Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Detection of volatile organic compounds in breath samples
研究概览
简要总结
Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples.
Breath testing, which links specific volatile molecular biomarkers in exhaled breath to medical conditions, is becoming increasingly popular as a non-invasive and potentially inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from exhaled breath, thus producing a distinct fingerprint for each mixture of analytes.
Several studies have been published, stating the advantages of these sensors, leading to promising outcomes in several fields.
The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10 min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free of any side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •signed informed consent
- •≥ 18 years of age, male or female
- •Left ventricular Ejection fraction less than 40% or known to suffer from heart failure with preserved ejection fraction
- •In decompensated heart failure group: dyspnea with confirmation of pulmonary congestion/edema by chest x-ray
排除标准
- •Pericardial diseases, e.g. constrictive pericarditis, tamponade
- •Significant congenital heart disease, up to the investigator's opinion
- •Life-threatening or uncontrolled arrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 beats per minute.
- •Acute ST elevation myocardial infarction
- •Pregnant women
- •Patients with pulmonary embolism
- •Probable alternative diagnoses that in the opinion of the investigator could account for patient's HF symptoms (i.e., dyspnea), such as:
- •significant pulmonary disease
- •anemia with hemoglobin <10 g/dl
- •participation in another study
结局指标
主要结局
Detection of volatile organic compounds in breath samples
时间窗: Each participant's breath sample will be analysed within one week of collection.
Exhaled breath samples will be collected from each volunteer for characterization and identification using two different methods. The first method uses gas chromatography linked to mass spectrometry to identify and quantify the various breath volatile organic compunds (VOC's) in each group studied (compensated heart failure, decompensated heart failure and healthy subjects). The second method deploys cross-reactive nanoarrays in combination with pattern recognition methods (NaNose Technology).
次要结局
未报告次要终点
研究者
Manhal Habib MD, PhD
Principal investigator
Rambam Health Care Campus