Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)

Poznan University of Medical Sciences (PUMS)

Status: Enrolling

Conditions: Pulmonary Embolism With Acute Cor Pulmonale

Study type: Observational

Funder types: Other

Identifiers

NCT04879069

276/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10,000 participants in 2 patient groups

Intermediate-high risk PE

Description:

Confirmed PE causing right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level

High-risk PE

Description:

Confirmed PE causing hemodynamic instability: 1. Cardiac arrest (need for cardiopulmonary resuscitation) or, 2. Obstructive shock (systolic blood pressure \< 90 mmHg or vasopressors required to achieve a systolic blood pressure ≥90 mmHg despite adequate filling status and end-organ hypoperfusion), or 3. Persistent hypotension (systolic blood pressure \< 90 mmHg for at least 15 minutes)