Best time for reperfusion in acute pulmonary embolism
Optimal Time for Reperfusion in Acute Pulmonary Embolism
This study will test whether performing reperfusion (systemic thrombolysis or catheter‑directed therapy) earlier improves survival and reduces complications in adults with high‑risk or intermediate‑high‑risk pulmonary embolism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda ULSS 8 Berica Academic / other |
| Locations | 7 sites (Milan, Milano and 6 other locations) |
| Trial ID | NCT07436702 on ClinicalTrials.gov |
What this trial studies
This is a national, multicenter, prospective observational study enrolling adults with imaging‑confirmed high‑risk or intermediate‑high‑risk pulmonary embolism at participating Italian centers. Investigators will record timing from symptom onset and hospital admission to reperfusion with systemic thrombolysis or catheter‑directed therapies and track in‑hospital mortality as well as hemorrhagic and cardiovascular complications. Time‑to‑treatment analyses will be used to identify temporal cutoffs associated with better outcomes while accounting for comorbidities and bleeding risk. The goal is to provide evidence on whether a specific reperfusion time window is associated with improved short‑term clinical outcomes.
Who should consider this trial
Good fit: Adults (≥18 years) with imaging‑confirmed high‑risk or intermediate‑high‑risk pulmonary embolism who can provide informed consent and are treated at participating centers.
Not a fit: Patients with low‑risk PE, chronic stable PE, those who cannot receive reperfusion therapies, or those treated outside participating centers are unlikely to receive direct benefit from this study's findings.
Why it matters
Potential benefit: If successful, defining an optimal reperfusion time window could increase survival and reduce hemodynamic collapse and bleeding by guiding earlier treatment decisions.
How similar studies have performed: Systemic thrombolysis and catheter‑directed therapies are established for selected high‑risk PE, but prospective, multicenter evidence specifically defining optimal timing is limited and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan, Milano and 6 other locations
- UO Unità di Cure Intensive Cardiologiche e Cardiologia 1, Ospedale Niguarda, Milano — Milan, Milano, Italy (Recruiting)
- UOC di Cardiologia, Ospedali Riuniti Padova Sud, Monselice, Italia — Monselice, Padova, Italy (Recruiting)
- IRCCS Policlinico San Matteo — Pavia, Pavia, Italy (Recruiting)
- UO di Sezione di Medicina Interna e Cardiovascolare, Ospedale Santa Maria della Misericordia, Perugia, Italia — Perugia, Perugia, Italy (Recruiting)
- UO di Cardiologia 1, Azienda Ospedaliero Universitaria Pisana, Pisa, Italia — Pisa, Pisa, Italy (Recruiting)
- UO di Cardiologia, Azienda Ospedaliera Ordine Mauriziano di Torino — Torino, Torino, Italy (Recruiting)
- UOC di Cardiologia, Ospedali dell'Ovest Vicentino, Arzignano, IItalia — Arzignano, Vicenza, Italy (Recruiting)
Study contacts
- Principal investigator: Claudio Bilato, MD PhD — Department of Cardiology, Azienda AULSS 8 Berica, Arzignano (Vicenza), Italy
- Study coordinator: Claudio Bilato, MD PhD
- Email: claudio.bilato@aulss8.veneto.it
- Phone: +390444479106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.