Adrenomedullin in Context With Pulmonary Embolism

Completed

• Conditions: Pulmonary Embolism
• Interventions: Diagnostic Test: blood samples

• Registration Number: NCT04875130
• Lead Sponsor: University of Pecs

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-19
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-06
• Status Verified: 2023-05
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
confirmed pulmonary embolism	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.

Primary Outcome Measures

Name	Time	Method
Is Adrenomedullin (ADM) a useful new biomarker in the diagnose of pulmonary embolism?	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

Secondary Outcome Measures

Name	Time	Method
Is it possible to quantify the severity of pulmonary embolism, because of knowing the elevation of adrenomedullin in systemic circulation failure?	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.

Trial Locations

Locations (2)

KRAGES - Hospital of Oberwart; 🇦🇹 Oberwart, Burgenland, Austria

University Hospital of Pécs; 🇭🇺 Pécs, Baranya, Hungary