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RECRUITING
NCT07855679

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

Sponsor: Azienda Ospedaliero-Universitaria Careggi

View on ClinicalTrials.gov

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.

Official title: The PERSEUS Registry - Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2023-01-01

Completion Date

2032-07

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

OTHER

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

Locations (9)

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, Italy

Ospedale Santo Stefano - Azienda USL Toscana Centro

Prato, Tuscany, Italy

AORN Antonio Cardarelli

Naples, Italy

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

Perugia, Italy

Azienda Ospedaliero-Universitaria Pisana - Ospedale Cisanello

Pisa, Italy

AOU Città della Salute e della Scienza di Torino - Presidio Molinette

Torino, Italy

Ospedale Versilia - Azienda USL Toscana Nord Ovest

Viareggio, Italy

Medical University of Warsaw - Infant Jesus Teaching Hospital

Warsaw, Poland

Hospital Universitario Ramón y Cajal

Madrid, Spain