Breath Analysis And Arterial Stiffness In Patients With Respiratory Diseases

Study Overview

Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

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.

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

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

RD-comPV- EMP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-02-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-27
First Submitted that Met QC Criteria 2023-02-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-30
First Posted (ACTUAL) 2023-02-14	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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 P	DIAGNOSTIC_TEST: 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). DIAGNOSTIC_TEST: 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 Co DIAGNOSTIC_TEST: 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 arterie
: 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 "CardioQva	DIAGNOSTIC_TEST: 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). DIAGNOSTIC_TEST: 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 Co DIAGNOSTIC_TEST: 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 arterie

Participant Group/Arm

Intervention/Treatment

: 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 P

DIAGNOSTIC_TEST: 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).

DIAGNOSTIC_TEST: 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 Co

DIAGNOSTIC_TEST: 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 arterie

: 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 "CardioQva

DIAGNOSTIC_TEST: 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).

DIAGNOSTIC_TEST: 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 Co

DIAGNOSTIC_TEST: 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 arterie

Primary Outcome Measures	Measure Description	Time Frame
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)	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"	up to 3 years
Indicators of arterial stiffness	Cardio-ankle vascular index and ankle-brachial index analysed with using the VaSera VS-1500N	up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
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	up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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