NCT07400601

A Clinical Cohort Registry Study on Primary PCI for Acute Myocardial Infarction at Zhongshan Hospital

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a registry-based cohort investigation, prospectively enrolling patients who were diagnosed with acute myocardial infarction and underwent primary percutaneous coronary intervention (PCI) at Zhongshan Hospital, Fudan University, between January 1, 2009, and December 31, 2028. Baseline clinical characteristics, procedural details, laboratory results, and medication records will be systematically collected and documented. The clinical follow-up will encompass both in-hospital monitoring and post-discharge surveillance extending up to two years after the procedure.

Detailed description

This is a registered prospective study that consecutively enrolled patients who were diagnosed with acute myocardial infarction (AMI) and underwent primary percutaneous coronary intervention (PCI) at Zhongshan Hospital, Fudan University, from January 2009 to December 2028. The study recorded each patient's baseline demographics, clinical history, physical examination data, laboratory results, medication usage, and procedural details. The predefined clinical endpoints include both in-hospital and long-term follow-up events. The former encompasses major adverse cardiovascular and cerebrovascular events (MACCE) composed of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, malignant arrhythmias, acute heart failure, cardiogenic shock, and cerebrovascular accidents, as well as various bleeding events, gout flares, and intraoperative microcirculatory perfusion status during PCI. The latter includes MACCE composed of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, readmission for acute heart failure, and cerebrovascular accidents, as well as changes in cardiac function during long-term follow-up. The occurrence of malignant tumors was designated as a falsification endpoint to assess the potential impact of confounding factors.

Conditions

• Acute Myocardial Infarction (AMI)

Interventions

Type	Name	Description
OTHER	Collection of baseline characteristics	Collection of baseline clinical characteristics, procedural details, laboratory results, and medication records

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2026-02-10
• Last updated: 2026-02-11

Locations

1 site across 1 country: China