Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

Cystic Fibrosis Clinical Trial

Official title:

Exhaled Breath Proton Mass Spectrometry and Assessment of Endothelial Dysfunction in Patients With Respiratory Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05727852
• Other study ID #: RD-comPV- EMP
• Status: Enrolling by invitation
• Start date: January 30, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Asthma
• Bronchial Asthma
• Chronic Respiratory Diseases
• COPD
• Cystic Fibrosis
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial
• Lymphangioleiomyomatosis
• Pneumonia
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

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).
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Indicators of arterial stiffness	Cardio-ankle vascular index and ankle-brachial index analysed with using the VaSera VS-1500N	up to 3 years
Secondary	Composite of clinical records	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