Symptomatic Carotid Outcomes Registry With Multi-center Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 114
- 试验地点
- 18
- 主要终点
- Ischemic stroke
研究概览
简要总结
The purpose of this study is to build upon trials done over 30 years ago, which did not include statins, new antiplatelet agents, and newer antihypertensive medications. Since the landmark trials (NASCET, ECST), there have been new developments in medical stroke prevention, which creates a gap in knowledge. The aim of this study is to evaluate that clinical care with Intensive Medical Therapy (IMT) alone, the one year stroke rate in patients with symptomatic carotid stenosis and low risk clinical features will be <5%.
详细描述
This study will only be evaluating clinical care and no interventions will be done specifically for this research.
- Informed consent from patient or legally authorized representative.
- Participant survey/questionnaire completion at baseline, 6 and 12 months after enrollment
- All data collected will be entered into a secure research data registry created for this study.
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
- 否
入选标准
- •Age ≥40 years plus stroke or TIA ipsilateral to 50-99% ICA stenosis
- •In addition, patients must have at least one clinical or radiologic marker of reduced stroke risk
- •Clinical Reduced Stroke RISK:
- •Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
- •Most recent stroke or TIA >1 week ago
- •Radiologic Reduced Stroke RISK:
- •Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
- •Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
- •For patients with TIA: brain MRI shows no DWI lesion
排除标准
- •Atrial fibrillation or other high-risk sources of cardiac embolism unless it is device detected AF only or duration <6 minutes
- •Alcohol and substance abuse within the prior 24 months
- •Clinically significant bleeding diathesis (platelet count <100K, prothrombin time >14 seconds)
- •Clear indication for therapeutic anticoagulation (for example, DVT or pulmonary embolism within past 3 months)
- •Left ventricular ejection fraction <20%
- •Known allergy or intolerance to aspirin or clopidogrel
- •Life expectancy less than 12 months
- •Moderate/severe dementia (Mini-mental or MOCA score <22
- •Modified Rankin score of >4
- •Nonatherosclerotic cause of carotid stenosis
- •Most recent symptomatic event >180 days from the time of enrollment
结局指标
主要结局
Ischemic stroke
时间窗: within 12 months
ipsilateral to carotid stenosis, with radiologic confirmation
次要结局
- Myocardial infarction(within 12 months)
研究者
Seemant Chaturvedi
Professor of Neurology
University of Maryland, Baltimore