Cystic Fibrosis Clinical Trial
Official title:
Exhaled Breath Proton Mass Spectrometry and Assessment of Endothelial Dysfunction in Patients With Respiratory Diseases
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | I.M. Sechenov First Moscow State Medical University (Sechenov University), Center "Digital biodesign and personalized healthcare" | Moscow |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
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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