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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMI patients undergoing primary PCI | Acute myocardial infarction patients undergoing primary PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of baseline characteristics | Other | Collection of baseline clinical characteristics, procedural details, laboratory results, and medication records |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MACCE during hospitalization | 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 | Periprocedural |
| Incidence of MACCE during long-term follow-up | 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. | 2 years after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bleeding events during hospitalization | Various bleeding events during hospitalization | Periprocedural |
| Incidence of gout flare during hospitalization | Gout flare during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac function status during long-term follow-up | Document the changes in left ventricular ejection fraction (LVEF) during long-term follow-up. A normal LVEF is over 53%, while an LVEF <50% indicates impaired cardiac systolic function. | up to 2 years |
| The Incidence of Malignant Tumors |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunfeng Dai, M.D. | Contact | 86-021-64041990 | dai.chunfeng@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chunfeng Dai, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | China |
The research involves some confidential content
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All patients will have 5 ml of peripheral venous blood drawn for biochemical analysis before the primary PCI and again on the first day after the procedure.
| Periprocedural |
| Incidence of myocardial perfusion impairment during primary PCI | TIMI < 3 | Periprocedural |
The Incidence of Malignant Tumors During Long-Term Follow-Up |
| 2 years after PCI |