The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.
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.
Study Type
OBSERVATIONAL
Enrollment
400
Lung ultrasound performed with a portable device with an 8 zones protocol within the first 24 hours after and ST-segment elevation acute myocardial infarction
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause.
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.
Time frame: Up to 12 months since revascularization and LUS performance.
Combined endpoint during hospitalization: death or acute heart failure (congestive HF or cardiogenic shock) in STEMI Killip I patients.
Acute congestive heart failure, defined as the presence of three conditions: 1) dyspnea at rest; 2) peripheral oxygen saturation (SpO2) \<90% or need for oxygen to maintain adequate SpO2; and 3) presence of crackles or elevated natriuretic peptides (NTproBNP \>450 pg/ml \<50 years-old, \>900 50-75y, \>1800 \>75 years-old). Cardiogenic shock was defined according to current guidelines as systolic blood pressure \<90 mm Hg for at least 30 minutes or the need for supportive measures to maintain systolic blood pressure ≥90 mm Hg) despite adequate filling status with clinical and laboratory evidence of end-organ hypoperfusion. This outcome will be analyzed only in patients without signs of HF at admission (Killip I).
Time frame: 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,
Composite of readmission for acute HF or new ACS (hospitalization or \>24 hours of stay in the Emergency Department) or death from any cause.
Time frame: Up to 30 days since prior revascularization
Acute renal injury during hospitalization
Acute Kidney Injury Network (AKIN) criteria I, II or III or hemodialysis requirement
Time frame: During hospitalization due to prior STEMI, after revascularization and LUS performance.
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Development of atrial fibrilation/flutter during hospitalization
New-onset atrial fibrillation or atrial flutter during hospitalization in patients without prior history of these arrhythmias.
Time frame: During hospitalization due to prior STEMI, after revascularization and LUS performance.
Ventilatory support during hospitalization
Need of ventilatory support (invasive or non-invasive mechanical ventilation) during hospitalization.
Time frame: During hospitalization due to prior STEMI, after revascularization and LUS performance.
Development of arrhythmias during follow-up
New-onset atrial fibrillation, atrial flutter, sustained ventricular tachycardia or ventricular fibrillation during hospitalization and during follow-up.
Time frame: Up to 12 months