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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction (AMI)
• Intervention / Treatment: Other: Collection of baseline characteristics

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.

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Chunfeng Dai, M.D.; Phone Number: 86-021-64041990; Email: dai.chunfeng@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Zhongshan Hospital
    • Contact: Chunfeng Dai, M.D.; Phone Number: 86-021-64041990; Email: dai.chunfeng@zs-hospital.sh.cn
    • Principal Investigator: Chunfeng Dai, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Elevated or decreasing levels of cardiac troponin T, with at least one measurement exceeding 0.014 ng/mL;
• Presence of at least one of the following: symptoms of myocardial ischemia; newly onset ischemic changes on ECG; pathological Q wave; imaging evidence of new loss of viable myocardium or regional wall motion abnormalities consistent with ischemia; coronary angiography confirming the presence of a thrombus;
• Undergoing primary PCI;
• Voluntary informed consent to participate in the study.

Exclusion Criteria:

• Inability to complete emergent PCI (e.g., due to intraoperative complications or inability to tolerate the procedure).
• Prior administration of thrombolytic therapy before PCI.
• Diagnosis of type 2 or type 3 myocardial infarction.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AMI patients undergoing primary PCI; Acute myocardial infarction patients undergoing primary PCI	Other: Collection of baseline characteristics; Collection of baseline clinical characteristics, procedural details, laboratory results, and medication records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MACCE during hospitalization	Major adverse cardiovascular and cerebrovascular events (MACCE) occurring during hospitalization, including all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, malignant arrhythmias, acute heart failure, cardiogenic shock, and cerebrovascular accidents	Periprocedural
Incidence of MACCE during long-term follow-up	Major adverse cardiovascular and cerebrovascular events (MACCE) occurring during out-of-hospital follow-up, including all-cause death, recurrent acute myocardial infarction, ischemia-driven repeat revascularization, rehospitalization for acute heart failure, and cerebrovascular accident.	2 years after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bleeding events during hospitalization	Various bleeding events during hospitalization	Periprocedural
Incidence of gout flare during hospitalization	Gout flare during hospitalization	Periprocedural
Incidence of myocardial perfusion impairment during primary PCI	TIMI < 3	Periprocedural

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac function status during long-term follow-up	Document the changes in left ventricular ejection fraction (LVEF) during long-term follow-up. A normal LVEF is over 53%, while an LVEF <50% indicates impaired cardiac systolic function.	up to 2 years
The Incidence of Malignant Tumors	The Incidence of Malignant Tumors During Long-Term Follow-Up	2 years after PCI

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Chunfeng Dai, M.D., Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: B2021-833

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research involves some confidential content

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No