Adrenomedullin in Context With Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Adrenomedullin in Context With the Diagnose of Pulmonary Embolism and Its Positive / Negative Predictive Value

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875130
• Other study ID #: PTE/8424-2/2020
• Status: Completed
• Start date: August 19, 2020
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• blood samples
Taking blood samples (plasma, serum) and measure the level of Adrenomedullin

Locations

Country	Name	City	State
Austria	KRAGES - Hospital of Oberwart	Oberwart	Burgenland
Hungary	University Hospital of Pécs	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Countries where clinical trial is conducted

Austria,  Hungary, 

References & Publications (3)

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. — View 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. — View 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/ejh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chang of vital parameters (blood pressure) during observation time combined with ADM level.	Additionally, the change of vital parameters: blood pressure (mmHg); Mean-Arterial-Pressure (MAP - calculated)	admission - 5th day (change in the baseline)
Other	Chang of vital parameters (heart rate) during observation time combined with ADM level.	Additionally, the change of vital parameters: - pulse (x/min)	admission - 5th day (change in the baseline)
Primary	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	admission - 5th day (change in the baseline)
Secondary	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.	through study completion (2 year)

External Links

•   Pulmonary embolism in adults