PrimaryTo 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 (LRNC), with the aim to develop theseā¦
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Imaging
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 ultrasound imaging.
Histology
5. Plaque size, morphology and phenotype (presence of collagen, smooth muscle
cells, calcifications, macrophages, thrombus and fat), as assessed by histology
analysis.
Secondary outcome
no secundary study parameters
Background 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).
Study objective
Primary
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 (LRNC), with the aim to develop
these techniques to validated tools for clinical investigations and trials.
Secondary
To investigate sensitivity and specificity of carotid B-mode ultrasound imaging
as a pre-screening assessment of carotid plaques for MRI and MRS studies.
Study design
This is a non-invasive cross-sectional study, comparing carotid parameters of
in-vivo 3.0 Tesla MRI, MRS and B-mode ultrasound with histology specimens
collected at endarterectomy.
Study burden and risks
This study is conducted using non-invasive imaging technologies: MRI, MRS and
ultrasound imaging. There is no risk associated with participation.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
carotid artery stenosis, > 70 %, scheduled for carotid endarterectomy
Exclusion criteria
Not suitable for MRI (e.g. metal in the body, e.g. as a result of pacemaker or artificial cardiac valve implant), claustrophobia, former surgical procedures in the carotid area
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28938.018.09 |