Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- coronary plaque progression
研究概览
简要总结
Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. The investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. In this project, the investigators aim to establish a well-characterized CHD cohort with comprehensive data collection, good compliance, and an appropriate sample size. By focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (IVUS), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with CAD and PCI was successfully performed.
- •Presence of non-target lesions near the target lesion (more than 5mm proximal or distal), with stenosis of 20% to 50% and identifiable anatomical markers (e.g., branches, calcifications, stent edges).
- •18 to 75 years old.
- •Written informed consent.
排除标准
- •Known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset.
- •Known familial hypercholesterolemia.
- •Critical conditions (e.g., cardiogenic shock, acute heart failure).
- •Severe renal insufficiency (eGFR < 30 mL /(min·1.73m2)), or severe hepatic insufficiency (ALT or AST≥3 times the upper limit of normal).
- •Severe underlying diseases (such as end-stage malignancies), life expectancy < 1 year.
- •Allergic to lipid-lowering medications.
- •Pregnant, or trying to become pregnant, and breastfeeding women.
- •Other conditions deemed unsuitable for inclusion by the researcher.
研究组 & 干预措施
CHD patients undergoing target lesion PCI
This study will enroll patients with CAD undergoing target lesion PCI, with appropriate non-target lesions near the target lesion, which served as the observed lesions
干预措施: Assessment of residual cholesterol and inflammatory risk factors (Diagnostic Test)
结局指标
主要结局
coronary plaque progression
时间窗: 9 to 12 months after PCI
percent change in plaque volume measured by IVUS
次要结局
- carotid plaque progression(9 to 12 months after PCI)
研究者
Chunfeng Dai
M.D.
Shanghai Zhongshan Hospital