Recruiting

Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance

ClinicalTrials.gov IDNCT07855679

PhaseNot Applicable

Enrollment5000

SponsorAzienda Ospedaliero-Universitaria Careggi

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension, Right Ventricular Dysfunction, Pulmonary Embolism (PE)

About this study

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.

Interventions

Other: Routine clinical care (no study intervention) — Observational registry. Diagnostic and therapeutic management (laboratory tests, imaging, bedside ultrasound, anticoagulation, reperfusion and hemodynamic support) is entirely at the discretion of the treating physicians, according to routine institutional pathways and international guidelines. The registry only collects data generated in routine care.

Primary outcomes

All-cause mortality at 30 days (30 days after diagnosis)
PE-related mortality at 30 days (30 days after diagnosis)

Eligibility information

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.

Study locations

Ospedale Santa Maria Annunziata - Azienda USL Toscana Centro, Bagno a Ripoli, Tuscany 50012 Italy
Nuovo Ospedale del Mugello - Azienda USL Toscana Centro, Borgo San Lorenzo, Tuscany 50032 Italy
Ospedale San Giuseppe - Azienda USL Toscana Centro, Empoli, Tuscany 50053 Italy
Ospedale Santa Maria Nuova - Azienda USL Toscana Centro, Florence, Tuscany 50122 Italy
Azienda Ospedaliero-Universitaria Careggi, Florence, Tuscany 50134 Italy
Ospedale San Giovanni di Dio (Torregalli) - Azienda USL Toscana Centro, Florence, Tuscany 50143 Italy
Ospedale Santi Cosma e Damiano - Azienda USL Toscana Centro, Pescia, Tuscany 51017 Italy
Ospedale San Jacopo - Azienda USL Toscana Centro, Pistoia, Tuscany 51100 Italy
Ospedale Santo Stefano - Azienda USL Toscana Centro, Prato, Tuscany 59100 Italy
Ospedale Versilia - Azienda USL Toscana Nord Ovest, Lido di Camaiore, Italy

Showing 10 of 16 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.