Pulmonary Embolism With Acute Cor PulmonalePolPERTsNCT04879069
Polish Multicenter PERTs PE Outcomes Registry
An observational study of Pulmonary Embolism With Acute Cor Pulmonale, run by Poznan University of Medical Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism With Acute Cor Pulmonale
- How many people
- 10,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2018to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients hospitalized due to high-risk or intermediate-high risk PE.
Who may be able to join
- 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.
Who cannot join
- 1. Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, GreaterPoland, 61-848
Aleksander Araszkiewicz, Prof., 8549149 ext. +48, aaraszkiewicz@ump.edu.pl
Sylwia Sławek-Szmyt, MD, PhD, sylwia.slawek@skpp.edu.pl
About this study
Official title: Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
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.
Read the 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.
- Keywords
- pulmonary embolism, pulmonary embolism response team,
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intermediate-high risk PE | Confirmed PE causing right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level | |
| High-risk PE | 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement during hospitalization
Incidence of arterial blood saturation increase >92%
Measured: 24 hours after specific PE treatment implementation
Ventricular strain reduction
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
Measured: 24 hours after specific PE treatment implementation
Early mortality rate from pulmonary embolism
Number of patients who died from pulmonary embolism (right heart failure)
Measured: Two weeks since PE diagnosis
Secondary outcomes (2)
Total mortality rate from pulmonary embolism
Number of patients who died from pulmonary embolism (right heart failure)
Measured: 3 months since PE diagnosis
Bleeding events incidence
Incidence of major bleedings assessed using ISTH criteria
Measured: 3 months since PE diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Jun 2018
- Primary completionJun 2023 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism With Acute Cor PulmonaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Cardiac Society
- Responsible party
- Principal investigator, Aleksander Araszkiewicz, Poznan University of Medical Sciences
- Investigators
- Aleksander Araszkiewicz, Prof., Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879069
- Sponsor's protocol ID
- 276/21
- Acronym
- PolPERTs
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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/s12931-025-03162-4.
PubMed 40045310
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
- ClinicalTrials.gov ID
- NCT04879069
- Acronym / sponsor ID
- PolPERTs / 276/21
- Keywords
- pulmonary embolism, pulmonary embolism response team,
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Polish Cardiac Society
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermediate-high risk PE | – | –Confirmed PE causing right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level |
| High-risk PE | – | –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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients hospitalized due to high-risk or intermediate-high risk PE.
Key inclusion criteria (7 listed)
- PE confirmed by computed tomography pulmonary angiography.
- PE symptoms duration ≤ 14 days.
- High-risk PE with hemodynamic instability (one of):
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by imaging studies and elevated troponin level.
Key exclusion criteria (1 listed)
- 1. Refusal to sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical improvement during hospitalization
Time frame: 24 hours after specific PE treatment implementation
Incidence of arterial blood saturation increase >92%
Ventricular strain reduction
Time frame: 24 hours after specific PE treatment implementation
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
Early mortality rate from pulmonary embolism
Time frame: Two weeks since PE diagnosis
Number of patients who died from pulmonary embolism (right heart failure)
2 secondary outcomes
Total mortality rate from pulmonary embolism
Time frame: 3 months since PE diagnosis
Bleeding events incidence
Time frame: 3 months since PE diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 40045310Slawek-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/s12931-025-03162-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksander Araszkiewicz, Prof. principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism With Acute Cor Pulmonale, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksander Araszkiewicz (8549146 ext. +48, aaraszkiewicz@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement during hospitalization (time frame: 24 hours after specific PE treatment implementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.