About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years of age
ED diagnosis of acute pulmonary embolism with identification on CT imaging
Disqualifiers
Age <18 years of age
Inability to provide informed consent
Incarceration
Current PE previously diagnosed prior to index ED visit
Trial population
The study population consists of ED patients over the age of 18 who have an acute pulmonary embolism identified on CT imaging.
Trial design
Cohort
Prospective
Treatments tested in this trial
Point-of-care echocardiography
Diagnostic testSubjects will undergo point-of-care echocardiography at the time of presentation/enrollment to assess for evidence of right sided heart dilation/strain.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Adverse Events during Index Hospitalization
Composite of mortality, major bleeding or recurrent/worsening PE during index hospitalization
Adverse Events within 14 days
Composite of mortality, major bleeding or recurrent/worsening PE within 14 days of presentation/enrollment
Adverse Events within 30 days
Composite of mortality, major bleeding or recurrent/worsening PE within 30 days of presentation/enrollment
Sponsors and contacts
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WellSpan Health
Lead sponsor
Stony Brook University
Collaborator
University of California, Irvine
Collaborator