Clinical trial NCT05727852: Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases
Official title: Exhaled Breath Proton Mass Spectrometry and Assessment of Endothelial Dysfunction in Patients With Respiratory Diseases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Respiratory Diseases
Cystic Fibrosis
Lymphangioleiomyomatosis
Hypersensitivity Pneumonitis
Interstitial Lung Diseases
COPD
Bronchial Asthma
Keywords: Proton-transfer reaction mass spectrometry (PTR-TOF-MS)
Exhaled volatile organic compounds (eVOCs)
Endothelial function
Arterial stiffness
Cardiovascular disorders
Ventilation disorders
Gas exchange disorders
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of all males and females over 18 years old in the community according to inclusion, non-inclusion, and exclusion criteria.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria)
timeFrame: up to 3 years
measure: Results of recording an electrocardiogram (ECG) in one lead with an assessment of the pulse wave
timeFrame: up to 3 years
measure: Indicators of arterial stiffness
timeFrame: up to 3 years
Secondary outcomes:
measure: Composite of clinical records
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University (Sechenov University), Center "Digital biodesign and personalized healthcare"
Study officials:
References: