Clinical trial NCT04526535: Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)
Official title: Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Heart Failure
Keywords: Lung Ultrasound
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Institut Hospital del Mar d'Investigacions Médiques
name: Hospital Vall d'Hebron
First posted: 2020-08-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults admitted with STEMI during 1 year in three terciary centers who meet inclusion criteria.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause.
timeFrame: Up to 12 months since revascularization and LUS performance.
Secondary outcomes:
measure: Combined endpoint during hospitalization: death or acute heart failure (congestive HF or cardiogenic shock) in STEMI Killip I patients.
timeFrame: During hospitalization due to prior STEMI, after revascularization and LUS performance.
measure: Combined endpoint in a short follow-up: heart failure, acute coronary syndrome or death,
timeFrame: Up to 30 days since prior revascularization
measure: Acute renal injury during hospitalization
timeFrame: During hospitalization due to prior STEMI, after revascularization and LUS performance.
measure: Development of atrial fibrilation/flutter during hospitalization
timeFrame: During hospitalization due to prior STEMI, after revascularization and LUS performance.
measure: Ventilatory support during hospitalization
timeFrame: During hospitalization due to prior STEMI, after revascularization and LUS performance.
measure: Development of arrhythmias during follow-up
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Jose Carreras-Mora, MD.
role: PRINCIPAL_INVESTIGATOR
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