Prognostic Value of Carotid Contrast-Enhanced Ultrasound in Acute Ischemic Stroke Patients for Cerebrovascular and Cardiovascular Event
试验速览
- 阶段
- 不适用
- 入组人数
- 667
- 试验地点
- 1
- 主要终点
- Composite of recurrent stroke, vascular death and myocardial infarction
研究概览
简要总结
Contrast-enhanced ultrasound(CEUS) of carotid artery plaque is a novel method that enabled direct visualization of neovessels in the vulnerable plaque. Plaque enhancement with CEUS showed correlation with the histologic density of neovessels within the carotid plaque and the previous cardiovascular events. Vulnerable plaques with a high risk of thromboembolic complications and rapid progression is associated with acute ischemic stroke. The prognostic value of vulnerable carotid artery plaque depicted with CEUS has not been fully investigated. The purpose of this study is to define prognostic value of plaque enhancement on carotid CEUS in acute stroke patients. Research question is; in acute ischemic stroke patients with ipsilateral carotid plaque as probable etiology of stroke, is the presence of carotid plaque enhancement on CEUS independent predictor of future stroke.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 19 years presenting acute ischemic stroke.
- •Compatible neurologic symptom within 14 days
- •Compatible MRI finding (one or more positive DWI lesions in the territory of unilateral ICA: ACA or MCA territory) - interpretable MRI image obtained in SNUBH or outside hospital
- •Etiology of acute ischemic stroke: except cardioembolic stroke (Atrial fibrillation) and other determined etiology
- •Ipsilateral extracranial carotid artery stenosis on MRA (CE-MRA), CTA or Doppler ultrasound
排除标准
- •History of ipsilateral carotid stent or endarterectomy
- •Carotid intervention during hospital stay
- •Contraindication to ultrasound contrast agent (SonoVue) A. Right to left, bi-directional, or transient right to left cardiac shunts B. History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or any ultrasound contrast agent C. Pregnant or lactating woman D. Unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening congestive heart failure, or serious ventricular arrhythmias)
- •Expected life span less than 12 months
结局指标
主要结局
Composite of recurrent stroke, vascular death and myocardial infarction
时间窗: 12 months
(1) recurrent stroke: newly appeared DWI positive lesion on brain MRI with corresponding neurologic symptom (2) vascular death: sudden death, death due to stroke, myocardial infarction, heart failure, arrhythmia, pulmonary embolism, systemic bleeding, or ischemia of organ. (3) myocardial infarction: at least two of the followings: ① a history of typical angina pain. ② Elevation of Troponin, ③ Newly developed ST change or Q waves or LBBB on ECG (outcomes will be measured by chart review or physician diagnosis or telephone interview)
次要结局
- All-cause mortality(12 months)
- Ipsilateral stroke(12 months)
- Carotid intervention(12 months)
研究者
Yeo Koon Kim
Assistant Professor
Seoul National University Hospital