Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in cognitive score
研究概览
简要总结
The majority (>80%) of strokes are of ischemic etiology, of which ≈15% to 20% are attributable to atherosclerosis of the extracranial carotid arteries. The primary goal in carotid artery revascularization is to prevent stroke in patients with carotid artery stenosis. Treatment options including carotid endarterectomy (CEA) and carotid artery stenting (CAS). Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications and carotid artery restenosis. Finally, long-term and sustained cognitive benefits after carotid artery revascularization need further research and evidence.
详细描述
Hypothesis and Significance: We hypothesize that hemodynamically changes after carotid artery revascularization influence the cerebral function or carotid artery patency. If cognitive improvement or impairment and carotid artery restenosis can be demonstrated relate to hemodynamic remodeling in these patients, then we will have established a new prognostic factor for carotid revascularization independent of the existing study.
Specific Aim: 1) To compare the impact of carotid artery revascularization on long-term post-operative baroreceptor function and on cognitive brain function, and analyze their influence on clinical outcome. The specific goal is to assess the potential correlation between post-operative autonomic and cognitive function.
- To assess the solicitation on the carotid wall due to CAS as compared to CEA through structural analysis and mechanical modeling. The specific goal is to assess the potential correlation between stenting, wall damage, baroceptor impairment, and late neurological sequelae. 3) To assess the post-operative carotid hemodynamics combining medical image analysis, clinical data, and computer simulations. The specific goal aims at correlating both local (e.g., wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RRT)) and global phenomena (controlateral flow, arterial stiffening) with baroreflex function and post-operative neurological outcomes.
Cognitive Assessment. HALO will use existing cognitive assessment infrastructure. Cognitive assessments in our study must take place prior to revascularization or within two weeks after assignment to medical therapy alone. Testing is repeated at 44 days, and every year thereafter up to 4 years. At each test interval, a composite (mean) Z-score is derived from published normative samples for each test outcome. The primary outcome will be at 1 year in which the change in the composite Z-score from baseline will be calculated. Covariates will include age, education and depression. The test battery will be administered the same way for all enrolled patients. The cognitive domains being assessed in HALO are entirely consistent with those encompassed within the NINDS Common Data Elements (CDE).
Imaging protocol. Multimodal MRI, including routine parenchymal sequences and PWI utilizing dynamic susceptibility contrast technique, will be acquired at each participating HALO site. Imaging will take place within 14 days after HALO enrollment and prior to any intervention (carotid artery revascularization).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed Patients with >=70% symptomatic or >=80% asymptomatic internal carotid stenosis
排除标准
- •Incapability to give informed consent Previous disabling stroke Contralateral carotid occlusion or >70% stenosis Systemic disease judged non compatible with the procedures or randomization Suspected or manifested pregnancy General contraindications to MRI or CT studies
结局指标
主要结局
Change in cognitive score
时间窗: 1 year
Among those with flow failure (PWI "time to peak" (TTP) delay\>2 sec) and cognitive impairment (\>1.0 SD below age-matched norms) at baseline, cognitive change at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Change in carotid stenosis
时间窗: 1 year
The stenosis of the carotid artery measured by contrast-enhanced CT will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Change in oscillatory shear index (OSI)
时间窗: 1 year
The hemodynamics factors: oscillatory shear index (OSI) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Change in wall shear stress(WSS)
时间窗: 1 year
The hemodynamics factors: wall shear stress (WSS) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Change in relative residence time(RRT)
时间窗: 1 year
The hemodynamics factors: relative residence time (RRT)) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
次要结局
- Silent infarcts(1 year)
- Major adverse cardiovascular events(1 year)
- White matter hyperintensity (WMH) volume(1 year)
- The mortality rate(1 year)
