A Clinical Cohort Registry Study on Primary PCI for Acute Myocardial Infarction at Zhongshan Hospital
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 6,000
- 试验地点
- 2
- 主要终点
- Incidence of MACCE during hospitalization
研究概览
简要总结
This study is a registry-based cohort investigation, prospectively enrolling patients who were diagnosed with acute myocardial infarction and underwent primary percutaneous coronary intervention (PCI) at Zhongshan Hospital, Fudan University, between January 1, 2009, and December 31, 2028. Baseline clinical characteristics, procedural details, laboratory results, and medication records will be systematically collected and documented. The clinical follow-up will encompass both in-hospital monitoring and post-discharge surveillance extending up to two years after the procedure.
详细描述
This is a registered prospective study that consecutively enrolled patients who were diagnosed with acute myocardial infarction (AMI) and underwent primary percutaneous coronary intervention (PCI) at Zhongshan Hospital, Fudan University, from January 2009 to December 2028. The study recorded each patient's baseline demographics, clinical history, physical examination data, laboratory results, medication usage, and procedural details. The predefined clinical endpoints include both in-hospital and long-term follow-up events. The former encompasses major adverse cardiovascular and cerebrovascular events (MACCE) composed of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, malignant arrhythmias, acute heart failure, cardiogenic shock, and cerebrovascular accidents, as well as various bleeding events, gout flares, and intraoperative microcirculatory perfusion status during PCI. The latter includes MACCE composed of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, readmission for acute heart failure, and cerebrovascular accidents, as well as changes in cardiac function during long-term follow-up. The occurrence of malignant tumors was designated as a falsification endpoint to assess the potential impact of confounding factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elevated or decreasing levels of cardiac troponin T, with at least one measurement exceeding 0.014 ng/mL;
- •Presence of at least one of the following: symptoms of myocardial ischemia; newly onset ischemic changes on ECG; pathological Q wave; imaging evidence of new loss of viable myocardium or regional wall motion abnormalities consistent with ischemia; coronary angiography confirming the presence of a thrombus;
- •Undergoing primary PCI;
- •Voluntary informed consent to participate in the study.
排除标准
- •Inability to complete emergent PCI (e.g., due to intraoperative complications or inability to tolerate the procedure).
- •Prior administration of thrombolytic therapy before PCI.
- •Diagnosis of type 2 or type 3 myocardial infarction.
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
Incidence of MACCE during hospitalization
时间窗: Periprocedural
Major adverse cardiovascular and cerebrovascular events (MACCE) occurring during hospitalization, including all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, malignant arrhythmias, acute heart failure, cardiogenic shock, and cerebrovascular accidents
Incidence of MACCE during long-term follow-up
时间窗: 2 years after PCI
Major adverse cardiovascular and cerebrovascular events (MACCE) occurring during out-of-hospital follow-up, including all-cause death, recurrent acute myocardial infarction, ischemia-driven repeat revascularization, rehospitalization for acute heart failure, and cerebrovascular accident.
次要结局
- Incidence of bleeding events during hospitalization(Periprocedural)
- Incidence of gout flare during hospitalization(Periprocedural)
- Incidence of myocardial perfusion impairment during primary PCI(Periprocedural)
研究者
Chunfeng Dai
Principal Investigator
Shanghai Zhongshan Hospital