Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pre-operative neuropsychological state
研究概览
简要总结
In this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will also be gathered. The mix of these data will allow us to answer several questions regarding the absence or presence of preoperative impairments, postoperative changes in cognitive performance and possible differences between CEA and CAS regarding postoperative neuropsychological functions. The use of a matched control group and implementation of a long term follow-up will contribute to the uniqueness of this study. It will meet several flaws of previous studies and will complete the ongoing randomized studies comparing CEA and CAS that are lacking neuropsychological data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with carotid stenosis.
排除标准
- •Significant medical conditions which affect neurocognitive functions (e.g. cancer, epilepsy)
- •Older than 80 years
- •A history of psychiatric or neurological illness
- •Severe alcohol of drug abuse
- •Coronary artery bypass graft (CABG) less than a year ago.
研究组 & 干预措施
Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
干预措施: Neurocognitive functions (Procedure)
Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
干预措施: Carotid endarterectomy (CEA) (Procedure)
Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
干预措施: Levels of biomarkers (Procedure)
Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
干预措施: Detection of peri-operative embolization (Procedure)
Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
干预措施: Validation results (Procedure)
matched control group
Matched control group.
Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
干预措施: Neurocognitive functions (Procedure)
Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
干预措施: Levels of biomarkers (Procedure)
Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
干预措施: Detection of peri-operative embolization (Procedure)
Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
干预措施: Validation results (Procedure)
Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
干预措施: Carotid stenting (CAS) (Procedure)
结局指标
主要结局
Pre-operative neuropsychological state
时间窗: pre-operative
Pen and paper tests will be performed.
Post-operative neuropsychological state (3 weeks)
时间窗: after 3 weeks
Pen and paper tests will be performed.
Post-operative neuropsychological state (6 months)
时间窗: after 6 months
Pen and paper tests will be performed.
Post-operative neuropsychological state (1 year)
时间窗: after 1 year
Pen and paper tests will be performed.
次要结局
- Clinical neurological examination after 6 months(after 6 months)
- Levels of biomarkers pre-operatively(pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours)
- Determination of cardiovascular risks pre-operatively(pre-operatively)
- Determination of cardiovascular risks after 3 weeks(after 3 weeks)
- Determination of cardiovascular risks after 6 months(after 6 months)
- Determination of cardiovascular risks after 1 year(after 1 year)
- Clinical neurological examination after 3 weeks(after 3 weeks)
- Peri-operative embolization(Peri-operative)
- Validation results(pre- and post-operative after 48 hours and 3 weeks)
- Clinical neurological examination after 1 year(after 1 year)