Study to investigate possible applications for MRI and ultrasound in the diagnosis of atherosclerosis of the carotid artery.|
|- candidate number||8234|
|- NTR Number||NTR2414|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2010|
|- Secondary IDs||09/182 METC AMC|
|- Public Title||Study to investigate possible applications for MRI and ultrasound in the diagnosis of atherosclerosis of the carotid artery.|
|- Scientific Title||Study to investigate the sensitivity and specificity of 3.0 Tesla MRI, MRS and ultrasound imaging for carotid artery plaque dimension and composition assessment.|
|- hypothesis||Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are non-invasive imaging modalities that can image plaque composition in-vivo in human carotid arteries with high sensitivity and specificity with regards to calcification, haemorrhage, fibrous cap and lipid rich necrotic cores.|
|- Healt Condition(s) or Problem(s) studied||Endarterectomy , Carotid artery stenosis|
|- Inclusion criteria||1. Patients are to meet the inclusion criteria of the Athero-Express study;|
2. These patients are eligible to undergo carotid endarterectomy in either the St. Antonius Hospital, Nieuwegein;
3. Willing and able to undergo non-invasive MRI, MRS and ultrasound examinations in the Academic Hospital Center, Amsterdam;
4. Signed informed consent.
|- Exclusion criteria||1. Patients not suitable for MRI (e.g. metal in the body, as a result of pacemaker or artificial cardiac valves);|
3. Surgery performed in the neck area of the carotid measurements.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jul-2010|
|- planned closingdate||1-jul-2012|
|- Target number of participants||50|
|- Primary outcome||To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for dimension and composition assessment of carotid artery plaques, in particularly those plaques with lipid rich necrotic cores.
1. Total plaque volume, plaque calcification volume, plaque haemorrhage volume, lipid rich necrotic core volume, fibrous cap thickness, as assessed by 3.0 Tesla MRI;
2. The ratio of the integrated lipid peak versus the unsuppressed water peak (expressed as a percentage), as assessed by MRS;
3. Carotid plaque presence and location, maximum plaque thickness and plaque composition, as assessed by B-mode ultrasound imaging;
4. Carotid intima-media thickness, arterial stiffness, blood flow velocity measured by B-mode ultrasound imaging.
5. Plaque size, morphology and phenotype (presence of collagen, smooth muscle cells, calcifications, macrophages, thrombus and fat), as assessed by histology analysis.
For the comparison of histology and MRI, MRS and ultrasound images the histological images are matched by observing the overall morphology such as lumen size and shape, wall size and shape, plaque configuration, as well as calcifications, landmarks of the plaque and the known distance of each slice from the common carotid bifurcation. Histology slices will be matched with MR images and ultrasound images based on anatomical landmarks.
|- Secondary outcome||To investigate sensitivity and specificity of carotid B-mode ultrasound imaging as a pre-screening assessment of carotid plaques for MRI and MRS studies.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Stroes|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Stroes|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Atherosclerosis is a protracted and in fact lifelong progressive disease. Over time, lipids accumulate in the artery wall forming fatty streaks, which eventually can develop into atherosclerotic plaques (1). The later stages of the process, from quiescent atherosclerotic plaque to an active plaque, have a high risk of triggering acute vascular events, such as myocardial infarction and stroke (1).
Much effort has been put in the development of novel drugs aimed to prevent cardiovascular disease. Low Density Lipoprotein cholesterol (LDL-C) lowering drugs, in particularly statins, play a pivotal role. The hypothesis that serum lipid lowering results in decrease of lipid accumulation in the arterial wall and thus atherogenesis, has formed the basis for successful drug developing strategies (1;2).|
To draw valid conclusions on determinants of disease and effectiveness of lipid modifying therapeutic intervention, imaging of atherosclerosis can be used as a validated tool to assess efficacy of novel compounds (3;4).
Although imaging arterial wall dimensions by B-mode ultrasound and intra-vascular ultrasound have proven their value, longitudinal data of the effects of cardiovascular drugs on arterial wall and plaque composition, in particular of vulnerable plaques with lipid rich necrotic cores (LRNC), are scarce.
Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are non-invasive imaging modalities that can potentially image plaque composition in-vivo in human carotid arteries. MRI image acquisition at various weightings enables visualisation of plaque composition. Calcification, haemorrhage, fibrous cap and lipid rich necrotic cores can readily be distinguished, providing information on plaque vulnerability. MRS gives a spectrum of resonances, affording detection of specific chemical components through their inherent frequency shift relative to water (5). In image guided MRS, an MR image can be utilized to image and localize a plaque. Proton spectra can then be collected from these plaques, such that the specific proton resonances of lipid components in a mobile state, including cholesterol ester (CE), can be identified (6).
|- Main changes (audit trail)|
|- RECORD||14-jul-2010 - 29-jul-2010|
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