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NCT07855679
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Conditions: Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension, Right Ventricular Dysfunction, Pulmonary Embolism (PE)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 5000
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Location: Ospedale Santa Maria Annunziata - Azienda USL Toscana Centro Bagno a Ripoli Tuscany
Summary
PERSEUS is an academic, investigator-initiated, multicenter observational registry of adults with acute pulmonary embolism (PE), promoted by Azienda Ospedaliero-Universitaria Careggi (Florence, Italy). It collects data generated during routine care across the whole course of the disease: pre-hospital care when available, emergency department presentation, the hospital stay (including bedside reassessments in the first 48 hours when performed as part of care) and follow-up up to 5 years. The registry has a retrospective cohort (patients diagnosed from 1 January 2023 until local ethics committee approval, with data taken from medical records) and a prospective cohort (consecutive patients enrolled after approval). Taking part in the registry does not change patient care: all tests and treatments are decided by the treating physicians. The registry aims to describe how acute PE is managed in everyday practice and how often patients die (from any cause and from PE), deteriorate hemodynamically, have recurrent venous thromboembolism or bleeding, and develop long-term complications such as chronic thromboembolic pulmonary hypertension. The database also supports ancillary analyses with separate pre-specified analysis plans, such as the evaluation of existing risk-stratification tools.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older at the time of presentation.
* Objectively confirmed diagnosis of acute pulmonary embolism (PE), with or without concomitant deep vein thrombosis (DVT) of the lower or upper extremities, confirmed by at least one of the following methods:
* Computed tomography pulmonary angiography (CTPA) demonstrating intraluminal filling defects in the pulmonary arterial tree;
* Ventilation/perfusion (V/Q) lung scintigraphy demonstrating high-probability mismatch;
* Conventional catheter-directed pulmonary angiography;
* In hemodynamically unstable patients (obstructive shock or cardiac arrest) in whom definitive imaging is not feasible: bedside point-of-care ultrasound showing clear signs of right ventricular overload together with proximal deep vein thrombosis, or mobile right heart thrombi.
* For the retrospective cohort: availability of medical records documenting clinical presentation and index diagnostic work-up at baseline (T0). The absence of serial reassessment timepoints (T1-T4) does not constitute an exclusion criterion.
* Written informed consent obtained from the patient or legal surrogate, or waiver/exception under Article 110-bis of the Italian Privacy Code (and applicable institutional ethical clearance) for deceased or untraceable patients.
Exclusion Criteria:
* Current active enrollment in an interventional experimental drug trial (blinded randomized clinical trial) where active drug allocation or protocol-mandated therapeutic regimen is unknown.
Source: ClinicalTrials.gov (NCT07855679). StuddyBuddy aggregates publicly available trial information.