient group.

研究设计

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

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 20-90 years-old
  • patient with primary aldosteronism or healthy control
  • consciousness clear
  • willing to receive brain MRI

排除标准

  • renal failure or Creatinine > 2mg/dl
  • coagulopathy or hepatic insufficiency
  • unstable vital sign under inotropic agents
  • pregnancy
  • metal implant or cardiac pacemaker
  • major brain surgery

研究组 & 干预措施

Patient with primary aldosteronism

Experimental

Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.

干预措施: Brain MRI (Diagnostic Test)

Patient with essential hypertension

Active Comparator

Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.

干预措施: Brain MRI (Diagnostic Test)

结局指标

主要结局

Cerebrovascular reactivity

时间窗: During the brain MRI

Cerebrovascular reactivity measured by MRI under primary aldosteronism

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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