Evaluation of Antithrombotic STrategies in STEMI Patients in China
试验速览
- 阶段
- 不适用
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Net Adverse Clinical Events (NACEs)
研究概览
简要总结
EAST-STEMI is the first perspective, multicenter, large-scale registry focusing on the evaluation of real-world medical quality (especially PCI quality) and antithrombotic strategies in STEMI patients undergoing emergent PCI in a regional representative sample in China with 2 years follow-up. Clinical decision support tools (including ischemic score, bleeding score, etc) will be developed and validated based on the database. Novel biomarkers to predict the prognosis and to support risk stratification will be explored by using the blood samples.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>=18yrs
- •STEMI patients undergoing emergent PCI
- •Signed informed consent
排除标准
- •Difficult to follow up or obtain accurate information (e.g., long-term overseas stay, speech or mental disorders)
- •Other severe diseases (e.g., liver failure, renal failure and advanced stage of cancer)
结局指标
主要结局
Net Adverse Clinical Events (NACEs)
时间窗: 2 years after emergent PCI
The primary outcome is the rate of adjudicated NACEs, a composite of major adverse cardiac or cerebral events (MACCEs) and bleeding. MACCEs include cardiac death, reinfarction, urgent revascularization, or stroke. Bleeding is defined by the Bleeding Academic Research Consortium (BARC) definition (types 1-5). BARC type 2 bleeding is considered as minor bleeding, type 3-5 bleeding is considered as major bleeding.
次要结局
- Quality of life (QoL)(2 years after emergent PCI)
- Contrast-induced acute kidney injury (CI-AKI)(72 hours after contrast exposure)
- Definite/Probable Stent thrombosis(2 years after emergent PCI)
- Heart failure(2 years after emergent PCI)