Polish Multicenter PERTs PE Outcomes Registry

Pulmonary Embolism With Acute Cor Pulmonale Clinical Trial

— PolPERTs  

Official title:

Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879069
• Other study ID #: 276/21
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: December 2030

Study information

• Verified date: May 2021
• Source: Poznan University of Medical Sciences
• Contact: Aleksander Araszkiewicz
• Phone: 8549146
• Email: aaraszkiewicz[@]ump.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2030
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Pulmonary Embolism With Acute Cor Pulmonale
• Pulmonary Heart Disease

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	GreaterPoland

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	Polish Cardiac Society

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement during hospitalization	Incidence of arterial blood saturation increase >92%	24 hours after specific PE treatment implementation
Primary	Ventricular strain reduction	Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography	24 hours after specific PE treatment implementation
Primary	Early mortality rate from pulmonary embolism	Number of patients who died from pulmonary embolism (right heart failure)	Two weeks since PE diagnosis
Secondary	Total mortality rate from pulmonary embolism	Number of patients who died from pulmonary embolism (right heart failure)	3 months since PE diagnosis
Secondary	Bleeding events incidence	Incidence of major bleedings assessed using ISTH criteria	3 months since PE diagnosis