Polish Multicenter PERTs PE Outcomes Registry

Recruiting

• Conditions: Pulmonary Embolism With Acute Cor Pulmonale

• Registration Number: NCT04879069
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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.

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Last Update Submitted: 2021-05-04
• Study First Posted: 2021-05-10
• Last Update Posted: 2021-05-10
• Primary Completion: 2023-06
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1. PE confirmed by computed tomography pulmonary angiography.

2. PE symptoms duration ≤ 14 days.

3. High-risk PE with hemodynamic instability (one of):

   • cardiac arrest
   • obstructive shock
   • persistent hypotension.

4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular strain reduction	24 hours after specific PE treatment implementation	Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
Clinical improvement during hospitalization	24 hours after specific PE treatment implementation	Incidence of arterial blood saturation increase \>92%
Early mortality rate from pulmonary embolism	Two weeks since PE diagnosis	Number of patients who died from pulmonary embolism (right heart failure)

Secondary Outcome Measures

Name	Time	Method
Total mortality rate from pulmonary embolism	3 months since PE diagnosis	Number of patients who died from pulmonary embolism (right heart failure)
Bleeding events incidence	3 months since PE diagnosis	Incidence of major bleedings assessed using ISTH criteria

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznań, GreaterPoland, Poland