Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause.
Time Frame: 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 Outcomes
- 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)