跳至主要内容
临床试验/NCT04010760
NCT04010760已完成不适用

Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年4月8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
110
试验地点
1
主要终点
Prediction of pulmonary embolism by use of biomarkers in the EBC

研究概览

简要总结

In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested. In pre-clinical studies, we have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath condensate (EBC). These biomarkers needs validation/consolidation in a clinical setting before further test of this new diagnostic method.

详细描述

The study will compare the protein profiles of EBC collected from patients admitted to the department of cardiology with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender from the outpatient clinic awaiting elective cardiovascular surgery. The main-outcome (i.e. means of the relative amounts of specific proteins in the EBC samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the three groups (PE confirmed, PE suspected but not confirmed and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of EBC samples from the patients and controls will be compared with results from the porcine model in order to confirm and reduce the number of putative biomarkers for PE. Blood samples (i.e. excess plasma from routine blood samples drawn as a part of routine diagnostic work-up) from the study participants will be stored for standardization of the putative markers and verification and supplementing analysis of the EBC markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the EBC samples must be completed before the blood samples can be analyzed. Only biochemical, no genetic analysis will be conducted.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • Active malignant disease (i.e. ongoing anti-cancer therapy or palliation).
  • Current smokers

结局指标

主要结局

Prediction of pulmonary embolism by use of biomarkers in the EBC

时间窗: 1-2 years

The primary outcome is prediction of pulmonary embolism by use of one or more novel biomarkers in the EBC.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Inger Lise Gade

MD, PhD, Registrar

Aalborg University Hospital

研究点 (1)

Loading locations...

相似试验