A Registration Study on Percutaneous Coronary Intervention for Patients With Myocardial Infarction at Fujian Provincial Hospital
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,344
- 主要终点
- The number of participants experiencing related adverse events after percutaneous coronary intervention
研究概览
简要总结
Research Objectives:
This clinical trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI). The primary objective is to determine whether this approach can reduce the incidence of major adverse cardiovascular events (MACE) compared to current conservative treatment.
Research Questions:
This study aims to address the following key questions:
Does standard PCI improve the clinical outcomes of MI patients (such as cardiovascular death, recurrent myocardial infarction, or revascularization due to ischemia-driven vascular reconstruction)? How safe is PCI, especially in terms of bleeding risk, surgical-related complications, or other adverse events? Does PCI have a significant impact on specific secondary endpoints (such as stent thrombosis, hospitalization for heart failure, or quality of life indicators)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Clinical diagnosis of acute myocardial infarction.
- •Successful direct or emergency PCI of the infarct-related artery.
- •Ability to undergo randomization post-PCI.
- •Ability to understand and voluntarily sign the informed consent form.
排除标准
- •PCI failure (final TIMI flow < grade 2) or presence of untreated severe stenosis.
- •Planned staged PCI or other cardiac surgery within 3 months.
- •Cardiogenic shock (Killip class IV), severe structural heart disease, or contraindications to PCI trial intervention.
- •Active bleeding or high bleeding risk.
- •Known allergy to the trial drug or its components.
- •ALT/AST > 3x upper limit of normal (ULN); eGFR < 30 mL/min/1.73 m².
- •Non-cardiovascular disease with life expectancy < 1 year (e.g., active malignancy).
- •History of hemorrhagic stroke, or any ischemic stroke/transient ischemic attack within the past 6 months.
- •Requirement for long-term oral anticoagulation therapy.
- •Pregnancy, lactation, or women of childbearing potential not using effective contraception.
- •Current participation in another interventional clinical trial.
- •Any condition that may affect trial compliance, safety assessment, or result interpretation per investigator judgment.
研究组 & 干预措施
Percutaneous Coronary Intervention (PCI)
The main indicators for evaluating the effectiveness and safety of the experimental intervention measures. Participants will receive the new or experimental treatment as stipulated in the trial protocol.
Intervention measures description: Standard percutaneous coronary intervention (PCI)
干预措施: Percutaneous Coronary Intervention (Procedure)
结局指标
主要结局
The number of participants experiencing related adverse events after percutaneous coronary intervention
时间窗: From the time of enrollment (baseline) to the 7-year follow-up after the surgery
Baseline data: Age, gender, height, weight, body mass index, systolic blood pressure at admission, diastolic blood pressure at admission, heart rate, smoking history, past medical history Hospital Admission Situation Perioperative period: The diseased blood vessels, number of stent implants, and biochemical indicators of this surgery; Primary outcome indicators: During hospitalization, the number of related adverse events that occurred in patients around the 7th day after surgery - hematoma at the puncture site, contrast-induced nephropathy, coronary artery dissection, stent thrombosis, etc. Hospitalization events: GRACE score, death during hospitalization Continuous follow-up until the last patient was enrolled (from June 2, 2017 to October 23, 2024): All-cause death, MACE1, stroke, recurrent myocardial infarction, stent restenosis, percutaneous coronary intervention, unplanned vascular reconstruction
次要结局
未报告次要终点
研究者
Kaiyang Lin
Chief Physician
Fujian Provincial Hospital