The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lipid-rich necrotic core on dual-energy CT
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy
- •Age 18 years or older (no maximum age)
- •Informed consent by signing informed consent form regarding this study
- •Inclusion criteria for carotid endarterectomy
- •Symptomatic carotid artery stenosis 70-99% within 3 months of neurological symptoms
- •Symptomatic carotid artery stenosis 50-99% in man within 2 weeks of neurological symptoms
- •Asymptomatic carotid artery stenosis 70-99% with contralateral occlusion
排除标准
- •Severe co-morbidity, dementia or pregnancy
- •Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
- •Patients who have a documented allergy to MRI or CT contrast media
- •Patients with a renal clearance <30 ml/min are not eligible to undergo contrast-enhanced MRI
- •Patients with a renal clearance <60 ml/min are not eligible to undergo CT
- •Surgery planned within 4 days of inclusion
结局指标
主要结局
Lipid-rich necrotic core on dual-energy CT
时间窗: 1 day
The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.
Ktrans on dynamic contrast-enhanced (DCE)-MRI
时间窗: 1 day
The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.
次要结局
- deformation pattern on ultrasound(1 day)
- Volume of LRNC and calcifications and fibrous cap status on MRI(1 day)
- number of recorded micro embolic signals (MES)(1 day)