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.
Age 18 years or older at the time of presentation.
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;
Current active enrollment in an interventional experimental drug trial (blinded randomized clinical trial) where active drug allocation or protocol-mandated therapeutic regimen is unknown.
Consecutive adults with objectively confirmed acute pulmonary embolism diagnosed at participating hospitals, from emergency department presentation through hospitalization, including patients presenting with obstructive shock or cardiac arrest.
Cohort
Other
Routine clinical care (no study intervention)
Other interventionObservational 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.
All-cause mortality at 30 days
Proportion of patients who die from any cause within 30 days of the objectively confirmed diagnosis of acute pulmonary embolism. Vital status is ascertained from hospital records, review of clinical documentation and, when needed, regional mortality registries.
PE-related mortality at 30 days
Proportion of patients whose death within 30 days is adjudicated as a direct consequence of the index or a recurrent pulmonary embolism (PE). Fatal PE is defined as death occurring after objectively confirmed PE (index or recurrent event) in the absence of other identifiable causes, or confirmed at autopsy. For deaths occurring at home, information on the cause of death is actively sought.
Hemodynamic decompensation
Proportion of patients with new occurrence, after the initial assessment, of at least one of: persistent hypotension (systolic blood pressure \<90 mmHg for 15 minutes or longer) or shock; need for continuous vasopressor or inotrope infusion; invasive mechanical ventilation; cardiac arrest; rescue reperfusion therapy (systemic, catheter-directed or surgical) for clinical deterioration. Reperfusion given as the initial treatment strategy is not counted as an event.
All-cause mortality during follow-up
Proportion of patients who die from any cause during follow-up.
PE-related mortality during follow-up
Proportion of patients whose death during follow-up is adjudicated as a direct consequence of the index or a recurrent pulmonary embolism, as defined for the 30-day PE-related mortality outcome.
Recurrent venous thromboembolism
Proportion of patients with any new episode of pulmonary embolism or deep vein thrombosis (lower or upper limb, proximal or distal) confirmed by objective testing. Superficial vein thrombosis is not counted.
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Azienda Ospedaliero-Universitaria Careggi
Lead sponsor
University of Florence
Collaborator
Azienda USL Toscana Centro
Collaborator
Azienda Ospedaliera di Perugia
Collaborator
Cardarelli Hospital, Naples, Italy
Collaborator
Azienda Ospedaliero, Universitaria Pisana
Collaborator
Azienda USL Toscana Nord Ovest
Collaborator
Medical University of Warsaw
Collaborator
Hospital Universitario Ramon y Cajal
Collaborator
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Collaborator
