NCT02883491

Pulmonary Embolism Short-term Clinical Outcomes Registry

Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 815 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Embolism

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-02-20
• Completion: 2019-02-20
• First posted: 2016-08-30
• Last updated: 2022-04-26

Locations

6 sites across 1 country: United States