跳至主要内容
临床试验/NCT05727852
NCT05727852Enrolling By Invitation不适用

Exhaled Breath Proton Mass Spectrometry and Assessment of Endothelial Dysfunction in Patients With Respiratory Diseases

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
1
主要终点
Indicators of arterial stiffness

研究概览

简要总结

Assessment of cardiovascular disorders using echocardiography and arterial stiffness; comparative noninvasive assessment of volatile organic compound (eVOC) exhale breath patterns in patients with different chronic respiratory diseases with age and gender-matched healthy adults in order to identify a disease-specific exhaled eVOCs profiles and markers of respiratory and cardiovascular disorders.

详细描述

Evaluating of eVOCs profiles by proton mass spectrometry with a time-of-flight (PTR-TOF) in patients with different chronic respiratory diseases is of great interest for assessing the prognosis and development of severe ventilation and cardiovascular disorders.

The aim of our study is to determine the diagnostic significance of PTR-TOF analysis in patients with chronic respiratory diseases and to identify specific eVOC markers of a severe ventilation and cardiovascular disorders in patients with different chronic respiratory diseases.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

  • Written informed consent to participate in the study;
  • Age 18 and over;
  • Clinical diagnosis of one of chronic respiratory diseases (COPD, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis or other interstitial lung disease).

排除标准

  • Unable to sign informed consent;
  • Respiratory disease (for controls);
  • Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
  • Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the last 3 months;
  • Previous lung transplantation (for patients with respiratory diseases);
  • Diseases and conditions that can change the ECG picture and complicate the analysis of the ECG (conduction disturbance, pacemaker);
  • Inability to use a heart monitor (congenital developmental anomalies, traumatic amputation of the upper limbs, essential tremor, Parkinson's disease);

结局指标

主要结局

Indicators of arterial stiffness

时间窗: up to 3 years

Cardio-ankle vascular index and ankle-brachial index analysed with using the VaSera VS-1500N

Results of recording an electrocardiogram (ECG) in one lead with an assessment of the pulse wave

时间窗: up to 3 years

Pulse wave velocity, augmentation index, pulse wave type (A, B or C) analysed by a portable cardiac monitor "CardioQvark"

Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria)

时间窗: up to 3 years

Exhaled volatile organic compounds (eVOCs) profiles listed as ions at various mass-to-charge ratios (m/z)

次要结局

  • Composite of clinical records(up to 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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