Optimal Time for Reperfusion in Acute Pulmonary Embolism

NCT07436702 | Recruiting

• 1 other identifier: OPTIRAPE - 775CET 2026
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

Brief Summary

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality worldwide. Current guidelines recommend early reperfusion for high-risk and intermediate-high-risk PE, yet systemic thrombolysis and percutaneous therapies are frequently underutilized, and no specific timing for reperfusion is defined, unlike in acute myocardial infarction or ischemic stroke. As most PE-related in-hospital deaths occur within the first hours and thrombus composition changes over time, defining an optimal reperfusion time window may improve survival and prevent hemodynamic deterioration. We therefore propose a national, multicenter, prospective observational study to evaluate the prognostic impact of reperfusion timing, using systemic thrombolysis or catheter-directed therapies, on in-hospital mortality and haemorrhagic or cardiovascular complications.

Conditions

Pulmonary Embolism (Diagnosis); Pulmonary Embolism Acute

Keywords

Fibrinolysis; Anticoagulation; Catheter-directed treatments; Time of Reperfusion

Outcome Measures

Primary Outcomes (1)

• Mortality

  Correlation between time to reperfusion (measured in hours from hospital admission to initiation of systemic thrombolysis or catheter-directed therapies \[CDTs\]) and in-hospital mortality rate (rate of patients) among patients with intermediate-high- and high-risk acute pulmonary embolism.

  From enrollment to the end of treatment at 30 days

Secondary Outcomes (1)

• Complications

  From enrollment to the end of treatment at 30 days

Study Arms (1)

Patients with intermediate-high or high-risk pulmonary embolism

Patients with intermediate-high or high-risk pulmonary embolism stratified according to the ESC 2019 guidelines

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

Patients with a confirmed diagnosis of high-risk or intermediate-high-risk pulmonary embolism according to the 2019 European Society of Cardiology guidelines.

You may qualify if:

• Age ≥ 18 years
• Patients with a diagnosis of intermediate-high or high pulmonary embolism confirmed by computed tomography pulmonary angiography (CTPA), pulmonary angiography, or echocardiography (evidence of a floating thrombus in the right atrium or right ventricle, or proximal visualization of thrombus in the pulmonary artery).
• Classified as high-risk or intermediate-high-risk according to the 2019 European Society of Cardiology guidelines.
• Provision of informed consent for the processing of personal data.

You may not qualify if:

• Age \< 18 years
• Patients in whom a diagnosis of acute high-risk or intermediate-high-risk pulmonary embolism has been excluded.
• Inability to provide informed consent.

Sponsors & Collaborators

• Azienda ULSS 8 Berica: lead

Study Sites (7)

UO Unità di Cure Intensive Cardiologiche e Cardiologia 1, Ospedale Niguarda, Milano

Milan, Milano, 20162, Italy

RECRUITING

UOC di Cardiologia, Ospedali Riuniti Padova Sud, Monselice, Italia

Monselice, Padova, 35043, Italy

RECRUITING

IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

UO di Sezione di Medicina Interna e Cardiovascolare, Ospedale Santa Maria della Misericordia, Perugia, Italia

Perugia, Perugia, 06129, Italy

RECRUITING

UO di Cardiologia 1, Azienda Ospedaliero Universitaria Pisana, Pisa, Italia

Pisa, Pisa, 56126, Italy

RECRUITING

UO di Cardiologia, Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, Torino, 10128, Italy

RECRUITING

UOC di Cardiologia, Ospedali dell'Ovest Vicentino, Arzignano, IItalia

Arzignano, Vicenza, 36071, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Zuin, MD MS

  Department of Translational Medicine, University of Ferrara, Italy

  STUDY DIRECTOR

• Claudio Bilato, MD PhD

  Department of Cardiology, Azienda AULSS 8 Berica, Arzignano (Vicenza), Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Bilato, MD PhD

CONTACT

+390444479106; claudio.bilato@aulss8.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: November 25, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)