ParisK: Correlation of Imaging Techniques With Histology (ParisK)
|ClinicalTrials.gov Identifier: NCT01709045|
Recruitment Status : Unknown
Verified September 2013 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : October 17, 2012
Last Update Posted : September 13, 2013
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
|Condition or disease||Intervention/treatment|
|Stroke Plaque, Atherosclerotic||Other: Magnetic Resonance Imaging (MRI) Radiation: Dual-Energy Computed Tomography (DECT) Other: Ultrasound Other: Transcranial doppler|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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 Achieva
Radiation: Dual-Energy Computed Tomography (DECT)
Other Name: Siemens Flash
Other Name: Philips IU22
Other: Transcranial doppler
Other Name: Hemodynamics AG
- Ktrans on dynamic contrast-enhanced (DCE)-MRI [ Time Frame: 1 day ]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 ]The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.
- deformation pattern on ultrasound [ Time Frame: 1 day ]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 ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|