The Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- MACCE
研究概览
简要总结
Coronary artery disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular and cerebrovascular events (MACCE). At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Previous studies indicated that hsCRP ≥ 2mg / L was the definition standard of RIR in CAD in European and American people. In China, the impact of dynamic changes of hsCRP and other inflammatory factors on MACCE in PCI population remains unclear. Therefore, in this study, the investigators plan to recruit patients undergoing PCI, and observe the impact of hsCRP and other inflammatory factors on the prognosis of these patients during long term follow-up at 17 hospitals in China.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who understand and sign the informed consent voluntarily;
- •Age ≥ 18 years old and ≤ 80 years old, regardless of sex;
- •The hospitalized patients with coronary heart disease undergoing PCI;
- •Complete all planned PCI during hospitalization.
排除标准
- •Acute, chronic or recurrent infectious diseases;
- •Immune diseases or immune-related diseases;
- •Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapy drugs;
- •Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive measures;
- •The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
结局指标
主要结局
MACCE
时间窗: 12 months
A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization
次要结局
- cardiovascular death(12 months)
- nonfatal stroke(12 months)
- ischemia-driven revascularization(12 months)
- in-stent restenosis(12 months)
- nonfatal myocardial infarction(12 months)
- bleeding(12 months)
- all-cause death(12 months)
- hospitalization for unstable angina(12 months)
- stent/scaffold thrombosis(12 months)
研究者
Xiang Cheng
Director of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan Union Hospital, China