The overall goal of this clinical research study is to prospectively assess primary outcomes related to pulmonary embolism (PE) that occur immediately (within 5 days) and within 30 days. The secondary goal is to compare validated prediction models and a modified European Society of Cardiology (ESC) approach that is primarily right ventricle dysfunction (RVD) driven with clinical risk assessment being secondary, and with primary outcomes of clinical deterioration within 5 days.
The investigators wish to develop the Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR). The investigators also wish to determine the incidence of death and circulatory and respiratory deterioration, and administration of reperfusion therapy within 5 days in PE patients. The study will also evaluate the sensitivity, specificity and positive and negative predictive values of each RVD assessment option. The investigators will also derive a prediction model for PE patients for the primary outcome within five days. Finally, investigators will determine the functional outcomes of PE patients 30 days after PE.
Study Type
OBSERVATIONAL
Enrollment
815
San Diego Medical Center
San Diego, California, United States
Christiana Care Health System
Newark, Delaware, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Clinical Deterioration
Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.
Time frame: 5 days
Right ventricular dysfunction (RVD)
Presence of any one indicator of RVD: any one goal directed echocardiography finding of RVD (right ventricle (RV) enlargement or, leftward deviation of the interventricular septum, or RV systolic dysfunction by longitudinal movement of the tricuspid annulus of the RV free wall), CT right ventricle : left ventricle ratio greater or equal to 1, positive troponin or B-type Natriuretic Peptide, EKG injury and ischemia patterns of RVD
Time frame: Index visit
Functional Outcome
Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Time frame: 30 days
Pulmonary Embolism Complications
Presence of any one variable: recurrence of pulmonary embolism, subsequent hospitalizations, major and minor bleeding
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vanderbilt Medical Center
Nashville, Tennessee, United States
University of Utah Hospital
Salt Lake City, Utah, United States