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

Heart Failure Clinical Trial

— LUS-AMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526535
• Other study ID #: IIBSP-ECO-2019-105
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Hospital Vall d'Hebron, Institut Hospital del Mar d'Investigacions Médiques

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Araujo GN, Silveira AD, Scolari FL, Custodio JL, Marques FP, Beltrame R, Menegazzo W, Machado GP, Fuchs FC, Goncalves SC, Wainstein RV, Leiria TL, Wainstein MV. Admission Bedside Lung Ultrasound Reclassifies Mortality Prediction in Patients With ST-Segmen — View Citation

Araujo GND, Marques F, Scolari F, et al. Comparison of Lung Ultrasound and Killip Classification in Patients with St-Segment Elevation Myocardial Infarction Submitted to Coronary Angiography. J Am Coll Cardiol 2019;73:182.

Coiro S, Rossignol P, Ambrosio G, Carluccio E, Alunni G, Murrone A, Tritto I, Zannad F, Girerd N. Prognostic value of residual pulmonary congestion at discharge assessed by lung ultrasound imaging in heart failure. Eur J Heart Fail. 2015 Nov;17(11):1172-8 — View Citation

Farré N, Fort A, Tizón-Marcos H, et al. Epidemiology of heart failure in myocardial infarction treated with primary angioplasty: Analysis of the Codi IAM registry. REC: CardioClinics 2019;54:41-49.

Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patient — View Citation

Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10. — View Citation

Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313. — View Citation

Pivetta E, Goffi A, Lupia E, Tizzani M, Porrino G, Ferreri E, Volpicelli G, Balzaretti P, Banderali A, Iacobucci A, Locatelli S, Casoli G, Stone MB, Maule MM, Baldi I, Merletti F, Cibinel GA, Baron P, Battista S, Buonafede G, Busso V, Conterno A, Del Rizz — View Citation

Platz E, Jhund PS, Girerd N, Pivetta E, McMurray JJV, Peacock WF, Masip J, Martin-Sanchez FJ, Miro O, Price S, Cullen L, Maisel AS, Vrints C, Cowie MR, DiSomma S, Bueno H, Mebazaa A, Gualandro DM, Tavares M, Metra M, Coats AJS, Ruschitzka F, Seferovic PM, — View Citation

Platz E, Lewis EF, Uno H, Peck J, Pivetta E, Merz AA, Hempel D, Wilson C, Frasure SE, Jhund PS, Cheng S, Solomon SD. Detection and prognostic value of pulmonary congestion by lung ultrasound in ambulatory heart failure patients. Eur Heart J. 2016 Apr 14;3 — View Citation

Rivas-Lasarte M, Alvarez-Garcia J, Fernandez-Martinez J, Maestro A, Lopez-Lopez L, Sole-Gonzalez E, Pirla MJ, Mesado N, Mirabet S, Fluvia P, Brossa V, Sionis A, Roig E, Cinca J. Lung ultrasound-guided treatment in ambulatory patients with heart failure: a — View Citation

Ye XJ, Li N, Li JH, Wu WJ, Li AL, Li XL. B-lines by lung ultrasound predict heart failure in hospitalized patients with acute anterior wall STEMI. Echocardiography. 2019 Jul;36(7):1253-1262. doi: 10.1111/echo.14420. Epub 2019 Jul 9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary combined outcome: incidence of any cause mortality or hospitalization secondary to cardiovascular cause.	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	Combined endpoint during hospitalization: death or acute heart failure (congestive HF or cardiogenic shock) in STEMI Killip I patients.	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.
Secondary	Combined endpoint in a short follow-up: heart failure, acute coronary syndrome or death,	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
Secondary	Acute renal injury during hospitalization	Acute Kidney Injury Network (AKIN) criteria I, II or III or hemodialysis requirement	During hospitalization due to prior STEMI, after revascularization and LUS performance.
Secondary	Development of atrial fibrilation/flutter during hospitalization	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.
Secondary	Ventilatory support during hospitalization	Need of ventilatory support (invasive or non-invasive mechanical ventilation) during hospitalization.	During hospitalization due to prior STEMI, after revascularization and LUS performance.
Secondary	Development of arrhythmias during follow-up	New-onset atrial fibrillation, atrial flutter, sustained ventricular tachycardia or ventricular fibrillation during hospitalization and during follow-up.	Up to 12 months