Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

Sponsor
I.M. Sechenov First Moscow State Medical University
Study ID
NCT05727852
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Breath test using the Compact PTR-TOF-MS — DIAGNOSTIC_TEST
    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).
  • Portable cardiac monitor "CardioQvark" — DIAGNOSTIC_TEST
    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.
  • Assessment of arterial stiffness using the VaSera VS-1500N — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Feb 14, 2023
Start date
Jan 30, 2023
Status verified
Mar 2024
Primary completion
Jan 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Experimental: patients with chronic respiratory diseases
    Included patients, aged ≥ 18 years, with chronic respiratory diseases: COPD, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis and other interstitial lung diseases. Intervention: breath analysis using the Compact PTR-MS proton mass spectrometer by Ionicon (Austria); electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; 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 electrocardiogram (ECG), phonocardiogram (PCG) and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs. Interventions: Diagnostic Test: Breath analysis using the Compact PTR-MS proton mass spectrometer; Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N.
  • Arm: Active Comparator: Control
    Included subjects, aged ≥ 18 years. Intervention: breath analysis using the Compact PTR-MS proton mass spectrometer by Ionicon (Austria); electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; 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, phonocardiogram (PCG) and pulse waves on the carotid, femoral arteries, as well as on the arteries of four limbs. Interventions: Diagnostic Test: Breath analysis using the Compact PTR-MS proton mass spectrometer; Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N.

Primary Outcome Measure

Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria) [ Time Frame: up to 3 years ]

Find similar trials

Nationwide
Asthma trialsCOPD trialsPulmonology trialsLung disease trials

Related Studies