AtheroGEnic LipoprotEinS in Ischemic Stroke: The AGELESS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Presence of an ischemic, hemispheric, ipsilateral stroke on baseline brain MR-Diffusion Weighted Imaging (DWI)
研究概览
简要总结
Apolipoprotein B (apoB) levels (which encompass all atherogenic lipoproteins, including LDL), Lp(a) levels, and carotid IPH are associated with both first-ever and recurrent ischemic stroke.
This cohort research project is to analyze:
- Among patients with carotid artery atherosclerosis (stenosis 30-99%), to compare patients with and without IPH, as assessed by magnetic resonance (MR)-Plaque Imaging, in terms of apoB, Lp(a) levels and other cardiovascular risk factors. (IPH is a strong morphological sign of plaque vulnerability / instability and a strong marker of consecutive atheroembolic events).
- Among patients with carotid artery atherosclerosis (stenosis 30-99%), to assess the risk of first-ever ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors (understanding this association can inform primary prevention).
- Among patients with carotid artery atherosclerosis (stenosis 30-99%) with an ipsilateral ischemic stroke at baseline, to assess the risk of recurrent ipsilateral ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors. There will be a sensitivity analysis to assess if the association between Lp(a) and recurrent stroke is stronger in patients <60 years of age. (understanding this association can inform secondary prevention).
For the first and second aim, there will be a cross-sectional, case-control analysis. For the third aim, i.e. assessing recurrent ischemic stroke, there is prospective follow-up of at least 3 months up to 45 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atherosclerotic carotid stenosis, North American Symptomatic Trial Collaborators (NASCET) method 30-99%
- •Ability to undergo a neck MR for carotid plaque imaging
- •Ability to undergo a follow-up of at least 1-year
- •For the prospective, longitudinal part: Hemispheric ischemic stroke or retinal ischemia ipsilateral to the carotid stenosis, with symptom onset within 24 hours (these patients will be followed-up for recurrent ischemic stroke)
排除标准
- •Carotid stenosis due to causes other than atherosclerosis (e.g. carotid dissection or post-actinic)
- •Contraindication to MRI
- •Lack of informed consent
结局指标
主要结局
Presence of an ischemic, hemispheric, ipsilateral stroke on baseline brain MR-Diffusion Weighted Imaging (DWI)
时间窗: one time assessment at baseline
Presence of an ischemic, hemispheric, ipsilateral stroke, i.e. on the same side of the carotid stenosis, on baseline brain MR-DWI.
Presence of a recurrent ischemic, hemispheric, ipsilateral stroke in the 3-month follow-up brain MR-DWI
时间窗: 3 months after baseline
Presence of a recurrent ischemic, hemispheric, ipsilateral stroke in the 3-month follow-up brain. The 3-month follow-up brain MR-DWI is conceived to detect covert strokes, i.e. clinically asymptomatic strokes, as recurrences tend to occur short after the first stroke.
Presence of carotid IPH on MR-Plaque imaging (3-Tesla MR scans with an 8-channel carotid coil)
时间窗: one time assessment at baseline (scan time is 5 minutes)
Presence of carotid IPH on MR-Plaque imaging at baseline. Baseline means either acquired during the hospitalization for the index stroke or during the enrolling visit at the outpatient consultation of the neurovascular clinic of the University Hospital Basel (primary center) and Zurich (partner center).
次要结局
未报告次要终点