Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT)Combined With Intravascular Ultrasound (IVUS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS.
研究概览
简要总结
Many trials suggested that lipid lowering therapy could significantly reduce cardiovascular events. Enhancing stability of vulnerable plaque is probably the main reason by which statins reduce adverse coronary events. The size of lipid core and the fibrous cap thickness (FCT) are the major determinants of plaque vulnerability. So, it is very important to accurately evaluate changes in plaque after stains therapy.
Previous reports suggested that intensive lipid lowering therapy provide more significantly clinical benefit compared with moderate lipid lowering therapy.Such benefit may contribute to the changes in following parameters: FCT, lipid arc(quadrants), TCFA, macrophage, plaque disruption, and thrombus measured by OCT, and plaque burden and remodeling index by IVUS.
Current intravascular imaging modalities, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS) can provide in vivo quantitative and qualitative information of coronary plaques. However, there were few studies aimed at monitoring the progression of coronary plaques in patients receiving statin therapy by OCT combined with IVUS.
Therefore, the study we designed were to compare the effect of the rosuvastatin 10mg, atorvastatin 20mg and atorvastatin 60mg treatment on the changes in FCT and lipid core arc by OCT and plaque burden by IVUS of coronary atherosclerotic plaques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age :18-75Y
- •Clinical indication for coronary angiography (CAG).
- •CAG demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20% and 70% (visual estimation).
- •OCT demonstrates the lesion is a lipid-rich plaque (FCT ≤200μm and lipid arc ≥100o).
- •LDL-C range between 70mg /dl and 160mg /dl.
- •Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
- •Exclusion criteria:
- •Life expectancy <12 months due to another medical condition.
- •Contraindication to the atorvastatin and rosuvastatin.
- •Creatinine levels more than 2.0mg/dL or ESRD.
- •Severe hepatic dysfunction (AST and/or ALT more than 3 times the upper limit of normal).
- •Congestive heart failure (left ventricle eject fraction ≤35%).
- •Female of childbearing potential with a positive pregnancy test within 7 days before study, or lactating, or intends to become pregnant during the following 12 months.
- •The patient is likely to require coronary bypass surgery, cardiac transplantation, surgical repair or replacement during the course.
- •Exit criteria
- •ALT/AST ≥ 3times upper limit of normal after enrollment.
- •Muscle ache/myopathy.
- •Lose follow-up.
- •Patient insists on exit.
排除标准
- 未提供
研究组 & 干预措施
Group A:
Atorvastatin 20mg
干预措施: Atorvastatin (Drug)
Group B:
Atorvastatin 60mg
干预措施: Atorvastatin (Drug)
Group C:
Rosuvastatin 10mg
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS.
时间窗: 12 months after enrollment
次要结局
- To investigate the changes of FCT assessed by OCT and plaque burden by IVUS in comparisons of atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg.(12 months)
- To investigate the changes of remodeling index assessed by IVUS in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg(12 months)
- To investigate the changes of macrophage infiltration semi-quantitatively by OCT in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg(12 months)
研究者
Yu Bo
Bo Yu ,President, Department of Cardiology
Harbin Medical University