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

February 28, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults admitted with STEMI during 1 year in three terciary centers who meet inclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No B-lines
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
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
B lines
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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).
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,
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.
Up to 30 days since prior revascularization
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
During hospitalization due to prior STEMI, after revascularization and LUS performance.
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.
During hospitalization due to prior STEMI, after revascularization and LUS performance.
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.
During hospitalization due to prior STEMI, after revascularization and LUS performance.
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ECO-2019-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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