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Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)

Prevalence of Pulmonary Embolism (PE) Among Patients Referred to Emergency Departments for Dyspnea on Exertion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04454554
Acronym
PEDIS
Enrollment
400
Registered
2020-07-01
Start date
2018-09-24
Completion date
2021-01-30
Last updated
2021-03-19

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

Conditions

Pulmonary Embolism

Keywords

Dyspnea, Pulmonary embolism

Brief summary

PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a consecutive series of patients who refer to the Emergency Departments (either spontaneously or sent by their attending physicians) for the recent (less than one months) development of exertional dyspnea. The general aim of the study is to assess the prevalence of PE in the overall population referring to the Emergency Departments without potential explanations for dyspnea

Detailed description

PEDIS Study is an observational, cross-sectional, multicenter and no Profit Study. 600 consecutive patients referring to the Emergency Departments of the participating centers because they have developed one or more episodes of exertional dyspnea since less than one month will be enrolled. All eligible patients will be interviewed and examined by trained study physicians. The presence of already known potential explanations for the dyspnea will be assessed. In addition, symptoms of the lower extremities will be elicited, as well as the presence of risk factors for venous thromboembolism (VTE). The presence or absence of pulmonary embolism will be assessed with the use of a validated algorithm based on pre-test clinical probability and D-dimer result. In patients in whom the pre-test clinical probability is low and the D-dimer result is negative, no further testing will be done, and PE will be considered excluded. In patients with high clinical probability, positive D-dimer result, or both, computed tomography (CT) pulmonary angiography will be performed The primary study objective is to evaluate Prevalence of PE in the overall population

Interventions

None listed

Sponsors

Arianna Anticoagulazione Foundation
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age older than 18 and younger than 75 * Recent (less than one month) development of exertional dyspnea * Able to provide informed consent

Exclusion criteria

* Anticoagulation required for other indications * Contraindication to CT angiography (allergy to the contrast dye, severe renal failure \[creatinine clearance \< 30 ml/min\]) * Involvement in simultaneous clinical trials * Unable to provide their written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of PE in the overall populationFrom the first day of enrollment up to 104 weeksPrevalence of Pulmonary Embolism in patient with high pre-test clinical probability and/or positive D-dimer without potential explanations for the dyspnea who underwent computed tomography pulmonary angiography

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026