Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the main indicator
研究概览
简要总结
In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. The specific indicators included retinal microvessel diameter, macular area，optic disc vascular density and FAZ(Foveal Avascular Zone)area, etc., to clarify the effect of evolocumab on retinal microvessels after intensive lipid-lowering therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-75 years old, gender unlimited;
- •Diagnosed as coronary atherosclerotic heart disease
- •The informed consent for the study has been signed
排除标准
- •Those who are unable to cooperate with the examination;
- •Poor imaging quality of refractive interstitial opacity;
- •Macular edema or complicated with macular membrane and senile macular degeneration;
- •Have a history of previous fundus surgery;
- •Those with eye diseases that can cause changes in the microvessels of the fundus;
- •Abnormal elevated intraocular pressure;
- •Moderate or above refractive error (≥ ± 3 diopters)
- •People with cognitive impairment, material dependence, and serious mental illness;
- •Those who do not cooperate with follow-up;
- •Those who participate in other clinical trials at the same time
研究组 & 干预措施
Experimental Group
evolocumab combined with statins
干预措施: Evolocumab combined with statins (Drug)
Control Group
statins only
干预措施: Statin (Drug)
结局指标
主要结局
the main indicator
时间窗: Up to 12 months
Video disc area (4.5 × 4.5 mm2) of the radial capillary network (RPC) around the nipple and the macular area (6 × 6 mm2), superficial retinal vascular plexus (SCP) and deep retinal vascular plexus (DCP).
次要结局
- the secondary indicator(Up to 12 months)
研究者
Bo Li
Clinical Professor；Department of Cardiology, Zibo Central Hospital
Zibo Central Hospital