Trends and risk factors for adverse events after primary PCI in AMI patients over 20 years
Official title: 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
Run by Shanghai Zhongshan Hospital · NCT07833995 · Data updated 2026-11-12
This study looks at real-world AMI patients who had a primary PCI to see how often serious events happen during a 2-year follow-up and what factors predict them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 8000 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | September 28, 2026 |
| Main results expected | December 31, 2030 |
| Study ends | March 31, 2031 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07833995 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with AMI who underwent primary PCI at Zhongshan Hospital between 2009 and 2028 and who provide consent or have a waiver.
✕Probably not a fit
Patients not undergoing PCI, or with missing key data, or loss to follow-up may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center ambispective cohort study using real-world data from Zhongshan Hospital, Fudan University, including about 8,000 adults with AMI treated with primary PCI from 2009 to 2028. Participants are grouped into four time periods to describe long-term in-hospital and 2-year MACCE rates. The primary outcome is 2-year MACCE, a composite of death, recurrent MI, ischemia-driven repeat revascularization, and non-fatal stroke; secondary outcomes include in-hospital death and other events such as heart failure, arrhythmias, and bleeding. Data are drawn from electronic medical records and the cardiac catheterization database, with retrospective data collection through 2026 and prospective enrollment in 2027-2028. Analyses aim to describe incidence, trend over two decades, and identify independent risk factors for adverse outcomes.
Why it matters
Potential benefit: If successful, this study could illuminate long-term risks after primary PCI and help tailor follow-up and preventive strategies for AMI patients.
How similar studies have gone: Previous real-world analyses have demonstrated meaningful insights from long-term post-PCI data, supporting the potential value of this ambispective approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Zhongshan Hospital, Fudan University
Shanghai, China Recruiting
Study contacts
- Principal investigator: Chunfeng Dai, M.D. — Fudan University
- Study coordinator: Chunfeng Dai, M.D.
- Email: dai.chunfeng@zs-hospital.sh.cn
- Phone: 86-021-64041990
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.