Stroke
Conditions
Keywords
stroke, ultrasound, occlusion, blockage, contrast solution
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.
Interventions
OTHERultrasound
single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA) | within 24 hours after reference method | The number of participants with successful visualization (yes/no) of the cerebral artery segments was assessed by an experienced sonographer who was blinded to the cerebral MRA/CTA. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Stroke Code Patients Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA). | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | All Stroke Code Patients |
|---|---|
| Age, Continuous | 64.82 years |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)
The number of participants with successful visualization (yes/no) of the cerebral artery segments was assessed by an experienced sonographer who was blinded to the cerebral MRA/CTA.
Time frame: within 24 hours after reference method
Population: Based on the assumption that all target intracranial vessel segments could be visualized with either one of the reference methods, CTA or MRA, in all patients enrolled, the transcranial ultrasound data was analyzed to assess how many of the target vessel segments could be visualized in comparison to the reference method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stroke Code Patients - Reference Method | Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA) | 8 participants |
| Stroke Code Patients - Transcranial Ultrasound | Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA) | 8 participants |