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临床试验/NCT03815513
NCT03815513Unknown1 期

Non-invasive Evaluation of Cerebrovascular Reactivity in Spontaneous Intracerebral Hemorrhage

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21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
Ischemic stroke recurrence

研究概览

简要总结

Spontaneous intracerebral hemorrhage (ICH) remains a significant cause of morbidity and mortality around the globe. The most common etiology of nontraumatic spontaneous ICH is hypertensive arteriopathy (HA), while cerebral amyloid angiopathy (CAA) is the most prevalent cause of spontaneous lobar ICH in the elderly. Both HA and CAA belong to the family of cerebral small vessel disease (cSVD). cSVD involves pathological processes that affect the arteries, arterioles, capillaries, and veins on the surface and beneath the brain. The resultant changes of cSVD in the brain vasculatures can be detected with neuroimaging, includes cerebral microbleeds, white matter hyperintensities, lacunes, dilated perivascular spaces, and brain atrophy.

Investigators of this study have probe into various imaging markers in patients with cSVD. Investigators found that the lacune and cerebral microbleeds location was related to distinct underlying etiology of cSVD. Further, investigators utilized amyloid PET study to directly quantified the cerebral amyloid burden, and demonstrated the correlation between amyloid deposition and deep/superficial microbleeds ratio. The association between cerebellum microbleeds, which is a novel marker for cSVD, and the underlying pathology in patient with spontaneous ICH has been investigated. Investigators also summarized and published the current research of different cSVD imaging markers and its implication on patient care.

Cerebrovascular reactivity (CVR) represents the phenomenon that cerebral vessels dilate or constrict in response to stimuli, which provides insights into the vascular reserve information. The vascular reserve parameter is complementary to steady-state vascular index, such as cerebral perfusion or other neuroimaging markers. Measurement of CVR using advanced MR techniques is an emerging technique with multiple potential clinical utilities, and impaired autoregulation may contribute to the pathogenesis of cSVD. Recently, diminished CVR under visual stimuli has been linked to vascular amyloid deposits and related vascular dysfunction. Clarifying the mechanism of cSVD-related brain injury would be an important step towards identifying candidate treatment approaches.

The goal of this study is to understand the features of CVR in patients with cSVD-related spontaneous ICH, for the purpose of establishing new biomarkers in cSVD diagnosis and understanding the underlying pathophysiology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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 spontaneous intracerebral hemorrhage 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
  • allergy to Dipyridamole
  • pregnancy
  • asthma history
  • metal implant or cardiac pacemaker

研究组 & 干预措施

cases

Experimental

Patient with spontaneous intracerebral hemorrhage

干预措施: brain MRI (Other)

controls

Experimental

Healthy control without history of symptomatic cerebrovascular diseases

干预措施: brain MRI (Other)

结局指标

主要结局

Ischemic stroke recurrence

时间窗: The patients will be follow up in the outpatient clinic for 2 years.

Symptomatic ischemic stroke recurrence during follow-up

Intracerebral hemorrhage recurrence

时间窗: The patients will be follow up in the outpatient clinic for 2 years.

Symptomatic intracerebral hemorrhage recurrence during follow-up

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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