Trends and Risk Factors of Adverse Cardiovascular and Cerebrovascular Events After Primary PCI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Collection of baseline characteristics
Other interventionCollection of baseline clinical characteristics, procedural details, laboratory results, and medication records
Treatment groups
8,000 Participants
are divided into 1 treatment groupGroup A: AMI patients undergoing primary PCI1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 2 years after PCISecondary outcomes
1
In-hospital all-cause death
Death from any cause during hospitalization.
Time frame
Perioperative/Periprocedural2
In-hospital impaired myocardial perfusion
Post-PCI TIMI flow grade \<3 in the infarct-related artery.
Time frame
At the end of the PCI procedure3
In-hospital malignant arrhythmia
New-onset ventricular tachycardia, ventricular fibrillation, or other malignant arrhythmias requiring drug therapy, electrical cardioversion/defibrillation, or temporary pacing during hospitalization.
Time frame
Perioperative/Periprocedural4
In-hospital acute heart failure
New-onset or worsening acute heart failure requiring intravenous diuretics, vasoactive drugs, or mechanical support (e.g., IABP, ECMO).
Time frame
Perioperative/PeriproceduralOther outcomes
1
Bleeding events
Bleeding events defined by the Bleeding Academic Research Consortium (BARC) within 2 years after PCI.
Time frame
Within 2 years after PCI2
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 \<50% indicates impaired left ventricular systolic function.
Time frame
Up to 2 years after PCI3
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.
Time frame
Within 2 years after PCISponsors and contacts
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Source ClinicalTrials.gov