Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction-- Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Occurrence of heart failure
研究概览
简要总结
Reperfusion therapy for acute ST segment elevation myocardial infarction (STEMI) can significantly reduce mortality, but patients may still have heart failure and adverse cardiovascular events due to massive myocardial loss. About 20% of patients present with acute heart failure (AHF) at admission, It is the most important cause of hospital death in acute myocardial infarction. Because of the large necrotic area of acute anterior myocardial infarction, heart failure still occurs in a considerable number of patients even after revascularization (PCI). Myocardial protection of ischemic myocardium is a hot topic in clinical research.
Both ESC and Chinese heart failure guidelines recommend levosimendan for the treatment of acute decompensated heart failure. A large number of studies have proved that levosimendan can significantly reduce myocardial injury and improve cardiac function in patients with acute STEMI complicated with left ventricular dysfunction and cardiogenic shock compared with placebo. Basic research has confirmed that levosimendan can reduce the myocardial infarction area after acute coronary occlusion, improve the left ventricular function, and exert the effects of anti myocardial ischemia, myocardial injury, myocardial fibrosis, ventricular remodeling and anti apoptosis. However, there is still a lack of early preventive application of levosimendan in acute anterior myocardial infarction after PCI to improve ventricular remodeling and reduce the incidence of heart failure.
The purpose of this study was to investigate the effect of early prophylactic levosimendan on left ventricular remodeling, ischemic myocardial protection and the development of heart failure in patients with acute anterior myocardial infarction after PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Acute anterior wall myocardial infarction (ECG indicates acute anterior wall, acute anterior wall myocardial infarction, acute extensive anterior wall myocardial infarction).
- •The onset time of chest pain was less than 12 hours, and agreed to emergency PCI treatment.
- •Be able to understand and sign informed consent voluntarily.
排除标准
- •Patients who cannot undergo PCI treatment after coronary angiography, or those who fail to open blood vessels, or refuse to undergo PCI treatment.
- •Those whose coronary angiography results indicated myocardial infarction caused by non-coronary artery disease or residual stenosis < 50% after reanalization of myocardial infarction without PCI treatment.
- •Patients with old anterior wall myocardial infarction.
- •Previous history of cardiac insufficiency.
- •Both anterior descending stent implantation, stent restenosis or stent thrombosis.
- •Symptomatic hypotension, systolic blood pressure < 90mmHg (still < 90mmHg with IABP)
- •7, body temperature > 38.5℃, or with serious infectious diseases (severe myocarditis, severe pneumonia, severe urinary tract infection, etc.).
- •Severe other organ diseases (renal insufficiency: EGFR < 30ml/min, severe liver insufficiency, moderate and severe anemia, malignant tumor, hematologic system diseases, etc.).
- •Known or suspected allergy to the active or inactive ingredients of the drug under study.
- •Participated in other drug clinical trials within 3 months before the trial.
研究组 & 干预措施
Levosimendan group
干预措施: Levosimendan (Drug)
placebo group
干预措施: placebo (Other)
结局指标
主要结局
Occurrence of heart failure
时间窗: 6 month
6 month of heart failure
Major Adverse Cardiovascular Events (MACE)
时间窗: 6 months
Mace is defined as cardiovascular death and cardiovascular related readmission
Left ventricular systolic function
时间窗: 72 hours
At 72 hours, left ventricular systolic function of AFI is as follows ( PSD, GLS, PSI)
次要结局
- NT-ProBNP(30 days)
- Patient quality of life score(30 days)
研究者
Zhijun Sun
Director of the second Department of cardiovascular medicine
Shengjing Hospital