NCT04875130

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

April 27, 2021

Last Update Submit

May 10, 2023

Conditions

Pulmonary Embolism

Keywords

Pulmonary EmbolismAdrenomedullinBiomarker

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Other Outcomes (2)

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

    admission - 5th day (change in the baseline)

  • Chang of vital parameters (heart rate) during observation time combined with ADM level.

    admission - 5th day (change in the baseline)

Study Arms (1)

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

Interventions

blood samplesDIAGNOSTIC_TEST

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

confirmed pulmonary embolism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Age under 18.
  • Missing written agreement or cancelled agreement on any time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KRAGES - Hospital of Oberwart

Oberwart, Burgenland, 7400, Austria

Location

University Hospital of Pécs

Pécs, Baranya, 7624, Hungary

Location

Related Publications (3)

  • 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.

    PMID: 30592365RESULT

  • 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.

    PMID: 29153200RESULT

  • 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.

    PMID: 29520277RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

plasma serum

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Lajos Bogár, MD

    University of Pécs - School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 6, 2021

Study Start

August 19, 2020

Primary Completion

May 8, 2023

Study Completion

May 8, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)HU(1)