ParisK: Correlation of Imaging Techniques With Histology (ParisK)
Recruitment status was Recruiting
The possibility to identify the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. A vulnerable plaque is considered to have a large lipid rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells, intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to validate imaging of plaque vulnerability with histology. Previous studies have evaluated the use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation between imaging and histology and/or clinical characteristics. However, they have focused on single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small cohorts
The primary goal of this study is to investigate whether there is a correlation between neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the correlation between the volume of the LRNC as determined by dual-energy CT and histology.
Secondly, the investigators will investigate the correlation between the volume of the LRNC, the fibrous cap status and the volume of the calcifications determined by MRI versus histology, the correlation between number of microembolisms and fibrous cap status and the correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.
The imaging parameters showing good correlation with plaque vulnerability characteristics can be used for further analysis in assessing the vulnerable plaque
Other: Magnetic Resonance Imaging (MRI)
Radiation: Dual-Energy Computed Tomography (DECT)
Other: Transcranial doppler
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology|
- Ktrans on dynamic contrast-enhanced (DCE)-MRI [ Time Frame: 1 day ] [ Designated as safety issue: No ]The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.
- Lipid-rich necrotic core on dual-energy CT [ Time Frame: 1 day ] [ Designated as safety issue: No ]The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.
- deformation pattern on ultrasound [ Time Frame: 1 day ] [ Designated as safety issue: No ]The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.
- number of recorded micro embolic signals (MES) [ Time Frame: 1 day ] [ Designated as safety issue: No ]The relation between number of recorded MES and fibrous cap status at histology.
- Volume of LRNC and calcifications and fibrous cap status on MRI [ Time Frame: 1 day ] [ Designated as safety issue: No ]The correlation between volume of LRNC, fibrous cap status and volume of calcifications in carotid atherosclerotic plaques visualised by MRI and the same features as determined at histology.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients scheduled for CEA
All patients who are scheduled for carotid endarterectomy (CEA)
Other: Magnetic Resonance Imaging (MRI)
Multi-sequence MR protocol
Other Name: 3.0 T Philips AchievaRadiation: Dual-Energy Computed Tomography (DECT)
Other Name: Siemens FlashOther: Ultrasound
Other Name: Philips IU22Other: Transcranial doppler
Other Name: Hemodynamics AG
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709045
|Maastricht University Medical Center||Recruiting|
|Maastricht, Limburg, Netherlands|
|Contact: Eline Kooi, PhD firstname.lastname@example.org|
|Study Chair:||Eline Kooi, PhD||Maastricht University Medical Center|