跳至主要内容
临床试验/NCT00222040
NCT00222040终止2 期

Microbubbles and Ultrasound in Stroke Trial: MUST Study

University Hospital, Toulouse5 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
20
试验地点
5
主要终点
Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.

研究概览

简要总结

To determine whether transcranial 2-MHz ultrasound combined with intravenous administration of microbubbles improves early recanalization in patients with acute ischemic stroke caused by middle cerebral artery (MCA) proximal occlusion treated with intravenous alteplase within 3 hours of symptom onset.

详细描述

Proximal MCA occlusion is recognized using MR or CT angiography performed before inclusion. All patients are treated with alteplase according to current guidelines. In addition, patients randomized in the active group are continuously exposed to transcranial 2-MHz ultrasound for 1 hour combined with intravenous administration of microbubbles. Controls are only treated with alteplase. The ultrasound beam is positioned at the thrombus/blood flow interface using color-coded sonography. Galactose-based microbubbles are administered via continuous intravenous infusion over 40 min.

Early recanalization is assessed using MR or CT angiography 4 to 8 hours after symptom onset. The evaluation of angiograms is performed by 2 neuroradiologists blinded to group of randomization and clinical details. The primary outcome measure is the rate of early recanalization. Recanalization is assessed using the TIMI classification. Secondary endpoints include the rate of symptomatic intracerebral hemorrhage, mortality, and functional outcome on the modified Rankin scale at 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute ischemic stroke
  • MCA proximal occlusion on CT or MR angiography
  • Thrombolysis with intravenous alteplase initiated within 3 hours of stroke onset

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

Levovist

干预措施: Ultrasound (Radiation)

1

Experimental

Levovist

干预措施: Levovist (Drug)

结局指标

主要结局

Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.

次要结局

  • Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale(3 months)

研究者

申办方类型
Other

研究点 (5)

Loading locations...

相似试验