Studies

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

  • 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
  • UOC di Cardiologia, Ospedali Riuniti Padova Sud, Monselice, Italia, Monselice, Italy (Recruiting)
    • Marco Zuin, MD MS
  • 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
  • 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)
  • 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
  • UO di Cardiologia, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy (Recruiting)
    • Giuseppe Musumeci, MD
    • Giuseppe Musumeci, MD (Principal Investigator)
  • 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