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临床试验/NCT00282841
NCT00282841终止不适用

Visualization of the Cerebral Arterial Circulation Using Contrast-Enhanced Transcranial Ultrasound in Code Stroke Patients

University of California, San Diego4 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2005年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
61
试验地点
4
主要终点
Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)

研究概览

简要总结

The purpose of this study is to find out more about the usefulness of ultrasound in combination with a contrast solution to look for blood vessel blockage or occlusion in the brains of stroke patients.

详细描述

Ischemic stroke is a common, devastating and costly disease. A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain.

The purpose of this study is to visualize the blood vessels in the brain and to look for vessel occlusion (i.e., blockage) which may be the cause of stroke. Ultrasound contrast imaging may or may not improve the ability to diagnose vessel occlusion in the brain quickly and precisely, thereby expediting the therapy currently in place for acute stroke.

The contrast solutions used in this study have been approved by the Food and Drug Administration because they improve ultrasound pictures taken in the heart. While the solutions are approved for use with ultrasound in viewing the heart, the usefulness in viewing brain vessels has not been approved and is experimental.

The study will enroll 400 participants with possible diagnosis of acute stroke. Individuals participating in the study will be injected with a contrast solution via an intravenous line. A small probe will be used to obtain images of blood vessels in the head. The study researchers will measure vital signs prior to injection of the contrast solution, 5 minutes after the injection, and at the end of the ultrasound. Each participant will have a 5-minute mental function assessment and a brief neurological exam. Participants will undergo at least 3 ultrasounds. The total time of each ultrasound is less than 30 minutes.

This study is part of the Specialized Program of Translational Research in Acute Stroke to enhance and initiate translational research that ultimately will benefit stroke patients. Results from this study may help investigators learn about the future development of new diagnostic tests for stroke.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • patient 18 years of age or older
  • code stroke patient

排除标准

  • women with positive pregnancy test
  • women who are breast feeding
  • severe emphysema
  • pulmonary vasculitis
  • history of pulmonary emboli
  • chronic renal failure

研究组 & 干预措施

All stroke code patients

Experimental

After written informed consent Code Stroke patients will undergo a contrast-enhanced transcranial ultrasound study to visualize the intracranial arteries. To do so, an ultrasound contrast agent (Definity) will be administered intravenously and transcranial ultrasound will be applied via the temporal bone window on both sides. Goal is to visualize and assess the intracranial arteries bilaterally. This includes the following vessel segments on both sides: middle cerebral artery (M1,M2,M3 segments), anterior cerebral artery (A1,A2 segments), posterior cerebral artery (P1,P2 segments), internal carotid artery (C1/2,C3/4 segments).

干预措施: ultrasound (Other)

结局指标

主要结局

Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)

时间窗: within 24 hours after reference method

The number of participants with successful visualization (yes/no) of the cerebral artery segments was assessed by an experienced sonographer who was blinded to the cerebral MRA/CTA.

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 (4)

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