Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Amount of exhaled pulmonary embolism-specific proteins
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, the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath, and several of these were also found in a first in-human clinical study what the investigators performed in 2019-2020 (DOI 10.1088/1752-7163/ad0aaa). These biomarkers need consolidation in a clinical setting using an updated collection device and proteomic analysis platform before development of a prototype and further test of this new diagnostic method.
详细描述
The study will compare the protein profiles of exhaled breath from patients admitted to the Emergency Care Center with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender. The main-outcome (i.e., means of the relative amounts of specific proteins in the exhaled breath samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups (PE patients and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of exhaled breath samples from the patients and controls will be compared with results from the porcine model and the first clinical study 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 exhaled breath markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the exhaled breath 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Amount of exhaled pulmonary embolism-specific proteins
时间窗: 1-2 years
The primary outcome is diagnosis of pulmonary embolism by use of one or more novel protein biomarkers in the exhaled breath. The investigators will use semiquantitative analysis to identify the most suitable bomarkers already published: DOI: 10.3390/jcm10215165
次要结局
未报告次要终点
研究者
Inger Lise Gade
Principal Investigator, Registrar, MD, PhD
Aalborg University Hospital
