Evaluation of Small Vessel Disease by 3D-rotational Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Morphological change
研究概览
简要总结
This study is aimed to elucidate the factors affecting the remodeling process of arteriolosclerosis under current practice recommendations. Such knowledge may improve the understanding of cerebral small vessel disease (cSVD) mechanism, define pharmacological therapy and suggest treatment target.
详细描述
Around 68 patients who have acute cerebral ischemic symptoms attributed by cSVD will be recruited. Stroke etiology will be determined by Neurologists based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks. The time window for recruitment is 4 weeks from the qualifying stroke.
After an informed consent for the study, potential candidates will undergo a cranial MRI and MR angiography. Patients who are found to have acute or subacute lacunar infarcts (defined as an infarct diameter < 15mm) in the territories supplied by the lateral lenticulostriate arteries, i.e. internal capsule, putamen, external capsular or corona radiata, will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive single antiplatelet agents and statin. Their cognition, mobility and treat cardiovascular risk factors based on 4 pre-specified goals (as elaborated in Study Procedures) will also be regularly reviewed.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is Chinese ONLY
- •Patient is 30 to 85 years of age, inclusive.
- •Patients who have an acute lacunar infarct in diffusion-weighted MRI compatible with small vessel disease in territories supplied by the lateral lenticulostriate arteries without relevant intracranial atherosclerotic stenosis ≥60%.
- •Patient who has no contra-indication for the proposed imaging tests.
- •Patient who understands the purpose and requirements of the study, and has an informed consent.
- •Patient who has Modified Functional Ambulation Classification 4 or above.
排除标准
- •Stroke etiology uncertain or unrelated to small vessel disease, such as cardioembolism, Moyamoya disease, ICAD or primary angiitis of CNS.
- •Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets <100 x 109/L), coagulopathy (INR >1.5).
- •A medical condition that would not allow the patient to adhere to the protocol or complete the study.
- •Patients with severe renal impairment.
- •Patients who are taking warfarin and non-vitamin K antagonist oral anticoagulants would also be excluded.
研究组 & 干预措施
Stroke patient
Patients who have acute cerebral ischemic symptoms attributed by cSVD can be recruited into this study. Eligible patients will be screened by Neurologists based on the inclusion and exclusion criteria. The time window for recruitment of the patient is 4 weeks from the qualifying stroke.
结局指标
主要结局
Morphological change
时间窗: one year after recruitment
The pre and post imaging in ischemic stroke patients by 3D-rotational angiography
次要结局
未报告次要终点
研究者
Dr. IP Yiu Ming Bonaventure
Specialist resident
Chinese University of Hong Kong