Pulmonary Embolism Short-term Clinical Outcomes Registry

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego Medical Center, San Diego, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Clinical Deterioration

Time frame: 5 days

Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.
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

Secondary outcomes

Functional Outcome

Time frame: 30 days

Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Pulmonary Embolism Complications

Time frame: 30 days

Presence of any one variable: recurrence of pulmonary embolism, subsequent hospitalizations, major and minor bleeding

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: PE-SCOR

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Aug 30, 2016
Registry last updated: Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed