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临床试验/NCT01429948
NCT01429948已完成不适用

Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 581 人开始时间: 2008年4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
581
试验地点
1
主要终点
Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring

研究概览

简要总结

We hypothesized that paradoxical embolism may be one of the main mechanisms of silent cerebral infarction (SCI) located outside the perforating artery territory. In the present study, we evaluated the association between SCI and paradoxical embolism detected by agitated saline transcranial Doppler (TCD) monitoring in healthy subjects without history of stroke or transient ischemic attack (TIA). We also compared the frequency and amount of paradoxical embolism between healthy subjects with SCI and acute stroke patients with presumed cryptogenic embolism or conventional stroke mechanisms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Healthy subjects
  • Subjects with age over 20 years
  • Subjects who consecutively visited a health promotion center for a health screening examination that included routine laboratory test, cardiac work-ups (12-lead electrocardiography and/or echocardiography), and brain magnetic resonance image (MRI) and MR angiography (MRA)
  • Subjects who showed silent brain infarction (SCI) which was defined as a focal hyperintensity lesion 3 mm or large in diameter in the fluid-attenuation inversion recovery (FLAIR) images without a history of a corresponding stroke or transient ischemic attack (TIA)
  • Subjects who performed agitated saline transcranial Doppler (TCD) monitoring
  • Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)
  • Patients with age over 20 year
  • Patients with focal neurologic deficits presented within 7 days of symptom onset
  • Patients with acute ischemic lesions on diffusion-weighted image (DWI)
  • Patients who performed agitated saline TCD monitoring

排除标准

  • Healthy subjects
  • Subjects with the presence of previous history of stroke or TIA
  • Subjects with the presence of dementia on history taking or mini-mental status examination
  • Subjects with the presence of proximal source of embolism, including atrial fibrillation or significant (≥50%) stenosis on cervicocerebral artery on MRA or carotid Duplex
  • Subjects who had SCI restricted within perforator territory (basal ganglia or pons) suggesting that microangiopathy rather than embolism could be the main mechanism of SCI
  • Subjects in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows
  • Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)
  • Patients in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows

结局指标

主要结局

Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring

时间窗: Within a month after MRI scanning

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 (1)

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