Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Morphologic Evolution and Remodeling of Intracranial Atherosclerosis
研究概览
简要总结
This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent control of cardiovascular risk factors.
详细描述
The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound, CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (<3mm) angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy from a near-infinite number of planes, analyzing the stroke mechanisms and morphological changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to time sequence will measure the geometric parameters and the luminal narrowing by WASID method.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 30 to 85 years of age, inclusive.
- •Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism and a relevant intracranial atherosclerotic stenosis ≥60%.
- •Patient who has no contra-indication for the proposed imaging tests.
- •Patient understands the purpose and requirements of the study, and has provided an informed consent.
排除标准
- •Patient with any of the following conditions would be excluded:
- •Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.
- •A tandem stenosis >50% at extra-cranial internal carotid artery.
- •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.
研究组 & 干预措施
Symptomatic stroke patient
Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery (stenosis >60%) will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive dual antiplatelet agents for 4 weeks, followed by aspirin alone. The investigator or neurologists shall regularly review the patients and treat the conventional cardiovascular risk factors based on four pre-specified goals, for example, LDL <1.8, HbA1c <6.0, blood pressure <140/90 and no smoking. The morphologic changes of the cerebral plaques with the intensity of the risk factor control in pre and post will be correlated.
干预措施: 3DRA (Diagnostic Test)
结局指标
主要结局
Morphologic Evolution and Remodeling of Intracranial Atherosclerosis
时间窗: Dec, 2019
The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.
次要结局
未报告次要终点
研究者
Leung Wai Hong Thomas
Professor
Chinese University of Hong Kong