Pulmonary Embolism Clinical Trial
— PEDISOfficial title:
Prevalence of Pulmonary Embolism (PE) Among Patients Referred to Emergency Departments for Dyspnea on Exertion
Verified date | March 2021 |
Source | Arianna Anticoagulazione Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 400 |
Est. completion date | January 30, 2021 |
Est. primary completion date | December 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedalier di Cosenza "SS.Annunziata" | Cosenza |
Lead Sponsor | Collaborator |
---|---|
Arianna Anticoagulazione Foundation |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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