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Enrolling by Invitation

NCT Number: NCT05727852

Breath Analysis and Arterial Stiffness 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.

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Key information

Conditions

Chronic Respiratory Diseases Alveolitis, Extrinsic Allergic Asthma Bronchial Asthma Bronchial Diseases COPD Cardiovascular Diseases Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disease Attributes Genetic Diseases, Inborn Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity Pneumonitis Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Infant, Newborn, Diseases Interstitial Lung Diseases Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Lymphangioleiomyomatosis Lymphangiomyoma Lymphatic Diseases Lymphoproliferative Disorders Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perivascular Epithelioid Cell Neoplasms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, 119991, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. 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)

  2. 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"

  3. 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

Secondary outcomes

  1. 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 (scale points: 0 scores - the best outcome, 4 scores - the worst outcome) and Borg Dyspnea scale (scale points: 1 score - the best outcome, 10 scores - thr worst outcome), Standard examination of respiratory function (spirometry: FVC, FEV1, FEV1/FVC, FEF75 - % of predicted, absolute value, z-score; body plethysmography: TLC, RV, VC - % of predicted, absolute value, z-score; diffusion test: DLCO, DLCO/VA - % of predicted, absolute value, z-score), echocardiography, CT scan of the chest, if necessary, sputum culture results

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 14, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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