Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism

NCT05050617 | Recruiting

• 1 other identifier: 1793729-1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational, prospective study examining the role point-of-care echocardiography of predicting short term adverse outcomes in emergency department patients with acute pulmonary embolism. The primary objective is to assess the diagnostic performance of ultrasound-guided measures of right ventricular dilation (RVD) and strain in predicting clinical outcomes in acute PE. The secondary objective is to investigate the utility of combining ultrasound-guided measures of RVD and the pulmonary embolism severity index (PESI) score in predicting adverse outcomes in acute PE.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Adverse Events at 5 days

  Composite of recurrent/worsening VTE (including PE or DVT), new cardiac dysrhythmia, major bleeding, return to the ED, death or need for critical interventions (including advanced cardiac life support, advanced respiratory support, vasopressor support, thrombolysis or new oxygen requirement occurring after initial presentation) occurring within 5 days of acute PE diagnosis

  Within 5 days of presentation/enrollment

Secondary Outcomes (3)

• Adverse Events during Index Hospitalization

  Between time of presentation/enrollment and discharge from index hospitalization

• Adverse Events within 14 days

  Within 14 days of presentation/enrollment

• Adverse Events within 30 days

  Within 30 days of presentation/enrollment

Study Arms (1)

Acute Pulmonary Embolism

Subjects in this single cohort will undergo point-of-care echocardiography at the time of presentation and subsequent follow up to assess for short term adverse events or complications.

Diagnostic Test: Point-of-care echocardiography

Interventions

Point-of-care echocardiography DIAGNOSTIC_TEST

Subjects will undergo point-of-care echocardiography at the time of presentation/enrollment to assess for evidence of right sided heart dilation/strain.

Acute Pulmonary Embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of ED patients over the age of 18 who have an acute pulmonary embolism identified on CT imaging.

You may qualify if:

• Age \>= 18 years of age
• ED diagnosis of acute pulmonary embolism with identification on CT imaging

You may not qualify if:

• Age \<18 years of age
• Inability to provide informed consent
• Incarceration
• Current PE previously diagnosed prior to index ED visit

Sponsors & Collaborators

• WellSpan Health: lead
• Stony Brook University: collaborator
• University of California, Irvine: collaborator

Study Sites (1)

Wellspan York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

Related Publications (11)

• Alerhand S, Hickey SM. Tricuspid Annular Plane Systolic Excursion (TAPSE) for Risk Stratification and Prognostication of Patients with Pulmonary Embolism. J Emerg Med. 2020 Mar;58(3):449-456. doi: 10.1016/j.jemermed.2019.09.017. Epub 2019 Nov 15.

  PMID: 31735658 BACKGROUND

• Aujesky D, Perrier A, Roy PM, Stone RA, Cornuz J, Meyer G, Obrosky DS, Fine MJ. Validation of a clinical prognostic model to identify low-risk patients with pulmonary embolism. J Intern Med. 2007 Jun;261(6):597-604. doi: 10.1111/j.1365-2796.2007.01785.x.

  PMID: 17547715 BACKGROUND

• Carley S, Dosman S, Jones SR, Harrison M. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J. 2005 Mar;22(3):180-1. doi: 10.1136/emj.2003.011148.

  PMID: 15735264 BACKGROUND

• Chan CM, Woods C, Shorr AF. The validation and reproducibility of the pulmonary embolism severity index. J Thromb Haemost. 2010 Jul;8(7):1509-14. doi: 10.1111/j.1538-7836.2010.03888.x. Epub 2010 Apr 16.

  PMID: 20403093 BACKGROUND

• Ciurzynski M, Kurnicka K, Lichodziejewska B, Kozlowska M, Plywaczewska M, Sobieraj P, Dzikowska-Diduch O, Goliszek S, Bienias P, Kostrubiec M, Pruszczyk P. Tricuspid Regurgitation Peak Gradient (TRPG)/Tricuspid Annulus Plane Systolic Excursion (TAPSE) - A Novel Parameter for Stepwise Echocardiographic Risk Stratification in Normotensive Patients With Acute Pulmonary Embolism. Circ J. 2018 Mar 23;82(4):1179-1185. doi: 10.1253/circj.CJ-17-0940. Epub 2018 Jan 26.

  PMID: 29375106 BACKGROUND

• Daley J, Grotberg J, Pare J, Medoro A, Liu R, Hall MK, Taylor A, Moore CL. Emergency physician performed tricuspid annular plane systolic excursion in the evaluation of suspected pulmonary embolism. Am J Emerg Med. 2017 Jan;35(1):106-111. doi: 10.1016/j.ajem.2016.10.018. Epub 2016 Oct 11.

  PMID: 27793505 BACKGROUND

• Donze J, Le Gal G, Fine MJ, Roy PM, Sanchez O, Verschuren F, Cornuz J, Meyer G, Perrier A, Righini M, Aujesky D. Prospective validation of the Pulmonary Embolism Severity Index. A clinical prognostic model for pulmonary embolism. Thromb Haemost. 2008 Nov;100(5):943-8. doi: 10.1160/th08-05-0285.

  PMID: 18989542 BACKGROUND

• Hariharan P, Takayesu JK, Kabrhel C. Association between the Pulmonary Embolism Severity Index (PESI) and short-term clinical deterioration. Thromb Haemost. 2011 Apr;105(4):706-11. doi: 10.1160/TH10-09-0577. Epub 2011 Jan 12.

  PMID: 21225095 BACKGROUND

• Kurzyna M, Torbicki A, Pruszczyk P, Burakowska B, Fijalkowska A, Kober J, Oniszh K, Kuca P, Tomkowski W, Burakowski J, Wawrzynska L. Disturbed right ventricular ejection pattern as a new Doppler echocardiographic sign of acute pulmonary embolism. Am J Cardiol. 2002 Sep 1;90(5):507-11. doi: 10.1016/s0002-9149(02)02523-7.

  PMID: 12208411 BACKGROUND

• Rydman R, Soderberg M, Larsen F, Alam M, Caidahl K. d-Dimer and simplified pulmonary embolism severity index in relation to right ventricular function. Am J Emerg Med. 2013 Mar;31(3):482-6. doi: 10.1016/j.ajem.2012.09.016. Epub 2012 Nov 12.

  PMID: 23154103 BACKGROUND

• Shafiq Q, Moukarbel GV, Gupta R, Hernandez DA, Khouri SJ. Practical echocardiographic approach for risk stratification of patients with acute pulmonary embolism. J Echocardiogr. 2016 Dec;14(4):146-155. doi: 10.1007/s12574-016-0306-4. Epub 2016 Aug 10.

  PMID: 27510333 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brent A Becker, MD

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent A Becker, MD

CONTACT

717 851 4819; bbecker2@wellspan.org

Kristen Oliff, BS

CONTACT

717 851 4104; koliff@wellspan.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Department of Emergency Medicine

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 20, 2021
• Study Start: September 9, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

US (1)