Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of California, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00282841
First received: January 26, 2006
Last updated: September 10, 2009
Last verified: July 2008
  Purpose

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
Stroke
Procedure: ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: vessel recanalization during/post tPA administration [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]
  • sensitivity/specificity, positive/negative predictive value of contrast-enhanced ultrasound in comparison to CTA/MRA [ Time Frame: baseline, 30min, 3h, 24h, day30 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00282841

Locations
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
Investigators
Principal Investigator: Robert Mattrey, MD UCSD Stroke Center
  More Information

No publications provided

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

Keywords provided by University of California, San Diego:
stroke
ultrasound
occlusion
blockage
contrast solution

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014