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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05727852
Other study ID # RD-comPV- EMP
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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