Ignite Creation Date:
2024-05-05 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00677963
Status:
COMPLETED
Last Update Posted:
2011-04-20
First Post:
2008-05-08
Brief Title:
Contrast-enhanced Ultrasound CE-US and Magnetic Resonance Imaging MRI Evaluating Plaque Neovascularisation
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Contrast-enhanced Ultrasound and Magnetic Resonance Imaging for the Evaluation of Neovascularisation in Carotid Artery Plaques
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The first goal of this study is to investigate whether CE-US is able to accurately identify and quantify neovascularisation in carotid artery plaques Since this is one of the first studies systematically evaluating the ability of ultrasound in combination with air bubbles to evaluate neovascularisation in carotid artery plaques the examination will be performed twice with an interval of 12 hour on the day before surgery thus studying the reliability of the method
The second goal of this study is to investigate whether MRI at 30 T with a custom-designed 3T carotid coil using a recently developed pulse sequence is able to accurately identify and quantify neovascularisation And the third goal of this study is to make an intermodality comparison of CE-US and MRI regarding their ability to identify and quantify plaque neovascularisation
The second goal of this study is to investigate whether MRI at 30 T with a custom-designed 3T carotid coil using a recently developed pulse sequence is able to accurately identify and quantify neovascularisation And the third goal of this study is to make an intermodality comparison of CE-US and MRI regarding their ability to identify and quantify plaque neovascularisation
Detailed Description:
Atherosclerosis is a systemic disease of the large arteries and the leading cause of death in Western society The development of atherosclerosis involves the accumulation of lipids cells and extracellular matrix in the blood vessel wall It is a progressive disease characterized by the formation of a fibrous cap by smooth muscle cell proliferation and migration and the development of a necroticlipid core This core develops due to the accumulation of lipids and apoptosis of lipid-loaded macrophages In this process the intima the innermost layer of the blood vessel thickens This will lead to narrowing of the lumen and obstruction of blood flow The developed lesion of the vessel wall may become vulnerable to rupture of the fibrous cap Cap rupture exposes the necrotic core to the blood leading to the formation of a thrombus The thrombus may fully or partially obstruct the lumen and cause cardiovascular complications such as myocardial infarction or stroke Although atherosclerosis forms the origin of most cardiovascular diseases at present much remains unknown of the atherogenic process Therefore it is essential that research is done to discover novel mechanisms of atherosclerotic development Intimal neovascularisation has recently drawn much attention as a novel factor likely contributing to atherosclerotic plaque growth and rupture Neovascularisation occurs when the intima thickens and is associated with stenosis plaque inflammation and hemorrhage Because increased amount of neovascularisation may be associated with increased risk for stroke it would be highly desirable to identify plaque neovascularisation by noninvasive imaging At present imaging of neovascular development in atherosclerotic lesions with conventional ultrasound is not feasible since the vessel diameter is well below the resolution capacity of currently available ultrasound systems Since almost a decennium contrast-enhanced ultrasound CE-US with gaseous ultrasound contrast agents has been used for research purposes but is now also widely commercially available and registered for clinical use which can be done safely With the help of such a gaseous contrast medium containing air bubbles smaller than erythrocytes microbubbles it might be possible to depict neovascularisation in a carotid artery plaque due to the strong signal that will be evoked even by a small number of air bubbles as compared to the signal from the surrounding tissue So the intensity increase of the ultrasound signal from the carotid artery plaque after administration of microbubbles might reflect the amount of neovascularisation Until now only case reports concerning this technique have been published especially no comparison with histology has been performed So the first goal of this study is to investigate whether CE-US is able to accurately identify and quantify neovascularisation in carotid artery plaques Since this is one of the first studies systematically evaluating the ability of ultrasound in combination with air bubbles to evaluate neovascularisation in carotid artery plaques the examination will be performed twice with an interval of 12 hour on the day before surgery thus studying the reliability of the method Magnetic resonance imaging MRI is well suited for evaluating carotid plaques it is widely available provides excellent soft tissue contrast multiplanar imaging capability and is free of ionising radiation Multisequence MRI has shown to be able to detect different carotid plaque components in vivo However only very little experience exists in identifying neovascularisation by MRI Also newer MRI systems 15 T newer coil systems and better pulse sequences have recently become available Therefore the second goal of this study is to investigate whether MRI at 30 T with a custom-designed 3T carotid coil using a recently developed pulse sequence is able to accurately identify and quantify neovascularisation Finally the third goal of this study is to make an intermodality comparison of CE-US and MRI regarding their ability to identify and quantify plaque neovascularisation
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