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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
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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Bova, MD | Azienda Ospedaliera di Cosenza | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedalier di Cosenza "SS.Annunziata" | Cosenza | 87100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36695397 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2019 | Jun 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |