Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 815
- Locations
- 6
- Primary Endpoint
- Right ventricular dysfunction (RVD)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18 years or older with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation will be eligible for enrollment.
Exclusion Criteria
- •Patients who refuse consent for 30-day clinical contact and follow-up.
Outcomes
Primary Outcomes
Right ventricular dysfunction (RVD)
Time Frame: Index visit
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
Clinical Deterioration
Time Frame: 5 days
Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.
Secondary Outcomes
- Pulmonary Embolism Complications(30 days)
- Functional Outcome(30 days)