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NCT Number: NCT04526535

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

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

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Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Ultrasound

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Combined endpoint during hospitalization: death or acute heart failure (congestive HF or cardiogenic shock) in STEMI Killip I patients.

    Time frame: 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).

  2. Combined endpoint in a short follow-up: heart failure, acute coronary syndrome or death,

    Time frame: 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.

  3. Acute renal injury during hospitalization

    Time frame: During hospitalization due to prior STEMI, after revascularization and LUS performance.

    Acute Kidney Injury Network (AKIN) criteria I, II or III or hemodialysis requirement

  4. Development of atrial fibrilation/flutter during hospitalization

    Time frame: 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.

  5. Ventilatory support during hospitalization

    Time frame: During hospitalization due to prior STEMI, after revascularization and LUS performance.

    Need of ventilatory support (invasive or non-invasive mechanical ventilation) during hospitalization.

  6. Development of arrhythmias during follow-up

    Time frame: Up to 12 months

    New-onset atrial fibrillation, atrial flutter, sustained ventricular tachycardia or ventricular fibrillation during hospitalization and during follow-up.

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Hospital Vall d'Hebron
  • Institut Hospital del Mar d'Investigacions Médiques

Registry information

Acronym: LUS-AMI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2020
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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