Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282841
Status:
TERMINATED
Last Update Posted:
2019-08-07
First Post:
2006-01-26
Brief Title:
Visualization of Cerebral Arteries Using Contrast-Enhanced Transcranial Ultrasound in Stroke Patients
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Visualization of the Cerebral Arterial Circulation Using Contrast-Enhanced Transcranial Ultrasound in Code Stroke Patients
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to slow recruitment and funding ended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
The purpose of this study is to visualize the blood vessels in the brain and to look for vessel occlusion ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50NS044148-06 | NIH | None | httpsreporternihgovquickSearchP50NS044148-06 |