Polish Multicenter PERTs PE Outcomes Registry

Official title

Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry

Overview

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE. All institutionalized PERTs in Poland have been invited to join the study. The goal of this registry is to describe current practice and outcomes in patients with acute PE treated by Polish PERTs.

Detailed description

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The presentation of PE may vary from asymptomatic or mild exertion disturbances (low-risk PE) treated with anticoagulants only to hemodynamic "obstructive" collapse and death (high-risk PE). Patient outcome depends on ability of the right ventricle to sustain the increased afterload caused by the embolic burden. Careful risk stratification is crucial, and the Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE by advancing its recognition, diagnosis, and treatment. All institutionalized PERTs in Poland have been invited to join the study. The data is administrated by the Poznan University of Medical Sciences on the basis of an agreement between the PERT centres.

The goal of this registry is to describe current practice and outcomes in patients with acute PE guided by Polish PERTs. The primary data recorded include details of each patient's clinical status, co-morbidities, the administered treatment modalities, the results of additional studies (ab tests results, ECG, imaging studies), and the outcome.

The data collection will have no impact on the way the patient is diagnosed and treated.The study endpoints comprise respiratory failure, shock, death distal systemic embolization (i.e. stroke) and major or minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification.

Primary outcome measures

• Clinical improvement during hospitalization [Time frame: 24 hours after specific PE treatment implementation]
• Ventricular strain reduction [Time frame: 24 hours after specific PE treatment implementation]
• Early mortality rate from pulmonary embolism [Time frame: Two weeks since PE diagnosis]

Secondary outcome measures (2)

• Total mortality rate from pulmonary embolism [Time frame: 3 months since PE diagnosis]
• Bleeding events incidence [Time frame: 3 months since PE diagnosis]

Eligibility criteria

Inclusion criteria

• PE confirmed by computed tomography pulmonary angiography.
• PE symptoms duration ≤ 14 days.
• High-risk PE with hemodynamic instability (one of):

• cardiac arrest
• obstructive shock
• persistent hypotension.
• Intermediate-high risk PE patients with right ventricle dysfunction confirmed by imaging studies and elevated troponin level.

Exclusion criteria

1\. Refusal to sign the informed consent form.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Poland · 1 center

• Poznan University of Medical Sciences — Poznan

Publications

• Slawek-Szmyt S, Stepniewski J, Kurzyna M, Klaudel J, Kuliczkowski W, Lewandowski M, Grabka M, Roik M, Ordiene R, Jankiewicz S, Kopec G, Darocha S, Mroczek E, Widecka K, Kurzyna P, Lesiak M, Pruszczyk P, Araszkiewicz A. Multicentre, real-world data of next-generation computer-assisted vacuum aspiration thrombectomy in acute pulmonary embolism. Respir Res. 2025 Mar 5;26(1):87. doi: 10.1186/s12931-02 PMID 40045310

Identifiers

NCT: NCT04879069 · 276/21

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗