Pulmonary Embolism Short-term Clinical Outcomes Registry

Pulmonary Embolism Clinical Trial

— PE-SCOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883491
• Other study ID #: IRB00082655
• Secondary ID: 07-16-06E
• Status: Completed
• Start date: August 2016
• Est. completion date: February 20, 2019

Study information

• Verified date: January 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
United States	Carolinas Healthcare System	Charlotte	North Carolina
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Christiana Care Health System	Newark	Delaware
United States	Orlando Regional Medical Center	Orlando	Florida
United States	University of Utah Hospital	Salt Lake City	Utah
United States	San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Deterioration	Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.	5 days
Primary	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	Functional Outcome	Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire	30 days
Secondary	Pulmonary Embolism Complications	Presence of any one variable: recurrence of pulmonary embolism, subsequent hospitalizations, major and minor bleeding	30 days