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临床试验/NCT01126775
NCT01126775Unknown不适用

Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 Systematische Prävention Bei Hochrisikopatienten für Schlaganfall Und vaskulär (Mit)Bedingte Demenz: Identifizierung Und Behandlung Von Stummen Hirninfarkten.

INVADE gGmbH2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
INVADE gGmbH
入组人数
1,000
试验地点
2
主要终点
In the group of high-risk persons the percentage of silent strokes detected by MRI of the brain is significantly higher than in the group of non-high-risk persons.

研究概览

简要总结

"Silent" strokes are more frequent than clinical apparent strokes and can be detected noninvasively by MRI-investigations of the brain. Persons with silent strokes have a considerably increased risk for clinical apparent strokes as well as for the development of dementia. Intention of the study is the detection of silent strokes and microbleedings by standardized cranial MRI in 1000 participants (500 high-risk and 500 low-risk persons for cerebrovascular accidents) after a standardized neurological and neuropsychological examination. Results will be the base of early detection and early preventive strategies of cerebrovascular accidents in high-risk persons.

In the course of a systematic follow-up examination without MRI the same 1000 patients (500 high-risk and 500 low-risk persons for cerebrovascular accidents) will be reinvited to the sites. In addition to the standardized neurological and neuropsychological examinations a surrogate parameter of nephropathy, microalbumin, will be examined as this parameter could be helpful in forecasting cerebral microangiopathy. The clinical investigation will be expanded by several tests in order to assess symptoms of cerebral microangiopathy.

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
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • signed informed consent for NPV-2
  • ongoing participation in INVADE-2
  • completed participation in Neuroprävention study (NPV-1)

排除标准

  • not completed Neuroprävention study (Drop-out)
  • disagreement of notification of incidental findings
  • lack of capacity to consent of study participant
  • lack of willingness to cooperate of study participant

结局指标

主要结局

In the group of high-risk persons the percentage of silent strokes detected by MRI of the brain is significantly higher than in the group of non-high-risk persons.

时间窗: 4/2012 until 11/2013

次要结局

  • Detection of silent strokes by MRI in more than 10% of all subjects and diagnostic and therapeutic procedures refinancable near-term and in relation to long-term-consequences(4/2012 until 11/2013)
  • Detection of microbleedings by MRI in more than 10% of all subjects(4/2010 until 11/2011)

研究者

发起方
INVADE gGmbH
申办方类型
Other
责任方
Sponsor

研究点 (2)

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