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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• All-cause mortality at 30 days — 30 days after diagnosis
  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 — 30 days after diagnosis
  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.

Trial sites (16)

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