A Pilot Study Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia in Clinical Routine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change of mean carotid vessel wall fractional anisotropy (2-Dimensional Cardiovascular Magnet Resonance) by very potent lipid-therapy intensification with Alirocumab
研究概览
简要总结
A prospective, open-label, pilot study with 24 cardiovascular high risk patients (N=24) having insufficient Low density lipoprotein cholesterin (LDL-C) reduction despite standard of care lipid-modifying therapies (LMTs), to evaluate the effects of potent lipid-therapy intensification via the recently approved monoclonal, human anti-PCSK9 antibody Alirocumab on endothelial function, inflammation, lipoprotein particle subfractions, carotid arteries and post-prandial lipemia in clinical routine at the Medical University of Graz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient scheduled for treatment with Alirocumab in clinical routine (after approval of cost coverage by insurance company)
- •No previous treatment with PCSK9 antibodies
- •Signed informed consent form
排除标准
- •Age of < 18 years
- •Pregnancy (pregnancy test at screening visit)
- •Breast-feeding
- •Impossibility to perform magnetic resonance imaging of the carotid artery (claustrophobia, carotid stent)
结局指标
主要结局
Change of mean carotid vessel wall fractional anisotropy (2-Dimensional Cardiovascular Magnet Resonance) by very potent lipid-therapy intensification with Alirocumab
时间窗: From baseline to 10 weeks of treatment
Study participants will undergo a cardiovascular magnetic resonance imaging of the carotid vessels. High resolution diffusion tensor imaging (DTI) will be performed on one selected axial slice using read-out segmented EPI (rs-EPI) sequence on a 3T MR scanner.
次要结局
- Change of FDD (flow-dependent dilation) in response to Alirocumab(From baseline to 10 weeks of treatment)
- Change of intima media thickness in response to Alirocumab(From baseline to 10 weeks of treatment)
- Change of post-prandial lipaemia in response to Alirocumab(From baseline to 10 weeks of treatment)
- Change of the lipoprotein subfractions in response to Alirocumab(From baseline to 10 weeks of treatment)
- Changes of inflammatory parameters in response to Alirocumab(From baseline to 10 weeks of treatment)