An observational study in Chronic Respiratory Diseases, Cystic Fibrosis and Lymphangioleiomyomatosis, sponsored by I.M. Sechenov First Moscow State Medical University. Enrolling by invitation at 1 site in Russian Federation. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by I.M. Sechenov First Moscow State Medical University · Observational
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.
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.
The study population consists of all males and females over 18 years old in the community according to inclusion, non-inclusion, and exclusion criteria.
Exclusion Criteria:
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.
Diagnostic Test: Breath test using the Compact PTR-TOF-MS · Diagnostic Test: Portable cardiac monitor "CardioQvark" · Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N
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.
Diagnostic Test: Breath test using the Compact PTR-TOF-MS · Diagnostic Test: Portable cardiac monitor "CardioQvark" · Diagnostic Test: Assessment of arterial stiffness using the VaSera VS-1500N
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).
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 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.
Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria)
Exhaled volatile organic compounds (eVOCs) profiles listed as ions at various mass-to-charge ratios (m/z)
Time frame: up to 3 years
Results of recording an electrocardiogram (ECG) in one lead with an assessment of the pulse wave
Pulse wave velocity, augmentation index, pulse wave type (A, B or C) analysed by a portable cardiac monitor "CardioQvark"
Time frame: up to 3 years
Indicators of arterial stiffness
Cardio-ankle vascular index and ankle-brachial index analysed with using the VaSera VS-1500N
Time frame: up to 3 years
Composite of clinical records
Clinical data are assessed via questionaire according to the Modified Medical Research Council (mMRC) Dyspnea Scale (scale points: 0 scores - the best outcome, 4 scores - the worst outcome) and Borg Dyspnea scale (scale points: 1 score - the best outcome, 10 scores - thr worst outcome), Standard examination of respiratory function (spirometry: FVC, FEV1, FEV1/FVC, FEF75 - % of predicted, absolute value, z-score; body plethysmography: TLC, RV, VC - % of predicted, absolute value, z-score; diffusion test: DLCO, DLCO/VA - % of predicted, absolute value, z-score), echocardiography, CT scan of the chest, if necessary, sputum culture results
Time frame: up to 3 years
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I.M. Sechenov First Moscow State Medical University