Pulmonary EmbolismNCT04875130
Adrenomedullin in Context With Pulmonary Embolism
An observational study of Pulmonary Embolism, run by University of Pecs at 2 sites in 2 countries.
Trial summary
The pulmonary embolism (PE) causes a blockade of the pulmonary arteries typical due to a thrombus which is formed in the lower region of the body or pretty rare to other materials (tumor, air, fat). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- blood samples
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Aug 2020to 8 May 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: * emergency ward * cardial observation ward * internal medicine ward * intensive care ward
Who may be able to join
- Patients with intermediate high and high risk of an acute pulmonary embolism with clinical symptoms.
- On image based procedures confirmed pulmonary embolism (TTE, contrast CT-angiography).
- Written agreement to the examination.
Who cannot join
- Age under 18.
- Missing written agreement or cancelled agreement on any time.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Adrenomedullin in Context With the Diagnose of Pulmonary Embolism and Its Positive / Negative Predictive Value
The pulmonary embolism (PE) causes a blockade of the pulmonary arteries typical due to a thrombus which is formed in the lower region of the body or pretty rare to other materials (tumor, air, fat). The working group plans to evaluate the pathology of the thromboembolism in the case of a partial, subtotal or even total pulmonary embolism. The acute PE is still often in the adult population and in many accompanied by death. Etiological the problem occurs through an acute right ventricular failure and leads into severe pulmonal perfusion disorder with shock and hypoxemia. The right diagnose is pretty hard in the clinical day because all symptoms are common and unspecific. To provide the best treatment in short time it is needed to sum up all the symptoms and evaluate the risk of an acute pulmonary embolism and it's morbidity.
The easiest and fastest way treating a PE is to apply a systemic intravenous thrombolysis but bleeding complications are the most common and most frequently side effects. The decision-making process in patients without shock is pretty hard because of having no clear diagnose. Lab parameters and imaging (CT angiography) is important for the best decision in critical ill PE patients but time is sometimes missing.
Read more
A possible new biomarker in identifying a PE is adrenomedullin.
Elevated adenomedullin levels in septic patients with left ventricular heart failure, severe dyspnoea and intubated patients are well known, but in the case of PE it wasn't analysed yet. Human adrenomedullin is a protein with 52 amino acid which is produced in the lung and first extracted in the adrenal gland. The sequence homology is pretty similar to the Calcitonin-Gene-Related-Peptide (CGRP)-protein superfamily (vasodilatation). Its precursor is named pro-adrenomedullin peptide and it shows a significant weaker vasodilatation activity compaired to adrenomedullin. Adrenomedullin causes severe hypotonia in scientific studies where it was applied as an intravenous bolus or infusion. This vasodilatation effect concern to the systemic and as well in the pulmonary circulation. Its vasodilatation mechanism is not clarified yet.
The trial is defined as an prospective study, where the investigators would like to measure/analyse the adrenomeulline level in PE patients in the intermediate high and high risk population. The diagnose and treatment of the patients is fixed to the European Society of Cardiology (ESC) recommendations of the cardiology society of 2019 Guidelines on Acute Pulmonary Embolism (Diagnosis and Management of Pulmonary Embolism).
- Conditions
- Pulmonary Embolism
- Being tested
- blood samples
- Keywords
- Pulmonary Embolism, Adrenomedullin, Biomarker
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesDiagnostic test
Taking blood samples (plasma, serum) and measure the level of Adrenomedullin
| Study group | Role | What they receive |
|---|---|---|
| confirmed pulmonary embolism | * Patients with intermediate high and high risk of an acute pulmonary embolism with clinical symptoms.
* On image based procedures confirmed pulmonary embolism (TTE, contrast CT-angiography).
* Age under 18.
* Written agreement to the examination. Receives: Diagnostic Test: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is Adrenomedullin (ADM) a useful new biomarker in the diagnose of pulmonary embolism?
Measurement: ADM-Kit (ELISA technique) measures the trend level (pg/ml) during observation time.
- 4 samples are taken
Measured: admission - 5th day (change in the baseline)
Secondary outcomes (1)
Is it possible to quantify the severity of pulmonary embolism, because of knowing the elevation of adrenomedullin in systemic circulation failure?
Comparing CT-angiography imaging, clinical presentation and ADM-level to evaluate correlation between the ADM-level and the severity of the pulmonary embolism.
Measured: through study completion (2 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start19 Aug 2020
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lajos Bogár, MD, Study chair, University of Pécs - School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875130
- Sponsor's protocol ID
- PTE/8424-2/2020
- Status last verified
- May 2023
- First submitted
- 27 Apr 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voors AA, Kremer D, Geven C, Ter Maaten JM, Struck J, Bergmann A, Pickkers P, Metra M, Mebazaa A, Dungen HD, Butler J. Adrenomedullin in heart failure: pathophysiology and therapeutic application. Eur J Heart Fail. 2019 Feb;21(2):163-171. doi: 10.1002/ejhf.1366. Epub 2018 Dec 28.
PubMed 30592365Nishikimi T, Nakagawa Y. Adrenomedullin as a Biomarker of Heart Failure. Heart Fail Clin. 2018 Jan;14(1):49-55. doi: 10.1016/j.hfc.2017.08.006. Epub 2017 Oct 7.
PubMed 29153200Geven C, Kox M, Pickkers P. Adrenomedullin and Adrenomedullin-Targeted Therapy As Treatment Strategies Relevant for Sepsis. Front Immunol. 2018 Feb 19;9:292. doi: 10.3389/fimmu.2018.00292. eCollection 2018.
PubMed 29520277
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenomedullin in Context With the Diagnose of Pulmonary Embolism and Its Positive / Negative Predictive Value
- ClinicalTrials.gov ID
- NCT04875130
- Acronym / sponsor ID
- PTE/8424-2/2020
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Adrenomedullin, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 6 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.
The pulmonary embolism (PE) causes a blockade of the pulmonary arteries typical due to a thrombus which is formed in the lower region of the body or pretty rare to other materials (tumor, air, fat). The working group plans to evaluate the pathology of the thromboembolism in the case of a partial, subtotal or even total pulmonary embolism. The acute PE is still often in the adult population and in many accompanied by death. Etiological the problem occurs through an acute right ventricular failure and leads into severe pulmonal perfusion disorder with shock and hypoxemia. The right diagnose is pretty hard in the clinical day because all symptoms are common and unspecific. To provide the best treatment in short time it is needed to sum up all the symptoms and evaluate the risk of an acute pulmonary embolism and it's morbidity.
The easiest and fastest way treating a PE is to apply a systemic intravenous thrombolysis but bleeding complications are the most common and most frequently side effects. The decision-making process in patients without shock is pretty hard because of having no clear diagnose. Lab parameters and imaging (CT angiography) is important for the best decision in critical ill PE patients but time is sometimes missing.
A possible new biomarker in identifying a PE is adrenomedullin.
Elevated adenomedullin levels in septic patients with left ventricular heart failure, severe dyspnoea and intubated patients are well known, but in the case of PE it wasn't analysed yet. Human adrenomedullin is a protein with 52 amino acid which is produced in the lung and first extracted in the adrenal gland. The sequence homology is pretty similar to the Calcitonin-Gene-Related-Peptide (CGRP)-protein superfamily (vasodilatation). Its precursor is named pro-adrenomedullin peptide and it shows a significant weaker vasodilatation activity compaired to adrenomedullin. Adrenomedullin causes severe hypotonia in scientific studies where it was applied as an intravenous bolus or infusion. This vasodilatation effect concern to the systemic and as well in the pulmonary circulation. Its vasodilatation mechanism is not clarified yet.
The trial is defined as an prospective study, where the investigators would like to measure/analyse the adrenomeulline level in PE patients in the intermediate high and high risk population. The diagnose and treatment of the patients is fixed to the European Society of Cardiology (ESC) recommendations of the cardiology society of 2019 Guidelines on Acute Pulmonary Embolism (Diagnosis and Management of Pulmonary Embolism).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| confirmed pulmonary embolism | – | Diagnostic Test: blood samples* Patients with intermediate high and high risk of an acute pulmonary embolism with clinical symptoms. * On image based procedures confirmed pulmonary embolism (TTE, contrast CT-angiography). * Age under 18. * Written agreement to the examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * emergency ward * cardial observation ward * internal medicine ward * intensive care ward
Key inclusion criteria (3 listed)
- Patients with intermediate high and high risk of an acute pulmonary embolism with clinical symptoms.
- On image based procedures confirmed pulmonary embolism (TTE, contrast CT-angiography).
- Written agreement to the examination.
Key exclusion criteria (2 listed)
- Age under 18.
- Missing written agreement or cancelled agreement on any time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesTaking blood samples (plasma, serum) and measure the level of Adrenomedullin | Diagnostic test | confirmed pulmonary embolism |
Primary outcome
Is Adrenomedullin (ADM) a useful new biomarker in the diagnose of pulmonary embolism?
Time frame: admission - 5th day (change in the baseline)
Measurement: ADM-Kit (ELISA technique) measures the trend level (pg/ml) during observation time. - 4 samples are taken
1 secondary outcome
Is it possible to quantify the severity of pulmonary embolism, because of knowing the elevation of adrenomedullin in systemic circulation failure?
Time frame: through study completion (2 year)
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 11 May 2023.
- Results publication: PubMed 30592365Voors AA, Kremer D, Geven C, Ter Maaten JM, Struck J, Bergmann A, Pickkers P, Metra M, Mebazaa A, Dungen HD, Butler J. Adrenomedullin in heart failure: pathophysiology and therapeutic application. Eur J Heart Fail. 2019 Feb;21(2):163-171. doi: 10.1002/ejhf.1366. Epub 2018 Dec 28.
- Results publication: PubMed 29153200Nishikimi T, Nakagawa Y. Adrenomedullin as a Biomarker of Heart Failure. Heart Fail Clin. 2018 Jan;14(1):49-55. doi: 10.1016/j.hfc.2017.08.006. Epub 2017 Oct 7.
- Results publication: PubMed 29520277Geven C, Kox M, Pickkers P. Adrenomedullin and Adrenomedullin-Targeted Therapy As Treatment Strategies Relevant for Sepsis. Front Immunol. 2018 Feb 19;9:292. doi: 10.3389/fimmu.2018.00292. eCollection 2018.
- Pulmonary embolism in adultsLink provided by the sponsor.
- 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.
Lajos Bogár, MD study chair
University of Pécs - School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by University of Pecs at 2 sites in 2 countries.
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 3 inclusion and 2 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Hungary. 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?
Is Adrenomedullin (ADM) a useful new biomarker in the diagnose of pulmonary embolism? (time frame: admission - 5th day (change in the baseline)). 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 NCT04875130, which also lists 3 linked publications.
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 11 May 2023.