Pulmonary Embolism Short-term Clinical Outcomes Registry

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT02883491
• Lead Sponsor: Wake Forest University Health Sciences

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Primary Completion: 2019-02-20
• Study Completion: 2019-02-20
• Status Verified: 2020-01
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 815

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.

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Exclusion Criteria

• Patients who refuse consent for 30-day clinical contact and follow-up.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right ventricular dysfunction (RVD)	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	5 days	Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.

Secondary Outcome Measures

Name	Time	Method
Pulmonary Embolism Complications	30 days	Presence of any one variable: recurrence of pulmonary embolism, subsequent hospitalizations, major and minor bleeding
Functional Outcome	30 days	Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire

Trial Locations

Locations (6)

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

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

Carolinas Healthcare System; 🇺🇸 Charlotte, North Carolina, United States

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States