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

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard medical treatment: Purely observational documentation of standard-of-care clinical management. Diagnostic procedures (laboratory assays, arterial blood gas, bedside multiorgan ultrasound, echocardiography, CTPA) and therapeutic strategies (anticoagulation, systemic thrombolysis, catheter-directed therapies, hemodynamic support) are performed entirely at the discretion of the attending physicians in accordance with routine institutional pathways and international clinical guidelines. No experimental interventions, treatment allocations, or study-mandated procedures are administered.Standard Clinical Care

Study summary

Acute pulmonary embolism (PE) is a leading cardiovascular cause of emergency department admission and mortality worldwide. While existing registries have described general epidemiological trends and outpatient anticoagulation patterns, there remains a critical evidence gap regarding granular clinical presentation, acute pre-hospital and emergency care, dynamic bedside reassessment, and their direct impact on long-term patient outcomes.

The PERSEUS Registry (Pulmonary Embolism Registry from Short-term Emergency to long-term follow-Up and Surveillance) is an academic, investigator-initiated, multicenter, ambispective (combining retrospective and prospective cohorts), non-interventional observational registry. Promoted by Azienda Ospedaliero-Universitaria Careggi (Florence, Italy) in collaboration with a national and international hospital network, the registry enrolls consecutive adult patients presenting with objectively confirmed acute PE across emergency departments, high-dependency units, and inpatient wards.

The primary objective of PERSEUS is to systematically characterize real-world clinical management and major adverse outcomes across the entire continuum of care-from pre-hospital and initial emergency department triage through dynamic in-hospital serial reassessment (T1-T4 intervals) and long-term follow-up (up to 5 years).

The registry provides an extensive, high-quality centralized data infrastructure to:

1. Determine the contemporary incidence of 30-day all-cause and PE-related mortality, hemodynamic decompensation, recurrent venous thromboembolism (VTE), major bleeding (according to ISTH criteria), and chronic thromboembolic pulmonary hypertension (CTEPH);
2. Externally validate and compare clinical risk-stratification models and prognostic scoring systems (including the TELOS-plus score, simplified PESI, Bova score, ESC 2019 guidelines, and the AHA/ACC 2026 clinical classification);
3. Evaluate the real-world clinical effectiveness and safety of reperfusion therapies (systemic thrombolysis, catheter-directed therapies, and surgical embolectomy) in normotensive intermediate-high risk and hemodynamically unstable patients.

Being strictly observational and non-interventional, patient management is conducted entirely according to routine clinical practice, local protocols, and international clinical guidelines, with no study-mandated interventions or diagnostic tests.

Eligibility

Primary outcome measure(s)

• Incidence of 30-Day All-Cause Mortality — From index pulmonary embolism diagnosis up to 30 days
  Cumulative incidence of death from any cause occurring within 30 days following the index diagnosis of acute pulmonary embolism. Vital status is confirmed through in-hospital clinical records, structured 30-day telephone/outpatient follow-up, or linkage with regional healthcare mortality registries. Patients lost to follow-up without vital status confirmation are censored at the date of last contact and excluded from the complete-case analysis.
• Incidence of 30-Day Pulmonary Embolism (PE)-Related Mortality — From index pulmonary embolism diagnosis up to 30 days
  Cumulative incidence of death adjudicated as directly attributable to the index or recurrent acute pulmonary embolism within 30 days. PE-related death is defined by standardized protocol criteria as: (1) death preceded by documented hemodynamic collapse/obstructive shock directly caused by acute PE; (2) death following objectively confirmed recurrent PE; (3) autopsy-confirmed fatal pulmonary embolism; or (4) unexpected or sudden cardiac arrest occurring in the acute phase where PE cannot be ruled out and no alternative competing cause of death is identifiable.

Trial sites (9)

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