Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

Trial Title: Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

NCT ID: NCT05727852

Condition: Chronic Respiratory Diseases
Cystic Fibrosis
Lymphangioleiomyomatosis
Hypersensitivity Pneumonitis
Interstitial Lung Diseases
COPD
Bronchial Asthma

Conditions: Official terms:
Pneumonia
Lymphangioleiomyomatosis
Cystic Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Respiration Disorders
Asthma
Alveolitis, Extrinsic Allergic
Hypersensitivity

Conditions: 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

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Diagnostic Test
Intervention name: Breath test using the Compact PTR-TOF-MS
Description: Breath samples will be analyzed with a proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria) to obtain eVOCs profiles listed as ions at various mass-to-charge ratios (m/z).
Arm group label: Active Comparator: Control
Arm group label: Experimental: patients with chronic respiratory diseases

Intervention type: Diagnostic Test
Intervention name: Portable cardiac monitor "CardioQvark"
Description: Record an electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark" (Russia, LLC "L Card" , RU No. RZN 2019/8124 dated February 15, 2019) once. Devices automatically transfer data to the A&D Connect app paired with it (link). When transferring data, they are completely protected. The data obtained using the application must be sent to the specialists of the research group in a depersonalized form.
Arm group label: Active Comparator: Control
Arm group label: Experimental: patients with chronic respiratory diseases

Intervention type: Diagnostic Test
Intervention name: Assessment of arterial stiffness using the VaSera VS-1500N
Description: Assessment of arterial stiffness using the VaSera VS-1500N Fukuda Denshi device by non-invasive measurement of blood pressure in four limbs with simultaneous recording of ECG, PCG and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs.
Arm group label: Active Comparator: Control
Arm group label: Experimental: patients with chronic respiratory diseases

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.

Criteria for eligibility:

Study pop:
The study population consists of all males and females over 18 years old in the community according to inclusion, non-inclusion, and exclusion criteria.

Sampling method: Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: I.M. Sechenov First Moscow State Medical University (Sechenov University), Center "Digital biodesign and personalized healthcare"

Address:
City: Moscow
Zip: 119991
Country: Russian Federation

Start date: January 30, 2023

Completion date: December 2026

Lead sponsor:
Agency: I.M. Sechenov First Moscow State Medical University
Agency class: Other

Source: I.M. Sechenov First Moscow State Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05727852