Pulmonary EmbolismNCT03672123
GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 270 participants
- Where
- 1 sitePoland
- Study dates
- 17 Sep 2018to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study will recruit 270 patients.
Who may be able to join
- Adult patients with APE hospitalized who give written consent.
Who cannot join
- lack of informed consent
- APE with symptoms lasting above 14 days before the admission
- acute coronary syndrome, diagnosed pulmonary hypertension
- severe valve disease
- sepsis
- active malignancy
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- diagnosed mitochondrial diseases
- chronic kidney disease at least stage 4 (KDIGO)
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw
Warsaw, 02-005
About this study
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.
Read the detailed description
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism (APE).
In APE right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. Growth differentiation factor 15 (GDF-15) is a chemokine secreted by activated macrophages in response to oxidative stress. It has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of GDF-15 in cardiac myocytes. The objective of this project is to describe the role of GDF-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of GDF-15 are associated with more advanced right ventricle dysfunction and failure.
- Conditions
- Pulmonary Embolism
- 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 |
|---|---|---|
| APE with RVD | RVD (right ventricle disfunction) defined according to ESC (European Society of Cardiology) criteria | |
| APE without RVD | RVD defined according to ESC criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic deterioration
Hemodynamic deterioration defined according to ESC criteria as:
change in blood pressure defined as: drop in systolic arterial blood pressure < 90 mmHg or at least 40 mmHg, lasting ≤ than 15 minutes
Measured: assessed daily through study completion, average of 10 days
Secondary outcomes (1)
Hemorrhagic complications
Major bleeding defined according to ISTH (International Society on Thrombosis and Haemostasis) criteria.
Measured: assessed daily through study completion, average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start17 Sep 2018
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Center, Poland
- Responsible party
- Principal investigator, Marta Skowronska, Medical University of Warsaw
- Investigators
- Marta Z Skowronska, MD, Principal investigator, Medical University of WarsawPiotr Pruszczyk, Prof., Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672123
- Sponsor's protocol ID
- GDF-15 APE
- Status last verified
- Oct 2023
- First submitted
- 5 Sep 2018
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03672123
- Acronym / sponsor ID
- GDF-15 APE
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- National Science Center, Poland
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Sep 2018 (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.
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.
Detailed description
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism (APE).
In APE right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. Growth differentiation factor 15 (GDF-15) is a chemokine secreted by activated macrophages in response to oxidative stress. It has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of GDF-15 in cardiac myocytes. The objective of this project is to describe the role of GDF-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of GDF-15 are associated with more advanced right ventricle dysfunction and failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APE with RVD | – | –RVD (right ventricle disfunction) defined according to ESC (European Society of Cardiology) criteria |
| APE without RVD | – | –RVD defined according to ESC criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 270 patients.
Key inclusion criteria (1 listed)
- Adult patients with APE hospitalized who give written consent.
Key exclusion criteria (9 listed)
- lack of informed consent
- APE with symptoms lasting above 14 days before the admission
- acute coronary syndrome, diagnosed pulmonary hypertension
- severe valve disease
- sepsis
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
hemodynamic deterioration
Time frame: assessed daily through study completion, average of 10 days
Hemodynamic deterioration defined according to ESC criteria as: change in blood pressure defined as: drop in systolic arterial blood pressure < 90 mmHg or at least 40 mmHg, lasting ≤ than 15 minutes
1 secondary outcome
Hemorrhagic complications
Time frame: assessed daily through study completion, average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marta Z Skowronska, MD principal investigator
Medical University of Warsaw
Piotr Pruszczyk, Prof. study director
Medical University of Warsaw
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, run by Medical University of Warsaw 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 31 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic deterioration (time frame: assessed daily through study completion, average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2023.