Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

I.M. Sechenov First Moscow State Medical University

Status: Invitation-only

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

Treatments: 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"

Study type: Observational

Funder types: Other

Identifiers

NCT05727852

RD-comPV- EMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

Experimental: patients with chronic respiratory diseases

Description:

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.

Treatment:

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

Active Comparator: Control

Description:

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.

Treatment:

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