Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

NCT05727852 | Enrolling By Invitation DMC

• 1 other identifier: RD-comPV- EMP
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Proton-transfer reaction mass spectrometry (PTR-TOF-MS); Exhaled volatile organic compounds (eVOCs); Endothelial function; Arterial stiffness; Cardiovascular disorders; Ventilation disorders; Gas exchange disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Composite of clinical records

  up to 3 years

Study Arms (2)

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: 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

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: 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

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).

Active Comparator: Control; Experimental: patients with chronic respiratory diseases

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.

Active Comparator: Control; Experimental: patients with chronic respiratory diseases

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.

Active Comparator: Control; Experimental: patients with chronic respiratory diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Written informed consent to participate in the study;
• Age 18 and over;
• Clinical diagnosis of one of chronic respiratory diseases (COPD, bronchial asthma, cystic fibrosis, lymphangioleiomyomatosis, hypersensitivity pneumonitis or other interstitial lung disease).

You may not qualify if:

• Unable to sign informed consent;
• Respiratory disease (for controls);
• Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
• Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the last 3 months;
• Oncology;
• Previous lung transplantation (for patients with respiratory diseases);
• Diseases and conditions that can change the ECG picture and complicate the analysis of the ECG (conduction disturbance, pacemaker);
• Inability to use a heart monitor (congenital developmental anomalies, traumatic amputation of the upper limbs, essential tremor, Parkinson's disease);
• Pregnancy.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

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

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Cystic Fibrosis; Lymphangioleiomyomatosis; Alveolitis, Extrinsic Allergic; Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive; Asthma; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Lymphangiomyoma; Neoplasm, Lymphatic Tissue; Neoplasms by Histologic Type; Neoplasms; Perivascular Epithelioid Cell Neoplasms; Neoplasms, Connective and Soft Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 14, 2023
• Study Start: January 30, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-03

Locations

RU (1)