Clinical trial NCT04879069: Polish Multicenter PERTs PE Outcomes Registry
Official title: Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism With Acute Cor Pulmonale
Keywords: pulmonary embolism, pulmonary embolism response team,
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Polish Cardiac Society
First posted: 2021-05-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients hospitalized due to high-risk or intermediate-high risk PE.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical improvement during hospitalization
timeFrame: 24 hours after specific PE treatment implementation
measure: Ventricular strain reduction
timeFrame: 24 hours after specific PE treatment implementation
measure: Early mortality rate from pulmonary embolism
timeFrame: Two weeks since PE diagnosis
Secondary outcomes:
measure: Total mortality rate from pulmonary embolism
timeFrame: 3 months since PE diagnosis
measure: Bleeding events incidence
timeFrame: 3 months since PE diagnosis
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
state: GreaterPoland
Study officials:
affiliation: Poznan University of Medical Sciences
name: Aleksander Araszkiewicz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: