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OpenTrials
Completed

NCT Number: NCT04454554

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedalier di Cosenza "SS.Annunziata"

Cosenza, 87100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of PE in the overall population

    Time frame: From the first day of enrollment up to 104 weeks

    Prevalence 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

Sponsors and collaborators

Lead sponsor

Arianna Anticoagulazione Foundation

Other

Registry information

Official study title

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

Acronym: PEDIS

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 1, 2020
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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