Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2006-05-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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3-D ultrasound scanner
The availability of color flow Doppler combined with effective ultrasound contrast agents in transcranial sonography serves as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull.
Perflutren Protein-Type A Microspheres for injection
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Bolus: The recommended dose for activated DEFINITY® is 10 microliters (μL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (μL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* pregnant or nursing women
* history of neurological disease
* congenital heart defect
* severe liver dysfunction
* respiratory distress syndrome
* hypersensitivity or an allergic reaction to blood products.
18 Years
65 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Daniel T Laskowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Duke UMC
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Lindsey BD, Light ED, Nicoletto HA, Bennett ER, Laskowitz DT, Smith SW. The ultrasound brain helmet: new transducers and volume registration for in vivo simultaneous multi-transducer 3-D transcranial imaging. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Jun;58(6):1189-202. doi: 10.1109/TUFFC.2011.1929.
Ivancevich NM, Pinton GF, Nicoletto HA, Bennett E, Laskowitz DT, Smith SW. Real-time 3-D contrast-enhanced transcranial ultrasound and aberration correction. Ultrasound Med Biol. 2008 Sep;34(9):1387-95. doi: 10.1016/j.ultrasmedbio.2008.01.015. Epub 2008 Apr 18.
Smith SW, Ivancevich NM, Lindsey BD, Whitman J, Light E, Fronheiser M, Nicoletto HA, Laskowitz DT. The ultrasound brain helmet: feasibility study of multiple simultaneous 3D scans of cerebral vasculature. Ultrasound Med Biol. 2009 Feb;35(2):329-38. doi: 10.1016/j.ultrasmedbio.2008.08.016. Epub 2008 Oct 23.
Other Identifiers
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Pro00008393
Identifier Type: -
Identifier Source: org_study_id
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