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临床试验/NCT02397655
NCT02397655已完成不适用

Screening Carotid Artery and Intracranial Arteries by Ultrasound in Chinese Population With Transient Ischemic Attack and Ischemic Stroke: a Multi-center Registry Study

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 12,012 人开始时间: 2015年6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
12,012
试验地点
1
主要终点
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography

研究概览

简要总结

The purpose of this multicenter study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations with transient ischemic attack and ischemic stroke and analyze the influencing factors of atherosclerosis distribution pattern.

详细描述

In this multicenter study, carotid artery color doppler flow imaging and transcranial color code doppler or transcranial doppler will be used to screen the extra-/intra-cranial vessels in chinese populations with transient ischemic attack and ischemic stroke. The aim of this study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations and analyze the influencing factors of atherosclerosis distribution pattern.

  1. Ultrasound examinations procedures: According to the guidelines of vascular ultrasonography published by the Chinese Medical Doctor Association (CMDA) in 2009. The stenosis degrees of carotid artery, vertebral artery, subclavian artery as well as the middle cerebral artery are evaluated followed the criteria we published previously (references 1-4).

  2. Radiology examinations procedures: Enrolled patients receive CT or MRI examinations to determine the presence and the location of cerebral infarction. If necessary, patients receive CT angiography (CTA) or MRI angiography (MRA) examinations to confirm the degrees of vessel stenosis.

  3. The data collected in this study including:

  4. The general informations of enrolled subjects, which include name, gender, age, resident address, telephone number.Each subject is assigned an unique identification number.

  5. The history of stroke risk factors, which include 1) hypertension; 2) atrial fibrillation; 3) smoking; 4) dyslipidemia; 5) diabetes mellitus; 6) lack of physical activity (the standard of physical activity is ≥ 3 times per week and ≥30 min per time and the duration time ≥ 1 year);7) obvious overweight or obesity (BMI ≥ 26.0 Kg/m2);8) with family history of stroke.

  6. The medicines used within recent 2 weeks, the surgery name (such as stenting, carotid endarterectomy)if any.

  7. The results of vascular ultrasonography, ultrasonic cardiogram, radiology examinations, laboratory tests results (blood glucose, lipoproteins pattern, homocystein, C reactive protein, fibrinogen)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Hospitalized patients with age range ≥40 years and meet one of the following two criteria.
  • Patients with transient ischemic attack in recent 3 months.
  • Patients with ischemic stroke including acute and old cerebral infarction.

排除标准

  • cerebral hemorrhage;
  • vessel stenosis or occlusion caused by trauma,dissection or Takayasu's arteritis;
  • Stroke patients caused by patent foramen ovale.
  • Moyamoya disease;
  • Multiple sclerosis;
  • Mitochondrial myopathy.

结局指标

主要结局

Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography

时间窗: 30 days after subjects recruitment

By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, \<50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion. By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion. Patients with one of the above arteries having \>50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree.

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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