Visualization of Cerebral Arteries Using Contrast-Enhanced Transcranial Ultrasound in Stroke Patients

NCT ID: NCT00282841

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2007-10-31

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All stroke code patients

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).

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: OTHER

single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound.

Interventions

ultrasound

single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound.

Intervention Type: OTHER

Other Intervention Names

Doppler

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Mattrey, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Stroke Center

Locations

University of California San Diego Hillcrest Medical Center

San Diego, California, United States

Sharp Memorial Hospital, 7901 Frost Street

San Diego, California, United States

Countries

United States

References

Holscher T, Sattin JA, Raman R, Wilkening W, Fanale CV, Olson SE, Mattrey RF, Lyden PD. Real-time cerebral angiography: sensitivity of a new contrast-specific ultrasound technique. AJNR Am J Neuroradiol. 2007 Apr;28(4):635-9.

Reference Type: BACKGROUND

PMID: 17416812 (View on PubMed)

Other Identifiers

P50NS044148-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50NS44148MATTREY

Identifier Type: -

Identifier Source: org_study_id