Pulmonary Embolism Short-term Clinical Outcomes Registry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02883491

Acronym

PE-SCOR

Enrollment

815

Registered

2016-08-30

Start date

2016-08-31

Completion date

2019-02-20

Last updated

2022-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Deterioration	5 days	Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.
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

Secondary

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

Countries

United States

Outcome results