Correlation Between Cerebral Microembolisation and Plaque Characteristics After Carotid Revascularization
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cerebral microembolisation
研究概览
简要总结
Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is recognized as an important outcome measure for carotid revascularization procedures such as carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation occurring during revascularization procedures is associated with an increased risk of peri- and post-procedural stroke, transient ischemic attack as well as neurocognitive decline. Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of myocardial infarction, cranial nerve palsy, and access site hematoma with CEA.
However little is known regarding the correlation between the morphological characteristics of the carotid plaque and the occurrence of microembolisation during the procedure and between microembolisation and midterm cognitive impairment. A few studies suggest that plaque morphology may be an important determinant for the increased risk of microembolisation. These studies however have mainly investigated microembolisation occurring during CAS and exploratory studies comparing the two procedures are still lacking.
The purpose of the present study is to determine the correlation between the morphological characteristics of the carotid plaque and cerebral microembolisation either after carotid stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting a symptomatic (ipsilateral ischemic stroke, TIA located in the carotid artery territory or retinal ischemia) carotid stenosis between 50% and 99% (according to NASCET and ECST criteria)
- •Patients presenting an asymptomatic carotid stenosis between 60% and 99% (according to NASCET and ECST criteria) Patients who accept the informed consent
排除标准
- •Important neurological deficit with NIHSS >7 (or severe aphasia) at time of inclusion
- •Previous known cognitive impairment
- •Pregnancy
- •Presence of contraindication based on ground of multidisciplinary team decision:
- •For surgery:
- •High bifurcation Intracranial extension of the carotid stenosis Patients with tandem lesions High suspicion of severe siphon stenosis Patients with previous irradiation of the cervical region Patients with restenosis after endarterectomy
- •For stenting; Excessive arch vessel or carotid artery tortuosity and in particular presence tortuosity ≤90 degrees in the cervical segment Excessive aortic arch plaque burden Patients older than 70 years Unfavourable anatomic disposition as described above Co-morbidities that may preclude the use of a periprocedural dual antiplatelet regime.
- •For CT-scan Iodine allergy Renal insufficiency
- •For MRI Pacemaker Any other metallic implants Claustrophobia
- •For ultrasound Bad quality ultrasound (patient morphology or equipments
结局指标
主要结局
Cerebral microembolisation
时间窗: 24 hours
the presence of at least 1 new hyperintense DWI lesion on the MRI realized within the 24 hours after procedure and will be correlated to the different characteristics of the carotid plaque evaluation.
次要结局
- Neuropsychological assessment(3 months)
研究者
Loraine Fisch
Principal investigator
University Hospital, Geneva