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

NCT04454554 | Completed

• 1 other identifier: FAA O4 5-2018 (PEDIS)
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Embolism

Keywords

Dyspnea; Pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• Prevalence of PE in the overall population

  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

  From the first day of enrollment up to 104 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients who refer to the Emergency Departments of the participating centers will be eligible for the study provided they are older than 18 and younger than 75 years, and have developed one or more episodes of exertional dyspnea since less than one month.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arianna Anticoagulazione Foundation: lead

Study Sites (1)

Azienda Ospedalier di Cosenza "SS.Annunziata"

Cosenza, 87100, Italy

Location

Related Publications (1)

• Prandoni P, Lensing AWA, Prins MH, Ciammaichella M, Pirillo S, Pace F, Zalunardo B, Bottino F, Ageno W, Muiesan ML, Forlin M, Depietri L, Bova C, Costantini N, Caviglioli C, Migliaccio L, Noventa F, Levi M, Davidson BL, Palareti G; Pulmonary Embolism Dyspnea Italian Study (PEDIS) Investigators. Prevalence of pulmonary embolism among patients with recent onset of dyspnea on exertion. A cross-sectional study. J Thromb Haemost. 2023 Jan;21(1):68-75. doi: 10.1016/j.jtha.2022.09.007. Epub 2022 Dec 22.

  PMID: 36695397 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo Bova, MD

  Azienda Ospedaliera di Cosenza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: September 24, 2018
• Primary Completion: December 24, 2020
• Study Completion: January 30, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

IT (1)