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Recruiting Observational

Optimal Time for Reperfusion in Acute Pulmonary Embolism

NCT07436702 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-11-25
Last updated
2026-03-03

Condition(s) studied

Pulmonary Embolism (Diagnosis)Pulmonary Embolism Acute

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Mortality — From enrollment to the end of treatment at 30 days
    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.

Trial sites (7)

FacilityCityRegionStatus
UO Unità di Cure Intensive Cardiologiche e Cardiologia 1, Ospedale Niguarda, Milano Milan Milano Recruiting
UOC di Cardiologia, Ospedali Riuniti Padova Sud, Monselice, Italia Monselice Padova Recruiting
IRCCS Policlinico San Matteo Pavia Pavia Recruiting
UO di Sezione di Medicina Interna e Cardiovascolare, Ospedale Santa Maria della Misericordia, Perugia, Italia Perugia Perugia Recruiting
UO di Cardiologia 1, Azienda Ospedaliero Universitaria Pisana, Pisa, Italia Pisa Pisa Recruiting
UO di Cardiologia, Azienda Ospedaliera Ordine Mauriziano di Torino Torino Torino Recruiting
UOC di Cardiologia, Ospedali dell'Ovest Vicentino, Arzignano, IItalia Arzignano Vicenza Recruiting

More Azienda ULSS 8 Berica trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07436702 on ClinicalTrials.gov ↗ ← All trials in Italy