ParisK: Correlation of Imaging Techniques With Histology "ParisK"

Recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • Ultrasound Device
    ARM 1: Kind: Experimental
    Label: Patients scheduled for CEA
    Description: All patients who are scheduled for carotid endarterectomy (CEA)
  • Magnetic Resonance Imaging (MRI) Device
    Intervention Desc: Multi-sequence MR protocol
    ARM 1: Kind: Experimental
    Label: Patients scheduled for CEA
    Description: All patients who are scheduled for carotid endarterectomy (CEA)
  • Dual-Energy Computed Tomography (DECT) Radiation
    Other Names: Siemens Flash
    ARM 1: Kind: Experimental
    Label: Patients scheduled for CEA
    Description: All patients who are scheduled for carotid endarterectomy (CEA)
  • Transcranial doppler Diagnostic Test
    ARM 1: Kind: Experimental
    Label: Patients scheduled for CEA
    Description: All patients who are scheduled for carotid endarterectomy (CEA)

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy, will be included.

Outcomes

Type Measure Time Frame Safety Issue
Primary Ktrans on DCE-MRI 1 day No
Primary Lipid-rich necrotic core on dual-energy CT 1 day No
Secondary deformation pattern on ultrasound 1 day No
Secondary number of recorded micro embolic signals 1 day No
Secondary Volume of LRNC and calcifications and fibrous cap status on MRI 1 day No
Primary Ktrans on dynamic contrast-enhanced (DCE)-MRI 1 day No
Secondary number of recorded micro embolic signals (MES) 1 day No

Biospecimen Retention:Samples Without DNA - Carotid plaque removed during carotid endarterectomy

Sponsors