Pulmonary Embolism Short-term Clinical Outcomes Registry

NCT ID: NCT02883491

Last Updated: 2022-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

815 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-02-20

Brief Summary

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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

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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.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Weekes, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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San Diego Medical Center

San Diego, California, United States

Site Status

Christiana Care Health System

Newark, Delaware, United States

Site Status

Orlando Regional Medical Center

Orlando, Florida, United States

Site Status

Carolinas Healthcare System

Charlotte, North Carolina, United States

Site Status

Vanderbilt Medical Center

Nashville, Tennessee, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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07-16-06E

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00082655

Identifier Type: -

Identifier Source: org_study_id

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