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Recruiting NCT07833995

Trends and Risk Factors of Adverse Cardiovascular and Cerebrovascular Events After Primary PCI

Conditions: Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 8000
Sponsor: Shanghai Zhongshan Hospital

Location: Zhongshan Hospital, Fudan University Shanghai

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07833995). StuddyBuddy aggregates publicly available trial information.