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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Collection of baseline characteristics

    Other intervention

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

Treatment groups

6,000 Participants
are divided into 1 treatment group
Group A: AMI patients undergoing primary PCI1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Periprocedural
2

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.

Time frame
2 years after PCI

Secondary outcomes

1

Incidence of bleeding events during hospitalization

Various bleeding events during hospitalization

Time frame
Periprocedural
2

Incidence of gout flare during hospitalization

Gout flare during hospitalization

Time frame
Periprocedural
3

Incidence of myocardial perfusion impairment during primary PCI

TIMI \< 3

Time frame
Periprocedural

Other outcomes

1

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.

Time frame
up to 2 years
2

The Incidence of Malignant Tumors

The Incidence of Malignant Tumors During Long-Term Follow-Up

Time frame
2 years after PCI

Sponsors and contacts

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