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NCT Number: NCT07400601

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Zhongshan Hospital

Shanghai, China

Location status: Recruiting

Location contact

Chunfeng Dai, M.D.

CONTACT

[email protected]

86-021-64041990

Chunfeng Dai, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of baseline characteristics

Other

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

Primary outcomes

  1. Incidence of MACCE during hospitalization

    Time frame: Periprocedural

    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

  2. Incidence of MACCE during long-term follow-up

    Time frame: 2 years after PCI

    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.

Secondary outcomes

  1. Incidence of bleeding events during hospitalization

    Time frame: Periprocedural

    Various bleeding events during hospitalization

  2. Incidence of gout flare during hospitalization

    Time frame: Periprocedural

    Gout flare during hospitalization

  3. Incidence of myocardial perfusion impairment during primary PCI

    Time frame: Periprocedural

    TIMI < 3

Other outcomes

  1. Cardiac function status during long-term follow-up

    Time frame: up to 2 years

    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.

  2. The Incidence of Malignant Tumors

    Time frame: 2 years after PCI

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chunfeng Dai, M.D.

CONTACT

[email protected]

86-021-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Acronym: ZSPPCI

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 10, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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