NCT03115242已完成不适用
Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke
Versailles Hospital2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Contrast enhancement of carotid plaque prevalence in ultrasound doppler
研究概览
简要总结
This is a biomedical, single-center, and prospective study of a consecutive patients cohort in acute ischemic stroke with carotid plaque.
详细描述
The main objective of this study is to evaluate the prevalence of the contrast taking carotid plaques in these acute ischemic strokes.
The secondary objectives are:
- to determine the clinical, sonographic, CT scanner and MRI characteristics of patients in constituted acute cerebral ischemia with carotid atherosclerotic plaque taking contrast to the doppler ultrasound.
- to explore of the plaque contrast enhancement at 6 months (new injection).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged at least 18 years hospitalized with ischemic stroke signs in the carotid territory, objectified on brain MRI with positive DWI.
- •Carotid plaque > 2.5 mm thickness in the ipsilateral carotid territory to the AIC, low echogenicity (Type 1, 2, 3, and 4a of the classification Geroulakos) measured by the assessment "GSM" (median gray level).
- •Free and informed consent patient or his representative for contrast injection microbubble.
- •Affiliated to health insurance.
排除标准
- •Severe cerebral infarction with NIHSS> 25
- •No-indications to the contrast medium injection
- •Recent myocardial infarction, unstable angina.
- •Heart failure stage III / IV New York Heart Association.
- •Cardiac shunt left-right, respiratory distress.
- •Allergy to albumin or contrast agents.
- •Carotid plaques and hyperechoic calcified (however these plaques will be counted to determine their prevalence in acute AIC).
- •Carotid dissection
研究组 & 干预措施
Acute ischemic carotid stroke
Experimental
Patients hospitalized in the neurovascular intensive care unit for an acute ischemic stroke with a carotid plaque responding to inclusion criteria.
These patients receive a contrast injection Sonovue® will be performed during the neck vessels doppler ultrasound.
干预措施: Contrast injection Sonovue® (Other)
结局指标
主要结局
Contrast enhancement of carotid plaque prevalence in ultrasound doppler
时间窗: Day 1
次要结局
- Patient's demographics data(Day 1)
- Patient's sonographic and MRI characteristics.(Day1)
- describe the aspect of the carotid plaque on CT angiography.(between 1 to 5 days)
- Cerebral infarction recurrence(Month 6)
- Persistence , decrease or loss of contrast enhancement in ultrasound doppler.(Month 6)
研究者
Dr Jean-Michel BAUD
Investigator coordinator
Versailles Hospital
研究点 (2)
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