Long-term Neurocognitive Sequelae of Subclinical Microembolization During 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
- 3
- 主要终点
- Incidence of microemboli in correlation with changes in neurocognitive assessment performance
研究概览
简要总结
Microembolization is commonly associated with carotid artery stenting (CAS), but our understanding of subclinical microembolization is superficial. Through collaborative effects of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to better understand the clinical significance and long-term cognitive effects of microemboli. This proposal may change our current clinical practice by providing a better outcome measure for carotid interventions and improving outcomes of CAS procedures through risk factor stratification. Our central hypothesis is that development of subclinical microemboli is associated with decline in cognitive function following CAS and that the risk of development of microemboli themselves is associated with patient- and procedure-related factors. We hope that this prospective study will help to clarify these important issues in the era of rapidly evolving percutaneous interventions.
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 an endovascular intervention of a lesion in the extracranial carotid artery
- •Patient agrees to voluntarily participate 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 magnetic resonance 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.
- •Patient is unable to understand or sign the informed consent.
结局指标
主要结局
Incidence of microemboli in correlation with changes in neurocognitive assessment performance
时间窗: 1 year following CAS procedure
次要结局
- Risk factor stratification for incidence of microemboli(1 year following CAS procedure)