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NCT Number: NCT04875130

Adrenomedullin in Context With Pulmonary Embolism

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KRAGES - Hospital of Oberwart, Oberwart, Burgenland, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood samples

Diagnostic Test

Taking blood samples (plasma, serum) and measure the level of Adrenomedullin

Primary outcomes

  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 (pg/ml) during observation time.

    • 4 samples are taken

Secondary outcomes

  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.

Other outcomes

  1. Chang of vital parameters (blood pressure) during observation time combined with ADM level.

    Time frame: admission - 5th day (change in the baseline)

    Additionally, the change of vital parameters:

    • blood pressure (mmHg)
    • Mean-Arterial-Pressure (MAP - calculated)
  2. Chang of vital parameters (heart rate) during observation time combined with ADM level.

    Time frame: admission - 5th day (change in the baseline)

    Additionally, the change of vital parameters:

    • pulse (x/min)

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 6, 2021
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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