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

NCT07833995 | Recruiting DMC

• 1 other identifier: B2026-593
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction (AMI); Percutaneous Coronary Intervention (PCI)

Outcome Measures

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.

  Within 2 years after PCI

Secondary Outcomes (11)

• In-hospital all-cause death

  Perioperative/Periprocedural

• In-hospital impaired myocardial perfusion

  At the end of the PCI procedure

• In-hospital malignant arrhythmia

  Perioperative/Periprocedural

• In-hospital acute heart failure

  Perioperative/Periprocedural

• In-hospital recurrent myocardial infarction

  Perioperative/Periprocedural

Other Outcomes (3)

• Bleeding events

  Within 2 years after PCI

• Cardiac function status during long-term follow-up

  Up to 2 years after PCI

• Malignancy as a Negative Control Outcome

  Within 2 years after PCI

Study Arms (1)

AMI patients undergoing primary PCI

Acute myocardial infarction patients undergoing primary PCI

Other: Collection of baseline characteristics

Interventions

Collection of baseline characteristics OTHER

Collection of baseline clinical characteristics, procedural details, laboratory results, and medication records

AMI patients undergoing primary PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

All patients will have 5 mL of peripheral venous blood drawn for biochemical analysis before primary PCI and again on the first day after the procedure.

Study Officials

• Chunfeng Dai, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunfeng Dai, M.D.

CONTACT

86-021-64041990; dai.chunfeng@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): March 31, 2031
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)