Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases
NCT ID: NCT05727852
Last Updated: 2024-07-30
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
400 participants
OBSERVATIONAL
2023-01-30
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Study Groups
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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.
Breath test using the Compact PTR-TOF-MS
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"
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
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.
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.
Breath test using the Compact PTR-TOF-MS
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"
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
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.
Interventions
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Breath test using the Compact PTR-TOF-MS
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"
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
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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I.M. Sechenov First Moscow State Medical University
OTHER
Responsible Party
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Locations
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I.M. Sechenov First Moscow State Medical University (Sechenov University), Center "Digital biodesign and personalized healthcare"
Moscow, , Russia
Countries
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Other Identifiers
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RD-comPV- EMP
Identifier Type: -
Identifier Source: org_study_id
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