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

NCT07400601 | Recruiting DMC

• 1 other identifier: B2021-833
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction (AMI)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Incidence of bleeding events during hospitalization

  Periprocedural

• Incidence of gout flare during hospitalization

  Periprocedural

• Incidence of myocardial perfusion impairment during primary PCI

  Periprocedural

Other Outcomes (2)

• Cardiac function status during long-term follow-up

  up to 2 years

• The Incidence of Malignant Tumors

  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

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

All patients will have 5 ml of peripheral venous blood drawn for biochemical analysis before the 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: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)