ParisK: Correlation of Imaging Techniques With Histology
Study Details
Study Description
Brief Summary
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 | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients scheduled for CEA All patients who are scheduled for carotid endarterectomy (CEA) |
Other: Magnetic Resonance Imaging (MRI)
Multi-sequence MR protocol
Other Names:
Radiation: Dual-Energy Computed Tomography (DECT)
Other Names:
Other: Ultrasound
Other Names:
Other: Transcranial doppler
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Ktrans on dynamic contrast-enhanced (DCE)-MRI [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 [1 day]
The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.
Secondary Outcome Measures
- deformation pattern on ultrasound [1 day]
The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.
- number of recorded micro embolic signals (MES) [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy
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Age 18 years or older (no maximum age)
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Informed consent by signing informed consent form regarding this study
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Inclusion criteria for carotid endarterectomy
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Symptomatic carotid artery stenosis 70-99% within 3 months of neurological symptoms
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Symptomatic carotid artery stenosis 50-99% in man within 2 weeks of neurological symptoms
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Asymptomatic carotid artery stenosis 70-99% with contralateral occlusion
Exclusion Criteria:
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Severe co-morbidity, dementia or pregnancy
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Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
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Patients who have a documented allergy to MRI or CT contrast media
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Patients with a renal clearance <30 ml/min are not eligible to undergo contrast-enhanced MRI
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Patients with a renal clearance <60 ml/min are not eligible to undergo CT
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Surgery planned within 4 days of inclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maastricht University Medical Center | Maastricht | Limburg | Netherlands |
Sponsors and Collaborators
- Maastricht University Medical Center
- Center for Translational Molecular Medicine
- Dutch Heart Foundation
Investigators
- Study Chair: Eline Kooi, PhD, Maastricht University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10-2-048