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Adrenomedullin in Context With Pulmonary Embolism

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04875130
Enrollment
24
Registered
2021-05-06
Start date
2020-08-19
Completion date
2023-05-08
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism, Adrenomedullin, Biomarker

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).

Interventions

DIAGNOSTIC_TESTblood samples

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

Sponsors

University of Pecs
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Other

MeasureTime frameDescription
Chang of vital parameters (blood pressure) during observation time combined with ADM level.admission - 5th day (change in the baseline)Additionally, the change of vital parameters: * blood pressure (mmHg) * Mean-Arterial-Pressure (MAP - calculated)
Chang of vital parameters (heart rate) during observation time combined with ADM level.admission - 5th day (change in the baseline)Additionally, the change of vital parameters: \- pulse (x/min)

Countries

Austria, Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026