[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657014":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":63,"studyPopulation":64,"armGroups":65,"interventions":71,"overallOfficials":76,"centralContacts":81,"locations":86,"responsibleParty":101,"collaborators":61,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":61,"enrollmentInfo":114,"targetDuration":117,"studyType":118,"phases":61,"briefSummary":119,"conditions":120,"keywords":61,"overallStatus":89,"whyStopped":61,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)","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.","Within 2 years after PCI",[14,18,22,25,28,31,34,37,40,43,46],{"measure":15,"description":16,"timeFrame":17},"In-hospital all-cause death","Death from any cause during hospitalization.","Perioperative\u002FPeriprocedural",{"measure":19,"description":20,"timeFrame":21},"In-hospital impaired myocardial perfusion","Post-PCI TIMI flow grade \\\u003C3 in the infarct-related artery.","At the end of the PCI procedure",{"measure":23,"description":24,"timeFrame":17},"In-hospital malignant arrhythmia","New-onset ventricular tachycardia, ventricular fibrillation, or other malignant arrhythmias requiring drug therapy, electrical cardioversion\u002Fdefibrillation, or temporary pacing during hospitalization.",{"measure":26,"description":27,"timeFrame":17},"In-hospital acute heart failure","New-onset or worsening acute heart failure requiring intravenous diuretics, vasoactive drugs, or mechanical support (e.g., IABP, ECMO).",{"measure":29,"description":30,"timeFrame":17},"In-hospital recurrent myocardial infarction","Recurrent myocardial infarction during hospitalization.",{"measure":32,"description":33,"timeFrame":17},"In-hospital non-fatal ischemic stroke","Non-fatal ischemic stroke during hospitalization.",{"measure":35,"description":36,"timeFrame":12},"All-cause death within 2 years after PCI","Death from any cause within 2 years after PCI.",{"measure":38,"description":39,"timeFrame":12},"Cardiovascular death within 2 years after PCI","Death from cardiovascular causes within 2 years after PCI. Cardiovascular death includes death due to myocardial infarction, heart failure, arrhythmia, stroke, or other cardiovascular causes.",{"measure":41,"description":42,"timeFrame":12},"Recurrent myocardial infarction within 2 years after PCI","Recurrent myocardial infarction within 2 years after PCI.",{"measure":44,"description":45,"timeFrame":12},"Ischemia-driven repeat revascularization within 2 years after PCI","Repeat PCI or CABG driven by ischemia within 2 years after the index PCI.",{"measure":47,"description":48,"timeFrame":12},"Non-fatal ischemic stroke within 2 years after PCI","Non-fatal ischemic stroke within 2 years after PCI.",[50,53,57],{"measure":51,"description":52,"timeFrame":12},"Bleeding events","Bleeding events defined by the Bleeding Academic Research Consortium (BARC) within 2 years after PCI.",{"measure":54,"description":55,"timeFrame":56},"Cardiac function status during long-term follow-up","To document changes in left ventricular ejection fraction (LVEF) during long-term follow-up. A normal LVEF is defined as \\>53%, while an LVEF \\\u003C50% indicates impaired left ventricular systolic function.","Up to 2 years after PCI",{"measure":58,"description":59,"timeFrame":12},"Malignancy as a Negative Control Outcome","Incident malignancy or malignancy-related death within 2 years after PCI, used as a negative control outcome to assess potential detection bias, surveillance bias, or residual confounding.",{"allocation":61,"interventionModel":61,"interventionModelDescription":61,"primaryPurpose":61,"observationalModel":62,"timePerspective":6,"maskingInfo":61},null,"COHORT","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.\n\nDesign: 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.\n\nObjectives: To describe the incidence and 20-year trends of in-hospital events and 2-year MACCE, and to identify independent risk factors.\n\nOutcomes: 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.\n\nData 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.\n\nEthics: Ethical approval will be obtained from the Ethics Committee of Zhongshan Hospital, Fudan University. Written informed consent will be obtained from prospective patients; verbal consent or a waiver will be requested for retrospective patients. No study-specific interventions are involved in this observational study.","This study is an ambispective, registry-based cohort study that includes patients diagnosed with acute myocardial infarction who underwent primary percutaneous coronary intervention (PCI) at Zhongshan Hospital, Fudan University, from January 1, 2009, to December 31, 2028.",[66],{"label":67,"type":61,"description":68,"interventionNames":69},"AMI patients undergoing primary PCI","Acute myocardial infarction patients undergoing primary PCI",[70],"Other: Collection of baseline characteristics",[72],{"type":6,"name":73,"description":74,"armGroupLabels":75,"otherNames":61},"Collection of baseline characteristics","Collection of baseline clinical characteristics, procedural details, laboratory results, and medication records",[67],[77],{"name":78,"affiliation":79,"role":80},"Chunfeng Dai, M.D.","Fudan University","PRINCIPAL_INVESTIGATOR",[82],{"name":78,"role":83,"phone":84,"phoneExt":61,"email":85},"CONTACT","86-021-64041990","dai.chunfeng@zs-hospital.sh.cn",[87],{"facility":88,"status":89,"city":90,"state":61,"zip":61,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","China","CN",{"type":94,"coordinates":95},"Point",[96,97],121.45806,31.22222,{"lat":97,"lon":96},[100],{"name":78,"role":83,"phone":84,"phoneExt":61,"email":85},{"type":80,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"Chunfeng Dai","Principal Investigator","100657014","trends-and-risk-factors-of-adverse-cardiovascular-and-cerebrovascular-events-after-primary-pci-100657014",false,"NCT07833995","Trends and Risk Factors of Adverse Cardiovascular and Cerebrovascular Events After Primary PCI","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","TRACE-pPCI","Inclusion Criteria:\n\n* 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, 2028.\n* Underwent primary percutaneous coronary intervention (PCI) during hospitalization (within 12 hours of symptom onset, or beyond 12 hours with persistent evidence of ischemia).\n* Aged 18 years or older at the time of PCI.\n* Informed consent obtained, or criteria for waiver of informed consent.\n\nExclusion Criteria:\n\n* Inability to tolerate PCI, or unsuccessful PCI.\n* Concomitant malignancy with an expected survival of less than 1 year.\n* Pregnant or breastfeeding women.\n* Missing data for key variables exceeding 30%, which would prevent valid analysis.\n* Any other condition that, in the investigator's opinion, precludes participation.","ALL","18 Years",{"count":115,"type":116},8000,"ESTIMATED","2 Years","OBSERVATIONAL","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.",[121,122],"Acute Myocardial Infarction (AMI)","Percutaneous Coronary Intervention (PCI)","2026-09-28",{"date":125,"type":126},"2026-09-29","ACTUAL",{"date":123,"type":126},{"date":129,"type":116},"2031-03-31",{"name":5,"class":6},1]