Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)

Study Overview
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Brief Summary
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The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.

Detailed Description
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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.

Official Title
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Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)

Conditions
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Acute Myocardial Infarction, Heart Failure

Intervention / Treatment
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* Diagnostic Test: Lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (more than 18 years) admitted with confirmed ST-segment elevation acute myocardial infarction (STEMI). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No B-lines<br>Patients with no significant B lines in the lung ultrasound at first 24 hours after acute myocardial infarction (any field with 3 or more B-lines) | Diagnostic Test: Lung ultrasound<br>* 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<br>|
| B lines<br>Patients with significant B lines in the lung ultrasound at first 24 hours after acute myocardial infarction (3 or more B-lines in at least one lung field) | Diagnostic Test: Lung ultrasound<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months since revascularization and LUS performance. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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 | During hospitalization due to prior STEMI, after revascularization and LUS performance. | 
| Development of atrial fibrilation/flutter during hospitalization | New-onset atrial fibrillation or atrial flutter during hospitalization in patients without prior history of these arrhythmias. | 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. | 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. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Ultrasound