Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 主要终点
- Carotid B-Mode Ultrasound
研究概览
简要总结
The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use
详细描述
Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been investigated in clinical use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 43 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) carotid ultrasound examination: presence of carotid plaque or abnormal CIMT of between 0.9 and 1.2mm; (2) lipid profile: LDL≦3.12mmol/L, TC≦5.2mmol/L; (3) no lipid-lowering treatment within the past 6 months.
排除标准
- •severe cardiomyopathy, acute coronary syndrome, hepatic dysfunction, end-stage renal failure (serum creatinine ≥117mmol/L), prior carotid endarterectomy, and/or patients who did not agree to participate in the present study.
研究组 & 干预措施
GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
干预措施: lifestyle intervention (Other)
control group
In the control group, all patients were enrolled in a lifestyle intervention
干预措施: lifestyle intervention (Other)
GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
干预措施: GSPE (Drug)
结局指标
主要结局
Carotid B-Mode Ultrasound
时间窗: Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.
The common, internal, and external carotid arteries were carefully identified by combining B-mode ultrasonography and color-Doppler duplex examination in the anterior oblique, lateral, and posterior oblique planes. All data was collected in 12 segments: the near （intimal-luminal surface) and far (medial- adventitial) walls of the distal common (1 cm proximal to dilation of the carotid bulb), the bifurcation (1cm proximal to the flow divider), and the proximal internal (1 cm section of the internal carotid artery immediately distal to the flow divider) left and right carotid artery.
次要结局
- clinical vascular events(after 24 months follow-up)
研究者
Jie Qiu
Qilu Hospital of Shandong University
Shandong University