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

NCT07855679 | Recruiting

• 2 other identifiers: PERSEUS30742_oss
• Study Type: observational
• Target: 5,000
• Locations: 3 countries
• Sites: 9

Brief 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. 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. 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. 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.

Conditions

Pulmonary Embolism Acute; Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Chronic Thromboembolic Pulmonary Hypertension; Right Ventricular Dysfunction; Pulmonary Embolism (Diagnosis); Pulmonary Embolism Subacute Massive; Pulmonary Embolism and Thrombosis; Pulmonary Embolism With Right Ventricle Enlargement; Pulmonary Embolism, Deep Vein Thrombosis

Keywords

Pulmonary Embolism; Acute Pulmonary Embolism; Venous Thromboembolism; Right Ventricular Dysfunction; Risk Stratification; Prognostic Scores; TELOS-plus; sPESI; Bova Score; ESC Guidelines; AHA/ACC Guidelines; High-Sensitivity Troponin; Plasma Lactate; Echocardiography; CT Pulmonary Angiography; Hemodynamic Decompensation; Systemic Thrombolysis; Catheter-Directed Therapy; Observational Registry; Real-World Evidence; Emergency Department

Outcome Measures

Primary Outcomes (2)

• Incidence of 30-Day All-Cause Mortality

  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.

  From index pulmonary embolism diagnosis up to 30 days

• Incidence of 30-Day Pulmonary Embolism (PE)-Related Mortality

  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.

  From index pulmonary embolism diagnosis up to 30 days

Secondary Outcomes (5)

• Incidence of Early In-Hospital Hemodynamic Decompensation

  From hospital presentation up to hospital discharge or maximum 30 days

• Incidence of 30-Day Major Bleeding Events

  From index pulmonary embolism diagnosis up to 30 days

• Incidence of Confirmed Recurrent Venous Thromboembolism (VTE)

  From index diagnosis up to 5 years of follow-up

• Incidence of Clinically Relevant Non-Major Bleeding (CRNMB)

  From index pulmonary embolism diagnosis up to 30 days

• Incidence of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Post-PE Syndrome

  Assessed during routine follow-up visits at 3 months, 12 months, and annually up to 5 years

Study Arms (1)

Adult patients presenting to the ED confirmed diagnosis of acute pulmonary embolism

Other: Standard medical treatment

Interventions

Standard medical treatment OTHER

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

Also known as: Routine Clinical Practice, Usual Care

Adult patients presenting to the ED confirmed diagnosis of acute pulmonary embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients presenting to the emergency departments, high-dependency units, intensive care units, or acute inpatient medical and cardiology wards of participating academic tertiary medical centers and regional hospitals with objectively confirmed acute pulmonary embolism. The registry captures the entire real-world clinical spectrum across both retrospective and contemporary prospective cohorts.

You may qualify if:

• 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) where transport for definitive imaging is unsafe or unfeasible: bedside point-of-care ultrasound (POCUS) / echocardiography demonstrating acute right ventricular overload in combination with confirmed proximal DVT or mobile right heart thromboemboli.
• 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.

You may not qualify if:

• \* Current active enrollment in an interventional experimental drug trial (blinded randomized clinical trial) where active drug allocation or protocol-mandated therapeutic regimen is unknown.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead
• University of Florence: collaborator
• Azienda USL Toscana Centro: collaborator
• A.O.U. Città della Salute e della Scienza: 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

Study Sites (9)

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

RECRUITING

Ospedale Santo Stefano - Azienda USL Toscana Centro

Prato, Tuscany, 59100, Italy

RECRUITING

AORN Antonio Cardarelli

Naples, 80131, Italy

RECRUITING

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

Perugia, 06129, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana - Ospedale Cisanello

Pisa, Italy

RECRUITING

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

Torino, 10126, Italy

RECRUITING

Ospedale Versilia - Azienda USL Toscana Nord Ovest

Viareggio, Italy

RECRUITING

Medical University of Warsaw - Infant Jesus Teaching Hospital

Warsaw, Poland

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Ventricular Dysfunction, Right; Pulmonary Embolism; Disease; Thrombosis; Emergencies

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Simone Vanni, MD, PhD

  Azienda Ospedaliero-Universitaria Careggi / University of Florence

  PRINCIPAL INVESTIGATOR

• Matteo Gabriele Monda, MD

  Azienda Ospedaliero-Universitaria Careggi / University of Florence

  STUDY DIRECTOR

Central Study Contacts

Simone Vanni, MD, PhD

CONTACT

+393666904459; simone.vanni@unifi.it

Matteo Gabriele Monda, MD

CONTACT

+393209433394; matteogabriele.monda@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, High Dependency Unit (OSAI) & Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: January 1, 2023
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2032
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 12 months after formal publication of the primary registry outcomes manuscript and will remain accessible for a period of 5 years.
• Access Criteria: Access requests must be submitted in writing to the Principal Investigator (simone.vanni@unifi.it) and the PERSEUS Steering Committee, including a detailed scientific protocol and statistical analysis plan. Proposals will be evaluated for scientific merit, feasibility, ethical compliance, and non-redundancy by the Steering Committee. Prior to data release, requestors and their home institutions must sign a formal Data Transfer Agreement (DTA) with Azienda Ospedaliero-Universitaria Careggi and obtain appropriate local ethical approval.

Locations

ES (1); IT (7); PL (1)