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
- Acute Myocardial Infarction (AMI)
- Percutaneous Coronary Intervention (PCI)
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Shanghai Zhongshan Hospital
- Enrolment target
- 8,000
- Started
- 28 September 2026
- Main results due
- 31 December 2030
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Zhongshan Hospital, Fudan University
Shanghai, China
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07833995. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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