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临床试验/NCT01233986
NCT01233986Unknown不适用

Prospective, Matched Case Control, Multicenter, Observational Study for the Association of Serum Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS)

Hallym University Medical Center1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
112
试验地点
1
主要终点
The serum level of fasting apolipoprotein B-48

研究概览

简要总结

The purpose of this study is to evaluate whether the serum apoB48 level is associated with atherosclerotic ischemic stroke.

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

  • Large artery atherosclerotic ischemic stroke group(LAA group)
  • Age over 20 years
  • Patients with symptomatic stenosis in the eligible vessels(the middle cerebral artery, anterior cerebral artery, or internal carotid artery) as assessed by MRA or CTA corresponding to the acute ischemic stroke
  • Patients without the occlusion of corresponding artery by MRA or CTA
  • The fasting and postprandial serum Apo B-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke
  • Small vessel occlusive ischemic stroke group (SVO group)
  • Age over 20 years
  • Patients with acute ischemic stroke of basal ganglia, internal capsule, or corona radiata
  • Patients without both symptomatic and asymptomatic arterial occlusion or stenosis by MRA or CTA
  • Patients without a history of systemic atherosclerosis(for example, acute myocardial infarction, angina, peripheral arterial disease, aortic aneurysm)
  • The fasting and postprandial serum Apo B-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke

排除标准

  • both LAA group and SVO group
  • Patients with cardioembolic ischemic stroke
  • Patients treated with lipid lowering agents or steroid within the previous 30 dsys
  • Patients with severe liver disease (AST >100 or ALT >100) at the time of randomization
  • Patients with endocrine disease except diabetes mellitus at the time of randomization (for example, thyroid disease, adrenal disease)
  • Patients with severe renal disease (serum creatinine >2.0mg/dl)at the time of randomization
  • chronic alcoholics or drug user
  • Patients with infection at the time of randomization
  • Patients, in the opinion of the investigator, unlikely to comply with the clinical study or unsuitable for the any other disease or reason
  • Informed consent has not been obtained

结局指标

主要结局

The serum level of fasting apolipoprotein B-48

时间窗: 72 hours within stroke onset

The serum level of postprandial apolipoprotein B-48

时间窗: within 72 hours after stroke onset

次要结局

  • The serum level of fasting total cholesterol(within 72 hours after stroke onset)
  • The serum level of the postprandial triglyceride(72 hours within stroke onset)
  • The serum level of fasting LDL cholesterol(within 72 hours after stroke onset)
  • the level of fasting HDL cholesterol(within 72 hours after stroke onset)
  • the level of fasting triglyceride(within 72 hours after stroke onset)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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