Clinical trial NCT04875130: Adrenomedullin in Context With Pulmonary Embolism
Official title: Adrenomedullin in Context With the Diagnose of Pulmonary Embolism and Its Positive / Negative Predictive Value
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Adrenomedullin
Biomarker
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * emergency ward
* cardial observation ward
* internal medicine ward
* intensive care ward

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).


Eligibility 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.

Primary outcomes:
measure: Is Adrenomedullin (ADM) a useful new biomarker in the diagnose of pulmonary embolism?
timeFrame: admission - 5th day (change in the baseline)
Secondary outcomes:
measure: Is it possible to quantify the severity of pulmonary embolism, because of knowing the elevation of adrenomedullin in systemic circulation failure?
timeFrame: through study completion (2 year)
Other outcomes:
measure: Chang of vital parameters (blood pressure) during observation time combined with ADM level.
timeFrame: admission - 5th day (change in the baseline)
measure: Chang of vital parameters (heart rate) during observation time combined with ADM level.
timeFrame: admission - 5th day (change in the baseline)
Locations:
city: Oberwart
country: Austria
facility: KRAGES - Hospital of Oberwart
state: Burgenland
city: Pécs
country: Hungary
facility: University Hospital of Pécs
state: Baranya
Study officials:
affiliation: University of Pécs - School of Medicine
name: Lajos Bogár, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Nishikimi 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.
citation: Geven 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.