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Clinical Trials/NCT00282841
NCT00282841
Terminated
N/A

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

University of California, San Diego2 sites in 1 country61 target enrollmentMarch 2005
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of California, San Diego
Enrollment
61
Locations
2
Primary Endpoint
Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
October 2007
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (2)

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