Neuroimaging Correlates of Memory Decline Following Carotid Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Brain MRI scans
研究概览
简要总结
Carotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Characterizing risk factors for cognitive decline following carotid interventions and individualizing treatment strategy based on those risks can minimize procedure-associated cognitive dysfunction. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this protocol, we hope to determine how cerebral blood flow and baseline white matter abnormality in the vulnerable region modify the frequency and cognitive effect of microembolization following carotid revascularization procedures.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is male or female >40 yrs of age.
- •Patient has occlusive extracranial carotid stenosis (≥70%)
- •Patient is scheduled to undergo a carotid revascularization procedure
- •Patient agrees to voluntarily participate in the study and signs an informed consent.
- •Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
- •Patient has sufficient visual and auditory acuity for cognitive testing.
排除标准
- •Patient is unable to safely and comfortably undergo MR imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
- •Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
- •Patient has prominent suicidal or homicidal ideation.
- •Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
- •Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
- •Patient has prior closed head injury with ≥24 hours of amnesia.
结局指标
主要结局
Brain MRI scans
时间窗: 6 months following the procedure
White matter abnormality and perfusion in correlation with microembolization and cognitive change
次要结局
未报告次要终点