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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Pulmonary Embolism

Study type

Observational

Funder types

Other

Identifiers

NCT02883491
07-16-06E
IRB00082655

Details and patient eligibility

About

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.

Full 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.

Enrollment

815 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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