Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875130
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2021-04-27
Brief Title:
Adrenomedullin in Context With Pulmonary Embolism
Sponsor:
University of Pecs
Organization:
University of Pecs
Study Overview
Official Title:
Adrenomedullin in Context With the Diagnose of Pulmonary Embolism and Its Positive Negative Predictive Value
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 its 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 wasnt 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 measureanalyse 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
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 wasnt 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 measureanalyse 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None