Observational Recruiting
NCT07436702 on ClinicalTrials.gov
Optimal Time for Reperfusion in Acute Pulmonary Embolism
- Sponsor: Azienda ULSS 8 Berica
- Enrollment: 500 (Estimated)
- Study start: 2025-11-25 (Actual)
- Primary completion: 2026-10-30 (Estimated)
- Study completion: 2026-10-30 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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
Primary Outcome Measures
-
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.
Countries
Italy
Locations and Investigators
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UO Unità di Cure Intensive Cardiologiche e Cardiologia 1, Ospedale Niguarda, Milano, Milan, Italy (Recruiting)
- Claudia Colombo, MD
- Claudia Colombo, MD (Principal Investigator)
- Alice Sacco, MD
- Fabrizio Oliva, MD
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UOC di Cardiologia, Ospedali Riuniti Padova Sud, Monselice, Italia, Monselice, Italy (Recruiting)
- Marco Zuin, MD MS
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IRCCS Policlinico San Matteo, Pavia, Italy (Recruiting)
- Leonardo De Luca, MD PhD
- Leonardo De Luca, MD PhD (Principal Investigator)
- Stefano Ghio, MD PhD
- Guido Tavazzi, MD PhD
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UO di Sezione di Medicina Interna e Cardiovascolare, Ospedale Santa Maria della Misericordia, Perugia, Italia, Perugia, Italy (Recruiting)
- Cecilia Becattini, MD PhD
- Maria Cristina Vedovati, MD PhD
- Cecilia Becattini, MD PhD (Principal Investigator)
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UO di Cardiologia 1, Azienda Ospedaliero Universitaria Pisana, Pisa, Italia, Pisa, Italy (Recruiting)
- Rosalinda Madonna, MD PhD
- Rosalinda Madonna, MD PhD (Principal Investigator)
- Raffaele De Caterina, MD PhD
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UO di Cardiologia, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy (Recruiting)
- Giuseppe Musumeci, MD
- Giuseppe Musumeci, MD (Principal Investigator)
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UOC di Cardiologia, Ospedali dell'Ovest Vicentino, Arzignano, IItalia, Arzignano, Italy (Recruiting)
- Claudio Bilato, MD PhD
- Claudio Bilato, MD PhD (Principal Investigator)
- Chiara Dalla Valle, MD
Study Officials
- Marco Zuin, MD MS (Study Director) — Department of Translational Medicine, University of Ferrara, Italy
- Claudio Bilato, MD PhD (Principal Investigator) — Department of Cardiology, Azienda AULSS 8 Berica, Arzignano (Vicenza), Italy