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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by University of California, San Diego.
Recruitment status was:  Active, not recruiting
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of California, San Diego Identifier:
First received: January 26, 2006
Last updated: September 10, 2009
Last verified: July 2008
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.

Condition Intervention
Procedure: ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Visualization of the Cerebral Arterial Circulation Using Contrast-Enhanced Transcranial Ultrasound in Code Stroke Patients

Resource links provided by NLM:

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • visualization of the intracranial arteries in comparison to reference method (MRA/CTA) [ Time Frame: within 24 hours ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 403
Study Start Date: May 2005
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
contrast-enhanced transcranial ultrasound to visualize the intracranial arteries
Procedure: ultrasound
single intravenous administration of max. 1.5ml ultrasound contrast agent (Definity), followed by max. 15min transcranial insonation using diagnostic ultrasound.

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 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00282841

United States, California
Sharp Memorial Hospital, 7901 Frost Street
San Diego, California, United States, 92103-8756
University of California San Diego Hillcrest Medical Center
San Diego, California, United States
Sponsors and Collaborators
University of California, San Diego
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Robert Mattrey, MD UCSD Stroke Center
  More Information

Responsible Party: Robert F. Mattrey, M.D., Director of Research, Department of Radiology, University of California, San Diego Identifier: NCT00282841     History of Changes
Other Study ID Numbers: P50NS44148MATTREY
Study First Received: January 26, 2006
Last Updated: September 10, 2009

Keywords provided by University of California, San Diego:
contrast solution

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 22, 2017