Acute Myocardial InfarctionLUS-AMINCT04526535
Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)
An observational study of Acute Myocardial Infarction and Heart Failure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure
- What is being tested?
- Lung ultrasound
- How many people
- 400 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Jun 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults admitted with STEMI during 1 year in three terciary centers who meet inclusion criteria.
Who may be able to join
- Adults (more than 18 years) admitted with confirmed ST-segment elevation acute myocardial infarction (STEMI).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital del Mar
Barcelona
About this study
The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.
Read the 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.
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Being tested
- Lung ultrasound
- Keywords
- Lung Ultrasound
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Lung ultrasound | |
| 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) Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months since revascularization and LUS performance.
Secondary outcomes (6)
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).
Measured: 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,
Composite of readmission for acute HF or new ACS (hospitalization or >24 hours of stay in the Emergency Department) or death from any cause.
Measured: Up to 30 days since prior revascularization
Acute renal injury during hospitalization
Acute Kidney Injury Network (AKIN) criteria I, II or III or hemodialysis requirement
Measured: During hospitalization due to prior STEMI, after revascularization and LUS performance.
Development of atrial fibrilation/flutter during hospitalization
New-onset atrial fibrillation or atrial flutter during hospitalization in patients without prior history of these arrhythmias.
Measured: During hospitalization due to prior STEMI, after revascularization and LUS performance.
Ventilatory support during hospitalization
Need of ventilatory support (invasive or non-invasive mechanical ventilation) during hospitalization.
Measured: During hospitalization due to prior STEMI, after revascularization and LUS performance.
Development of arrhythmias during follow-up
New-onset atrial fibrillation, atrial flutter, sustained ventricular tachycardia or ventricular fibrillation during hospitalization and during follow-up.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start15 Jun 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Hospital del Mar d'Investigacions Médiques, Hospital Vall d'Hebron
- Responsible party
- Sponsor
- Investigators
- Jose Carreras-Mora, MD., Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526535
- Sponsor's protocol ID
- IIBSP-ECO-2019-105
- Acronym
- LUS-AMI
- Status last verified
- Feb 2023
- First submitted
- 24 Jul 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
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.
PubMed 26033127Pivetta 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 Rizzo P, Ferrera P, Pecetto PF, Moiraghi C, Morello F, Steri F, Ciccone G, Calasso C, Caserta MA, Civita M, Condo' C, D'Alessandro V, Del Colle S, Ferrero S, Griot G, Laurita E, Lazzero A, Lo Curto F, Michelazzo M, Nicosia V, Palmari N, Ricchiardi A, Rolfo A, Rostagno R, Bar F, Boero E, Frascisco M, Micossi I, Mussa A, Stefanone V, Agricola R, Cordero G, Corradi F, Runzo C, Soragna A, Sciullo D, Vercillo D, Allione A, Artana N, Corsini F, Dutto L, Lauria G, Morgillo T, Tartaglino B, Bergandi D, Cassetta I, Masera C, Garrone M, Ghiselli G, Ausiello L, Barutta L, Bernardi E, Bono A, Forno D, Lamorte A, Lison D, Lorenzati B, Maggio E, Masi I, Maggiorotto M, Novelli G, Panero F, Perotto M, Ravazzoli M, Saglio E, Soardo F, Tizzani A, Tizzani P, Tullio M, Ulla M, Romagnoli E; SIMEU Group for Lung Ultrasound in the Emergency Department in Piedmont. Lung Ultrasound-Implemented Diagnosis of Acute Decompensated Heart Failure in the ED: A SIMEU Multicenter Study. Chest. 2015 Jul;148(1):202-210. doi: 10.1378/chest.14-2608.
PubMed 25654562Lichtenstein 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: 10.1097/00000542-200401000-00006.
PubMed 14695718Coiro 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):1172-81. doi: 10.1002/ejhf.344. Epub 2015 Sep 29.
PubMed 26417699Platz 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;37(15):1244-51. doi: 10.1093/eurheartj/ehv745. Epub 2016 Jan 26.
PubMed 26819225Rivas-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 randomized controlled clinical trial (LUS-HF study). Eur J Heart Fail. 2019 Dec;21(12):1605-1613. doi: 10.1002/ejhf.1604. Epub 2019 Oct 31.
PubMed 31667987Januzzi 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 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.
PubMed 16293638Platz 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, Mueller C; Study Group on Acute Heart Failure of the Acute Cardiovascular Care Association and the Heart Failure Association of the European Society of Cardiology. Expert consensus document: Reporting checklist for quantification of pulmonary congestion by lung ultrasound in heart failure. Eur J Heart Fail. 2019 Jul;21(7):844-851. doi: 10.1002/ejhf.1499. Epub 2019 Jun 19.
PubMed 31218825Ye 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.
PubMed 31287587Araujo 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-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2020 Jun;13(6):e010269. doi: 10.1161/CIRCIMAGING.119.010269. Epub 2020 Jun 15.
PubMed 32536197Carreras-Mora J, Vidal-Burdeus M, Rodriguez-Gonzalez C, Simon-Ramon C, Rodriguez-Sotelo L, Sionis A, Giralt-Borrell T, Martinez-Membrive MJ, Izquierdo-Marquisa A, Farre N, Cainzos-Achirica M, Tizon-Marcos H, Garcia-Picart J, Mila-Pascual L, Vaquerizo-Montilla B, Rivas-Lasarte M, Ribas-Barquet N. Lung Ultrasound in the Acute Phase of ST-Segment-Elevation Acute Myocardial Infarction: 1-Year Prognosis and Improvement in Risk Prediction. J Am Heart Assoc. 2024 Nov 5;13(21):e035688. doi: 10.1161/JAHA.124.035688. Epub 2024 Oct 29.
PubMed 39470045
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)
- ClinicalTrials.gov ID
- NCT04526535
- Acronym / sponsor ID
- LUS-AMI / IIBSP-ECO-2019-105
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Keywords
- Lung Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Institut Hospital del Mar d'Investigacions Médiques, Hospital Vall d'Hebron
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No B-lines | – | Diagnostic Test: Lung ultrasoundPatients 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) |
| B lines | – | Diagnostic Test: Lung ultrasoundPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults admitted with STEMI during 1 year in three terciary centers who meet inclusion criteria.
Key inclusion criteria (1 listed)
- Adults (more than 18 years) admitted with confirmed ST-segment elevation acute myocardial infarction (STEMI).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundLung ultrasound performed with a portable device with an 8 zones protocol within the first 24 hours after and ST-segment elevation acute myocardial infarction | Diagnostic test | B lines, No B-lines |
Primary outcome
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.
6 secondary outcomes
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.
Combined endpoint in a short follow-up: heart failure, acute coronary syndrome or death,
Time frame: 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.
Development of atrial fibrilation/flutter during hospitalization
Time frame: 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.
Development of arrhythmias during follow-up
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Results publicationFarré 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.
- Results publicationAraujo 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.
- Results publication: PubMed 26033127Lichtenstein 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.
- Results publication: PubMed 25654562Pivetta 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 Rizzo P, Ferrera P, Pecetto PF, Moiraghi C, Morello F, Steri F, Ciccone G, Calasso C, Caserta MA, Civita M, Condo' C, D'Alessandro V, Del Colle S, Ferrero S, Griot G, Laurita E, Lazzero A, Lo Curto F, Michelazzo M, Nicosia V, Palmari N, Ricchiardi A, Rolfo A, Rostagno R, Bar F, Boero E, Frascisco M, Micossi I, Mussa A, Stefanone V, Agricola R, Cordero G, Corradi F, Runzo C, Soragna A, Sciullo D, Vercillo D, Allione A, Artana N, Corsini F, Dutto L, Lauria G, Morgillo T, Tartaglino B, Bergandi D, Cassetta I, Masera C, Garrone M, Ghiselli G, Ausiello L, Barutta L, Bernardi E, Bono A, Forno D, Lamorte A, Lison D, Lorenzati B, Maggio E, Masi I, Maggiorotto M, Novelli G, Panero F, Perotto M, Ravazzoli M, Saglio E, Soardo F, Tizzani A, Tizzani P, Tullio M, Ulla M, Romagnoli E; SIMEU Group for Lung Ultrasound in the Emergency Department in Piedmont. Lung Ultrasound-Implemented Diagnosis of Acute Decompensated Heart Failure in the ED: A SIMEU Multicenter Study. Chest. 2015 Jul;148(1):202-210. doi: 10.1378/chest.14-2608.
- Results publication: PubMed 14695718Lichtenstein 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: 10.1097/00000542-200401000-00006.
- Results publication: PubMed 26417699Coiro 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):1172-81. doi: 10.1002/ejhf.344. Epub 2015 Sep 29.
- Results publication: PubMed 26819225Platz 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;37(15):1244-51. doi: 10.1093/eurheartj/ehv745. Epub 2016 Jan 26.
- Results publication: PubMed 31667987Rivas-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 randomized controlled clinical trial (LUS-HF study). Eur J Heart Fail. 2019 Dec;21(12):1605-1613. doi: 10.1002/ejhf.1604. Epub 2019 Oct 31.
- Results publication: PubMed 16293638Januzzi 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 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17.
- Results publication: PubMed 31218825Platz 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, Mueller C; Study Group on Acute Heart Failure of the Acute Cardiovascular Care Association and the Heart Failure Association of the European Society of Cardiology. Expert consensus document: Reporting checklist for quantification of pulmonary congestion by lung ultrasound in heart failure. Eur J Heart Fail. 2019 Jul;21(7):844-851. doi: 10.1002/ejhf.1499. Epub 2019 Jun 19.
- Results publication: PubMed 31287587Ye 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.
- Results publication: PubMed 32536197Araujo 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-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2020 Jun;13(6):e010269. doi: 10.1161/CIRCIMAGING.119.010269. Epub 2020 Jun 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Carreras-Mora, MD. principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Heart Failure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526535, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.