Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause.
研究概览
简要总结
The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.
详细描述
LUS-AMI is an observational cohort prospective study that evaluates the prognostic value of lung ultrasound, specifically the number of B-lines, performed within the first 24 hours after and ST-segment elevation acute myocardial infarction, by an independent operator blinded to clinical outcomes and off-line analysis by another independent operator also blinded to clinical outcomes.
The primary outcome during hospitalization was a composite of clinically significant acute HF, cardiogenic shock, or death from any cause after LUS was performed. New-onset atrial fibrillation, acute renal injury (Acute Kidney Injury Network ≥ 1), and need for ventilatory support (invasive or non-invasive) during hospitalization were also analyzed as secondary outcomes.
The primary outcome during follow-up is one year after STEMI is a composite of any cause mortality, hospitalization secondary to cardiovascular disease (aborted sudden cardiac arrest, acute coronary syndrome, heart failure or stroke) or need for urgent coronary revascularization.
Secondary outcomes are new onset heart failure during hospitalization, acute kidney injury during hospitalization, new-onset atrial fibrillation/flutter during hospitalization, need of ventilatory support during hospitalization and new-onset clinically relevant arrhythmia (atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) during follow-up. A short-term follow-uo (30 days after prior PCI) will be also performed to analyze a combined endpoint of death from any cause or hospitalization due to acute HF or new acute coronary syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults (more than 18 years) admitted with confirmed ST-segment elevation acute myocardial infarction (STEMI).
排除标准
- •Absence of coronary artery disease and myocardial injury (false positive)
- •Non interpretable lung ultrasound
- •Severe lung disease (fibrosis, severe COPD, pleural disease, lobectomy or pneumonectomy)
- •Acute respiratory distress syndrome
- •Pneumonia or SDRA at admission or during hospitalization
- •Follow-up inability
- •Hemodialysis therapy previous to admission
- •Life expectancy less than 6 months secondary to extracardiac pathology.
结局指标
主要结局
Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause.
时间窗: Up to 12 months since revascularization and LUS performance.
Combined outcome of: mortality from any cause, readmission due to cardiovascular cause (aborted sudden cardiac arrest, acute coronary syndrome, heart failure or stroke) or the need for urgent coronary revascularization at a 12-month follow-up since prior revascularization.
次要结局
- Combined endpoint during hospitalization: death or acute heart failure (congestive HF or cardiogenic shock) in STEMI Killip I patients.(During hospitalization due to prior STEMI, after revascularization and LUS performance.)
- Combined endpoint in a short follow-up: heart failure, acute coronary syndrome or death,(Up to 30 days since prior revascularization)
- Acute renal injury during hospitalization(During hospitalization due to prior STEMI, after revascularization and LUS performance.)
- Development of atrial fibrilation/flutter during hospitalization(During hospitalization due to prior STEMI, after revascularization and LUS performance.)
- Ventilatory support during hospitalization(During hospitalization due to prior STEMI, after revascularization and LUS performance.)
- Development of arrhythmias during follow-up(Up to 12 months)