Trends and Risk Factors of Major Adverse Cardiovascular and Cerebrovascular Events After Primay Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Long-Term Follow-Up Study Based on Hospital Real-World Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
研究概览
简要总结
This single-center, ambispective cohort study will use real-world data from Zhongshan Hospital, Fudan University. About 8,000 patients aged 18 years or older with acute myocardial infarction (AMI) who underwent primary percutaneous coronary intervention (PCI) from 2009 to 2028 will be included. Patients will be grouped into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. The study aims to describe 20-year trends in in-hospital events and major adverse cardiovascular and cerebrovascular events (MACCE) within 2 years after PCI and to identify independent risk factors. The primary outcome is MACCE within 2 years, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. Key secondary outcomes include in-hospital all-cause death, impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events. Data will come from electronic medical records and the cardiac catheterization database.
详细描述
Background: Acute myocardial infarction (AMI) is a leading cause of cardiovascular death in China. Primary PCI improves outcomes, but patients remain at risk of in-hospital events and long-term major adverse cardiovascular and cerebrovascular events (MACCE). Long-term real-world evidence from China is limited.
Design: This single-center, ambispective cohort study will include about 8,000 AMI patients aged 18 years or older treated with primary PCI at Zhongshan Hospital, Fudan University, from 2009 to 2028. Patients will be divided into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. Follow-up will be 2 years after PCI or until an endpoint event, death, or loss to follow-up.
Objectives: To describe the incidence and 20-year trends of in-hospital events and 2-year MACCE, and to identify independent risk factors.
Outcomes: The primary outcome is 2-year MACCE, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. The key secondary outcome is in-hospital all-cause death. Other secondary outcomes include impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events.
Data and Analysis: Data will be obtained from electronic medical records and the cardiac catheterization database. Retrospective data will be collected for 2009-2026, with prospective enrollment for 2027-2028. Descriptive analysis, Kaplan-Meier method, log-rank test, Cox proportional hazards models, and logistic regression will be used. Subgroup and sensitivity analyses will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Hospitalized at Zhongshan Hospital, Fudan University, with a diagnosis of acute myocardial infarction (AMI) according to the Universal Definition of Myocardial Infarction, between January 1, 2009, and December 31,
- •Underwent primary percutaneous coronary intervention (PCI) during hospitalization (within 12 hours of symptom onset, or beyond 12 hours with persistent evidence of ischemia).
- •Aged 18 years or older at the time of PCI.
- •Informed consent obtained, or criteria for waiver of informed consent.
排除标准
- •Inability to tolerate PCI, or unsuccessful PCI.
- •Concomitant malignancy with an expected survival of less than 1 year.
- •Pregnant or breastfeeding women.
- •Missing data for key variables exceeding 30%, which would prevent valid analysis.
- •Any other condition that, in the investigator's opinion, precludes participation.
研究组 & 干预措施
AMI patients undergoing primary PCI
Acute myocardial infarction patients undergoing primary PCI
干预措施: Collection of baseline characteristics (Other)
结局指标
主要结局
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
时间窗: Within 2 years after PCI
Composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. The first occurrence of any component will be used for time-to-event analysis.
次要结局
- In-hospital all-cause death(Perioperative/Periprocedural)
- In-hospital impaired myocardial perfusion(At the end of the PCI procedure)
- In-hospital malignant arrhythmia(Perioperative/Periprocedural)
- In-hospital acute heart failure(Perioperative/Periprocedural)
- In-hospital recurrent myocardial infarction(Perioperative/Periprocedural)
- In-hospital non-fatal ischemic stroke(Perioperative/Periprocedural)
- All-cause death within 2 years after PCI(Within 2 years after PCI)
- Cardiovascular death within 2 years after PCI(Within 2 years after PCI)
- Recurrent myocardial infarction within 2 years after PCI(Within 2 years after PCI)
- Ischemia-driven repeat revascularization within 2 years after PCI(Within 2 years after PCI)
- Non-fatal ischemic stroke within 2 years after PCI(Within 2 years after PCI)
研究者
Chunfeng Dai
Principal Investigator
Shanghai Zhongshan Hospital