Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases (NCT05727852) | Clinical Trial Compass
By InvitationNot Applicable
Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases
Russia400 participantsStarted 2023-01-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Molecular composition of exhaled breath analysed by proton-transfer reaction mass spectrometer (Compact PTR-MS, Ionicon, Austria)
Timeframe: up to 3 years
2
Results of recording an electrocardiogram (ECG) in one lead with an assessment of the pulse wave
Timeframe: up to 3 years
3
Indicators of arterial stiffness
Timeframe: up to 3 years
Trial details
NCT IDNCT05727852
SponsorI.M. Sechenov First Moscow State Medical University
. 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);