NCT04526535

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

July 24, 2020

Last Update Submit

February 28, 2023

Conditions

Acute Myocardial InfarctionHeart Failure

Keywords

Lung Ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    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,

    Up to 30 days since prior revascularization

  • Acute renal injury during hospitalization

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

  • Development of atrial fibrilation/flutter during hospitalization

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

  • Ventilatory support during hospitalization

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

  • +1 more secondary outcomes

Study Arms (2)

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

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

Interventions

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

B linesNo B-lines

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Adults (more than 18 years) admitted with confirmed ST-segment elevation acute myocardial infarction (STEMI).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Related Publications (13)

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 26033127RESULT

  • 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 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.

    PMID: 25654562RESULT

  • 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: 10.1097/00000542-200401000-00006.

    PMID: 14695718RESULT

  • 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):1172-81. doi: 10.1002/ejhf.344. Epub 2015 Sep 29.

    PMID: 26417699RESULT

  • 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;37(15):1244-51. doi: 10.1093/eurheartj/ehv745. Epub 2016 Jan 26.

    PMID: 26819225RESULT

  • 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 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.

    PMID: 31667987RESULT

  • 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 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.

    PMID: 16293638RESULT

  • 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, 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.

    PMID: 31218825RESULT

  • 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.

    PMID: 31287587RESULT

  • 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-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2020 Jun;13(6):e010269. doi: 10.1161/CIRCIMAGING.119.010269. Epub 2020 Jun 15.

    PMID: 32536197RESULT

  • Carreras-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.

    PMID: 39470045DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jose Carreras-Mora, MD.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

August 26, 2020

Study Start

June 15, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)