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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07400601
Acronym
ZSPPCI
Enrollment
0
Registered
2026-02-10
Start date
2026-02-01
Completion date
2030-12-31
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction (AMI)

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.

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.

Interventions

OTHERCollection of baseline characteristics

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

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of MACCE during hospitalizationPeriproceduralMajor 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
Incidence of MACCE during long-term follow-up2 years after PCIMajor 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.

Secondary

MeasureTime frameDescription
Incidence of bleeding events during hospitalizationPeriproceduralVarious bleeding events during hospitalization
Incidence of gout flare during hospitalizationPeriproceduralGout flare during hospitalization
Incidence of myocardial perfusion impairment during primary PCIPeriproceduralTIMI \< 3

Countries

China

Contacts

PRINCIPAL_INVESTIGATORChunfeng Dai, M.D.

Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026