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临床试验/NCT04875130
NCT04875130已完成不适用

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

University of Pecs2 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2020年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Is Adrenomedullin (ADM) a useful new biomarker in the diagnose of pulmonary embolism?

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Is Adrenomedullin (ADM) a useful new biomarker in the diagnose of pulmonary embolism?

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Adrenomedullin in Context With Pulmonary Embolism | 临床试验