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Enrolling by invitation NCT05727852

Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

— Observational Chronic Respiratory Diseases Cystic Fibrosis Lymphangioleiomyomatosis Hypersensitivity Pneumonitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breath test using the Compact PTR-TOF-MS, Portable cardiac monitor "CardioQvark", Assessment of arterial stiffness using the VaSera VS-1500N.
Who it may be relevant to
Registry conditions: Chronic Respiratory Diseases, Cystic Fibrosis, Lymphangioleiomyomatosis, Hypersensitivity Pneumonitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • 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).
  • Diagnostic test 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.
  • Diagnostic test 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.

Primary outcome measures

  • Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria) [Time frame: up to 3 years]
  • Results of recording an electrocardiogram (ECG) in one lead with an assessment of the pulse wave [Time frame: up to 3 years]
  • Indicators of arterial stiffness [Time frame: up to 3 years]
Secondary outcome measures (1)
  • Composite of clinical records [Time frame: up to 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

Russia · 1 center
  • I.M. Sechenov First Moscow State Medical University (Sechenov University), Center "Digital — Moscow

Identifiers

NCT: NCT05727852 · RD-comPV- EMP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗