Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI) (LUS-AMI)
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| ClinicalTrials.gov Identifier: NCT04526535 |
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Recruitment Status :
Completed
First Posted : August 26, 2020
Last Update Posted : March 1, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Acute Myocardial Infarction Heart Failure | Diagnostic Test: Lung ultrasound |
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 |
| Actual Enrollment : | 400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI) |
| Actual Study Start Date : | June 15, 2020 |
| Actual Primary Completion Date : | December 31, 2022 |
| Actual Study Completion Date : | December 31, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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)
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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 |
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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)
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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 |
- 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.
- 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).
- 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.
- 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
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526535
| Spain | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Spain | |
| Hospital del Mar | |
| Barcelona, Spain | |
| Principal Investigator: | Jose Carreras-Mora, MD. | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Responsible Party: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| ClinicalTrials.gov Identifier: | NCT04526535 |
| Other Study ID Numbers: |
IIBSP-ECO-2019-105 |
| First Posted: | August 26, 2020 Key Record Dates |
| Last Update Posted: | March 1, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lung Ultrasound |
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Myocardial Infarction Infarction Heart Diseases Cardiovascular Diseases Ischemia |
Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases |