Overview

This trial is active, not recruiting.

Condition stroke
Treatment ultrasound
Sponsor University of California, San Diego
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date May 2005
End date May 2010
Trial size 403 participants
Trial identifier NCT00282841, P50NS44148MATTREY

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
contrast-enhanced transcranial ultrasound to visualize the intracranial arteries
ultrasound
single intravenous administration of max. 1.5ml ultrasound contrast agent (Definity), followed by max. 15min transcranial insonation using diagnostic ultrasound.

Primary Outcomes

Measure
visualization of the intracranial arteries in comparison to reference method (MRA/CTA)
time frame: within 24 hours

Secondary Outcomes

Measure
Measure: vessel recanalization during/post tPA administration
time frame: within 24 hours
sensitivity/specificity, positive/negative predictive value of contrast-enhanced ultrasound in comparison to CTA/MRA
time frame: baseline, 30min, 3h, 24h, day30

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Visualization of the Cerebral Arterial Circulation Using Contrast-Enhanced Transcranial Ultrasound in Code Stroke Patients
Principal investigator Robert Mattrey, MD
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 403 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by University of California, San Diego.