Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

February 6, 2023 updated by: I.M. Sechenov First Moscow State Medical University

Exhaled Breath Proton Mass Spectrometry and Assessment of Endothelial Dysfunction 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

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

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • I.M. Sechenov First Moscow State Medical University (Sechenov University), Center "Digital biodesign and personalized healthcare"

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 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: 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.
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: 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.
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 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.
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria)
Time Frame: up to 3 years
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
Time Frame: up to 3 years
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
Time Frame: up to 3 years
Cardio-ankle vascular index and ankle-brachial index analysed with using the VaSera VS-1500N
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of clinical records
Time Frame: up to 3 years
Clinical data are assessed via questionaire according to the Modified Medical Research Council (mMRC) Dyspnea Scale, Borg Dyspnea scale, standard examination of respiratory function (spirometry, body plethysmography, diffusion test), echocardiography, CT scan of the chest, if necessary, sputum culture results
up to 3 years

Collaborators and Investigators

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

Sponsor

I.M. Sechenov First Moscow State Medical University

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 Major Dates

Study Start (ACTUAL)

January 30, 2023

Primary Completion (ANTICIPATED)

January 1, 2025

Study Completion (ANTICIPATED)

December 1, 2026

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (ESTIMATE)

February 14, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD-comPV- EMP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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