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| ID | Type | Description | Link |
|---|---|---|---|
| P50NS044148-06 | U.S. NIH Grant/Contract | View source |
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Study terminated due to slow recruitment and funding ended.
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All stroke code patients | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound | Other | single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 24 hours after reference method |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Mattrey, MD | UCSD Stroke Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Hillcrest Medical Center | San Diego | California | 92101 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17416812 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | within 24 hours after reference method | number of vessel segments visualized | number of vessel segments visualized |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thilo Hoelscher, MD | University of California San Diego | 619-543-5251 | thoelscher@ucsd.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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|
| Sharp Memorial Hospital, 7901 Frost Street |
| San Diego |
| California |
| 92103-8756 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Stroke Code Patients - Transcranial Ultrasound | All acute stroke patients who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA) did receive a contrast-enhanced transcranial ultrasound study as well. |
|
|
| 0 |
| 61 |
| 0 |
| 61 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D055585 |
| Physical Phenomena |