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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism

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 Type: Observational
• Enrollment (Actual): 815

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • San Diego Medical Center
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Healthcare System
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who present to the Emergency Department (ED) with image confirmed acute pulmonary embolism diagnosed within 12 hours of presentation.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Deterioration	Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.	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	Index visit

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): February 20, 2019

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: IRB00082655; 07-16-06E (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No