Optimal Time for Reperfusion in Acute Pulmonary Embolism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda ULSS 8 Berica
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with a confirmed diagnosis of high-risk or intermediate-high-risk pulmonary embolism according to the 2019 European Society of Cardiology guidelines.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Patients with intermediate-high or high-risk pulmonary embolism
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 30 daysSecondary outcomes
1
Complications
Association between different reperfusion time windows and techniques and the occurrence of haemorrhagic or cardiovascular complications among patients with intermediate-high and high-risk with acute pulmonary embolism
Time frame
From enrollment to the end of treatment at 30 daysSponsors and contacts
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Source ClinicalTrials.gov