Acute Myocardial Infarction, Heart Failure
Conditions
Keywords
Lung Ultrasound
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTLung ultrasound
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
Sponsors
Institut Hospital del Mar d'Investigacions Médiques
Hospital Vall d'Hebron
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined endpoint in a short follow-up: heart failure, acute coronary syndrome or death, | Up to 30 days since prior revascularization | Composite of readmission for acute HF or new ACS (hospitalization or \>24 hours of stay in the Emergency Department) or death from any cause. |
| Acute renal injury during hospitalization | During hospitalization due to prior STEMI, after revascularization and LUS performance. | Acute Kidney Injury Network (AKIN) criteria I, II or III or hemodialysis requirement |
| 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. | 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). |
| Ventilatory support during hospitalization | During hospitalization due to prior STEMI, after revascularization and LUS performance. | Need of ventilatory support (invasive or non-invasive mechanical ventilation) during hospitalization. |
| Development of arrhythmias during follow-up | Up to 12 months | New-onset atrial fibrillation, atrial flutter, sustained ventricular tachycardia or ventricular fibrillation during hospitalization and during follow-up. |
| Development of atrial fibrilation/flutter during hospitalization | During hospitalization due to prior STEMI, after revascularization and LUS performance. | New-onset atrial fibrillation or atrial flutter during hospitalization in patients without prior history of these arrhythmias. |
Countries
Spain
Outcome results
None listed