Adrenomedullin in Context With Pulmonary Embolism

May 10, 2023 updated by: University of Pecs

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Burgenland
      • Oberwart, Burgenland, Austria, 7400
        • KRAGES - Hospital of Oberwart
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • University Hospital of Pecs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • emergency ward
  • cardial observation ward
  • internal medicine ward
  • intensive care ward

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
admission - 5th day (change in the baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion (2 year)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
admission - 5th day (change in the baseline)
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)
admission - 5th day (change in the baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Study Chair: Lajos Bogár, MD, University of Pécs - School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTE/8424-2/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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