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Adrenomedullin in Context With Pulmonary Embolism

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ClinicalTrials.gov Identifier: NCT04875130
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
University of Pecs

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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). 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).


Condition or disease Intervention/treatment
Pulmonary Embolism Diagnostic Test: blood samples

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adrenomedullin in Context With the Diagnose of Pulmonary Embolism and Its Positive / Negative Predictive Value
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Diagnostic Test: blood samples
Taking blood samples (plasma, serum) and measure the level of Adrenomedullin


Outcome Measures
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Primary Outcome Measures :
  1. 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. Additionally, the change of vital parameters/other blood results are examined e.g.:

    • blood pressure
    • pulse
    • routine lab (Hb, erythrocytes, thrombocytes, leucocytes, etc.)
    • Brain Natriuretic Peptide (BNP)/ N-terminale pro Brain Natriuretic Peptide (pro-NT-BNP)


Secondary Outcome Measures :
  1. 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) ]
    Comparing CT-angiography imaging, clinical presentation and ADM-level to evaluate correlation between the ADM-level and the severity of the pulmonary embolism.


Biospecimen Retention:   Samples With DNA
plasma serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • emergency ward
  • cardial observation ward
  • internal medicine ward
  • intensive care ward
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age under 18.
  • Missing written agreement or cancelled agreement on any time.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875130


Contacts
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Contact: Dominik Hinterreiter, MD +436603733643 D.Hinterreiter@gmx.net
Contact: Diana Mühl, MD +3672535832 drdianamuhl@gmail.com

Locations
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Austria
KRAGES - Hospital of Oberwart Recruiting
Oberwart, Burgenland, Austria, 7400
Contact: Dominik Hinterreiter, MD    +436603733643    D.Hinterreiter@gmx.net   
Hungary
University Hospital of Pécs Recruiting
Pécs, Baranya, Hungary, 7624
Contact: Diana Mühl, MD    +3672535832    drdianamuhl@gmail.com   
Sponsors and Collaborators
University of Pecs
Investigators
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Study Chair: Lajos Bogár, MD University of Pécs - School of Medicine
More Information
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Additional Information:

Publications of Results:

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Responsible Party: University of Pecs
ClinicalTrials.gov Identifier: NCT04875130    
Other Study ID Numbers: PTE/8424-2/2020
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pecs:
Pulmonary Embolism
Adrenomedullin
Biomarker
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases