Coronary Artery DiseaseCABG-PNEUMNCT07476274
Nosocomial Pneumonia After Coronary Artery Bypass Grafting
An observational study of Coronary Artery Disease and Pneumonia Nosocomial, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
Observational studies of patients with coronary artery bypass grafting, associated with an unfavorable cardiopulmonary prognosis for at least one year after surgery. This is Prospective, cohort, unblinded, observational comparable single center clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Pneumonia Nosocomial
- What is being tested?
- Clinical, laboratory, and instrumental examination
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient enrollment will take place at the Department of Atherosclerosis and Chronic Ischemic Heart Disease and the Department of Cardiovascular Surgery of the Cardiology Research Institute, Tomsk National Research Medical Center of the Russian Academy of Sciences (Cardiology Research Institute, Tomsk NRMC).
Who may be able to join
- Age 18 years and older.
- Myocardial revascularization for CAD via CABG during the current hospitalization, in accordance with the indications defined by the ESC/EACTS Guidelines on Myocardial Revascularization [DOI: 10.1093/eurheartj/ehy394].
- Successful transfer from the intensive care unit to a general ward after surgery.
- One or more of the risk factor for nosocomial pneumonia [doi: 10.15829/1560-4071-2024-6094].
- Signed informed consent for participation in the study.
- Pre-operative Exclusion Criteria:
Show all 28Show fewer
- Acute coronary syndrome within the last 1 month.
- Combined surgical intervention for infective endocarditis.
- Combined valve surgery.
- Concomitant pulmonary disease requiring respiratory support prior to surgery.
- Presence of a tracheostomy.
- Participation in another clinical trial at the time of potential inclusion or within the preceding 3 months.
- Diagnosis of malignant neoplasms within the last 5 years.
- Life duration of less than 1 year.
- HIV infection.
- Peri-operative Exclusion Criteria:
- Ventilator-Associated Pneumonia (VAP).
- Acute Myocardial Infarction after CABG and before inclusion.
- Acute Stroke after CABG and before inclusion.
- Pulmonary after CABG and before inclusion.
- Pulmonary Edema after CABG and before inclusion.
- Acute Respiratory Distress Syndrome (ARDS) after CABG and before inclusion.
- Pneumothorax requiring drainage after CABG and before inclusion.
- Delirium after CABG and before inclusion.
- Chronic Kidney Disease (CKD) Stage 4-5 / Acute Kidney Injury requiring renal replacement therapy or chronic dialysis.
- Any perioperative complication requiring the patient's return to the intensive care unit or prolonging the ICU stay beyond 48 hours.
- Any other active infectious process at a different site.
- Novel Coronavirus Infection (COVID-19).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Cardiology Research Institute of Tomsk NRMC
Tomsk, Tomsk Oblast, 634012
Roman S. Timoshenko, MD, +79539244630, trs@cardio-tomsk.ru
About this study
Official title: The Impact of Nosocomial Pneumonia on the Outcome and Prognosis of Stable Coronary Artery Disease After Coronary Artery Bypass Grafting
Observational studies of patients with coronary artery bypass grafting, associated with an unfavorable cardiopulmonary prognosis for at least one year after surgery.
This is Prospective, cohort, unblinded, observational comparable single center clinical trial. To compare the clinical, laboratory (including complete blood count, metabolic panel, and specific cardiac, inflammatory, infectious, and endothelial biomarkers), functional (ECG, echocardiography, ultrasound, spirometry, cardiopulmonary exercise testing), and radiological (chest X-ray/CT) phenotypes in patients with coronary artery bypass grafting with and without non-ventilator-associated postoperative, nosocomial pneumonia; to identify the factors of early and 1-years cardiopulmonary prognosis.
Read more
Increased risk of cardiovascular outcomes is related with the circulatory arrest, artificial circulation, perioperative trauma and respiratory complications of the postoperative period associating to the different severity and duration of the systemic inflammatory response, immune status disorders, hemostasis disorder, endothelial dysfunction, external respiration dysfunction, anatomic and functional disorders in the heart and lungs. Individual predictors of an unfavorable prognosis can be determined at the stage of before and just after surgery to conduct personalized prevention.
This study aimed to compare the clinical, laboratory (including complete blood count, metabolic panel, and specific cardiac, inflammatory, infectious, and endothelial biomarkers), functional (ECG, echocardiography, ultrasound, spirometry, cardiopulmonary exercise testing), and radiological (chest X-ray/CT) phenotypes in patients after coronary artery bypass grafting with and without non-ventilator-associated postoperative nosocomial pneumonia; to identify the factors of early and 1-years cardiopulmonary prognosis.
Read the detailed description
RESEARCH RELEVANCE Cardiovascular diseases (CVD), remain the leading cause of death worldwide. In 2017, mortality from cardiovascular diseases reached 862,895 people, or 587.6 per 100,000 of the population. Coronary artery disease (CAD) holds the leading position in the structure of causes of death from CVD. The annual mortality rate from CAD is 27%, with 42% of all deceased being of working age. Myocardial revascularization is one of the most common surgical procedures for the effective treatment of CAD. In the United States, over 200,000 coronary artery bypass grafting (CABG) surgeries are performed annually, with approximately 14% of patients being rehospitalized within 30 days after discharge and another 10% visiting emergency departments due to surgery-related complications and care issues. Pulmonary complications, primarily pneumonia (3%-42%), account for a significant proportion of the complications. Although pneumonia primarily affects the lungs, growing evidence suggests that it can have a negative impact on many systems and organs, particularly the cardiovascular system. The impact of pneumonia on the starting CVD consist the most evidences. The short-term and long-term impact of nosocomial pneumonia (NP) on the course of determined CVD, especially following myocardial revascularization performed using coronary bypass grafting (CABG) has not been previously assessed, and potential mechanisms have not been studied. It is known that the CABG leads to an enhanced systemic inflammatory response, is associated with nitric oxide deficiency, endothelial dysfunction, and procoagulant activity. Therefore, a postoperative complication in the form of NP in patients with multivessel CAD and not rare anatomic and functional myocardial disorders could potentially lead to a short-term additive enhancement of the inflammatory and endothelial response associated with the surgery, and to long-term activation of immune inflammation after CABG. The consequence of this may be an increased frequency of any complications within one year or more after surgery and a reduction in its effectiveness in reversing signs of coronary and heart failure. However, there is no confirmation of this assumption. The impact of pneumonia complications, such as respiratory failure, on the course of stable CAD is also insufficiently studied.
The study will be conducted at the Cardiology Research Institute - a branch of the Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences" (Cardiology Research Institute of the Tomsk NRMC) in Tomsk, Russia, from December 2024 to June 2027. The study was approved by the Biomedical Ethics Committee of the Cardiology Research Institute of the Tomsk NRMC on December 25, 2024. Informed consent will be obtained from all study participants after the nature, purpose, and potential risks of the study have been explained to them.
PRIMARY OBJECTIVE To test the hypothesis that in patients with stable coronary artery disease undergoing CABG, the occurrence of postoperative nosocomial pneumonia is associated with an adverse cardiopulmonary prognosis for at least one year after surgery.
SRCONDARY OBJECTIVES To compare the clinical, cellular, secretory, and instrumental profiles, as well as their in-hospital dynamics, between patients with an uncomplicated postoperative course and those complicated by nosocomial pneumonia.
To assess the sensitivity, specificity, and diagnostic accuracy of pulmonary and systemic criteria for diagnosing nosocomial pneumonia in patients with CAD following surgical myocardial revascularization; to identify the most specific systemic diagnostic criteria or propose new ones.
In a prospective one-year follow-up study of patients with CAD corrected by CABG, to evaluate the impact of nosocomial pneumonia on cardiopulmonary prognosis; to identify in-hospital predictors of an unfavorable prognosis for the purpose of personalized prevention.
The effectiveness of the study will be assessed by such a concept as "end point".
The primary endpoint was assessed at visits 5, 6, and 7 as the difference in parameters between the groups with pneumonia and without pneumonia and included the frequency of occurrence of one or more cardiovascular and/or respiratory endpoint events.
- Conditions
- Coronary Artery Disease, Pneumonia Nosocomial
- Being tested
- Clinical, laboratory, and instrumental examination
- Keywords
- pneumonia, Coronary Artery Bypass Grafting, coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Healthcare-Associated Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, laboratory, and instrumental examinationOther
Clinical, laboratory, and instrumental examinations will be performed to achieve the specified primary and secondary endpoints.
| Study group | Role | What they receive |
|---|---|---|
| Main group with HAP after CABG | Patients with coronary artery disease (CAD) after Coronary Artery Bypass Grafting (CABG), complicated by postoperative nosocomial pneumonia. Receives: Other: Clinical, laboratory, and instrumental examination | |
| Control group without HAP after CABG | Patients with coronary artery disease (CAD) after Coronary Artery Bypass Grafting (CABG), without postoperative nosocomial pneumonia. Receives: Other: Clinical, laboratory, and instrumental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of combined cardiovascular+respiratory endpoint (percentage);
The study will assess the incidence (percentage) of occurrence of combined cardiovascular+respiratory endpoint that includes the following events:
- Cardiovascular events: All-cause mortality, cardiovascular mortality, acute myocardial infarction, unstable angina, myocardial revascularization, acute cerebrovascular accident, transient ischemic attack, hospitalization or emergency medical service visit for acute heart failure or decompensation of chronic heart failure, hospitalization for cardiac arrhythmias, new-onset atrial fibrillation.
- Respiratory events: Respiratory mortality, hospitalization for broncho-obstructive or broncho-restrictive diseases, new oxygen dependence, initiation of non-invasive or invasive mechanical ventilation, new diagnosis of bronchial asthma or chronic obstructive pulmonary disease n the frequency of occurrence of one or more cardiovascular and/or respiratory endpoint events.
Measured: 12 months
Secondary outcomes (9)
Levels of procalcitonin (ng/ml);
Difference between groups in the levels of procalcitonin;
Measured: 12 months
Levels of interleukins 1 (pg/ml);
Difference between groups in the levels of interleukins 1.
Measured: 12 months
Changes in immune status (in percent);
Difference between groups in the changes in immune status;
Measured: 30 days
Level of endothelin-1 (ET-1) (pg/ml);
Difference between groups in the level of endothelin-1 (ET-1);
Measured: 6 months
Level of presepsin (pg/ml);
Difference between groups in the levels of presepsin
Measured: 6 months
Interleukins 6(pg/ml);
Difference between groups in the levels of interleukins 6;
Measured: 6 months
Tumor Necrosis Factor α (TNF-α)(pg/ml);
Difference between groups in the levels of TNF-α;
Measured: 6 months
Level of vascular endothelial growth factor (VEGF) (pg/ml);
Difference between groups in the level of vascular endothelial growth factor (VEGF);
Measured: 6 months
Difference between groups in the level of endocan (pg/ml);
Level of endocan .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alla A. Boshchenko, MD, PhD, Principal investigator, Cardiology Research Institute of Tomsk NRMCTatiana P Kalashnikova, MD, PhD, Study chair, Cardiology Research Institute of Tomsk NRMCIrina V. Kologrivova, MD, PhD, Study chair, Cardiology Research Institute of Tomsk NRMCNatalia V. Rebrova, MD, PhD, Study chair, Cardiology Research Institute of Tomsk NRMCArina S Zinovieva, MD, Study chair, Cardiology Research Institute of Tomsk NRMCUlia A Arseneva, MD, Study chair, Cardiology Research Institute of Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476274
- Sponsor's protocol ID
- CRI-274
- Acronym
- CABG-PNEUM
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nosocomial Pneumonia on the Outcome and Prognosis of Stable Coronary Artery Disease After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07476274
- Acronym / sponsor ID
- CABG-PNEUM / CRI-274
- Conditions
- Coronary Artery Disease, Pneumonia Nosocomial
- Keywords
- pneumonia, Coronary Artery Bypass Grafting, coronary artery disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational studies of patients with coronary artery bypass grafting, associated with an unfavorable cardiopulmonary prognosis for at least one year after surgery.
This is Prospective, cohort, unblinded, observational comparable single center clinical trial. To compare the clinical, laboratory (including complete blood count, metabolic panel, and specific cardiac, inflammatory, infectious, and endothelial biomarkers), functional (ECG, echocardiography, ultrasound, spirometry, cardiopulmonary exercise testing), and radiological (chest X-ray/CT) phenotypes in patients with coronary artery bypass grafting with and without non-ventilator-associated postoperative, nosocomial pneumonia; to identify the factors of early and 1-years cardiopulmonary prognosis.
Increased risk of cardiovascular outcomes is related with the circulatory arrest, artificial circulation, perioperative trauma and respiratory complications of the postoperative period associating to the different severity and duration of the systemic inflammatory response, immune status disorders, hemostasis disorder, endothelial dysfunction, external respiration dysfunction, anatomic and functional disorders in the heart and lungs. Individual predictors of an unfavorable prognosis can be determined at the stage of before and just after surgery to conduct personalized prevention.
This study aimed to compare the clinical, laboratory (including complete blood count, metabolic panel, and specific cardiac, inflammatory, infectious, and endothelial biomarkers), functional (ECG, echocardiography, ultrasound, spirometry, cardiopulmonary exercise testing), and radiological (chest X-ray/CT) phenotypes in patients after coronary artery bypass grafting with and without non-ventilator-associated postoperative nosocomial pneumonia; to identify the factors of early and 1-years cardiopulmonary prognosis.
Detailed description
RESEARCH RELEVANCE Cardiovascular diseases (CVD), remain the leading cause of death worldwide. In 2017, mortality from cardiovascular diseases reached 862,895 people, or 587.6 per 100,000 of the population. Coronary artery disease (CAD) holds the leading position in the structure of causes of death from CVD. The annual mortality rate from CAD is 27%, with 42% of all deceased being of working age. Myocardial revascularization is one of the most common surgical procedures for the effective treatment of CAD. In the United States, over 200,000 coronary artery bypass grafting (CABG) surgeries are performed annually, with approximately 14% of patients being rehospitalized within 30 days after discharge and another 10% visiting emergency departments due to surgery-related complications and care issues. Pulmonary complications, primarily pneumonia (3%-42%), account for a significant proportion of the complications. Although pneumonia primarily affects the lungs, growing evidence suggests that it can have a negative impact on many systems and organs, particularly the cardiovascular system. The impact of pneumonia on the starting CVD consist the most evidences. The short-term and long-term impact of nosocomial pneumonia (NP) on the course of determined CVD, especially following myocardial revascularization performed using coronary bypass grafting (CABG) has not been previously assessed, and potential mechanisms have not been studied. It is known that the CABG leads to an enhanced systemic inflammatory response, is associated with nitric oxide deficiency, endothelial dysfunction, and procoagulant activity. Therefore, a postoperative complication in the form of NP in patients with multivessel CAD and not rare anatomic and functional myocardial disorders could potentially lead to a short-term additive enhancement of the inflammatory and endothelial response associated with the surgery, and to long-term activation of immune inflammation after CABG. The consequence of this may be an increased frequency of any complications within one year or more after surgery and a reduction in its effectiveness in reversing signs of coronary and heart failure. However, there is no confirmation of this assumption. The impact of pneumonia complications, such as respiratory failure, on the course of stable CAD is also insufficiently studied.
The study will be conducted at the Cardiology Research Institute - a branch of the Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences" (Cardiology Research Institute of the Tomsk NRMC) in Tomsk, Russia, from December 2024 to June 2027. The study was approved by the Biomedical Ethics Committee of the Cardiology Research Institute of the Tomsk NRMC on December 25, 2024. Informed consent will be obtained from all study participants after the nature, purpose, and potential risks of the study have been explained to them.
PRIMARY OBJECTIVE To test the hypothesis that in patients with stable coronary artery disease undergoing CABG, the occurrence of postoperative nosocomial pneumonia is associated with an adverse cardiopulmonary prognosis for at least one year after surgery.
SRCONDARY OBJECTIVES To compare the clinical, cellular, secretory, and instrumental profiles, as well as their in-hospital dynamics, between patients with an uncomplicated postoperative course and those complicated by nosocomial pneumonia.
To assess the sensitivity, specificity, and diagnostic accuracy of pulmonary and systemic criteria for diagnosing nosocomial pneumonia in patients with CAD following surgical myocardial revascularization; to identify the most specific systemic diagnostic criteria or propose new ones.
In a prospective one-year follow-up study of patients with CAD corrected by CABG, to evaluate the impact of nosocomial pneumonia on cardiopulmonary prognosis; to identify in-hospital predictors of an unfavorable prognosis for the purpose of personalized prevention.
The effectiveness of the study will be assessed by such a concept as "end point".
The primary endpoint was assessed at visits 5, 6, and 7 as the difference in parameters between the groups with pneumonia and without pneumonia and included the frequency of occurrence of one or more cardiovascular and/or respiratory endpoint events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main group with HAP after CABG | – | Other: Clinical, laboratory, and instrumental examinationPatients with coronary artery disease (CAD) after Coronary Artery Bypass Grafting (CABG), complicated by postoperative nosocomial pneumonia. |
| Control group without HAP after CABG | – | Other: Clinical, laboratory, and instrumental examinationPatients with coronary artery disease (CAD) after Coronary Artery Bypass Grafting (CABG), without postoperative nosocomial pneumonia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient enrollment will take place at the Department of Atherosclerosis and Chronic Ischemic Heart Disease and the Department of Cardiovascular Surgery of the Cardiology Research Institute, Tomsk National Research Medical Center of the Russian Academy of Sciences (Cardiology Research Institute, Tomsk NRMC).
Key inclusion criteria (28 listed)
- Age 18 years and older.
- Myocardial revascularization for CAD via CABG during the current hospitalization, in accordance with the indications defined by the ESC/EACTS Guidelines on Myocardial Revascularization [DOI: 10.1093/eurheartj/ehy394].
- Successful transfer from the intensive care unit to a general ward after surgery.
- One or more of the risk factor for nosocomial pneumonia [doi: 10.15829/1560-4071-2024-6094].
- Signed informed consent for participation in the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical, laboratory, and instrumental examinationClinical, laboratory, and instrumental examinations will be performed to achieve the specified primary and secondary endpoints. | Other | Control group without HAP after CABG, Main group with HAP after CABG |
Primary outcome
Incidence of combined cardiovascular+respiratory endpoint (percentage);
Time frame: 12 months
The study will assess the incidence (percentage) of occurrence of combined cardiovascular+respiratory endpoint that includes the following events: * Cardiovascular events: All-cause mortality, cardiovascular mortality, acute myocardial infarction, unstable angina, myocardial revascularization, acute cerebrovascular accident, transient ischemic attack, hospitalization or emergency medical service visit for acute heart failure or decompensation of chronic heart failure, hospitalization for cardiac arrhythmias, new-onset atrial fibrillation. * Respiratory events: Respiratory mortality, hospitalization for broncho-obstructive or broncho-restrictive diseases, new oxygen dependence, initiation of non-invasive or invasive mechanical ventilation, new diagnosis of bronchial asthma or chronic obstructive pulmonary disease n the frequency of occurrence of one or more cardiovascular and/or respiratory endpoint events.
9 secondary outcomes
Levels of procalcitonin (ng/ml);
Time frame: 12 months
Levels of interleukins 1 (pg/ml);
Time frame: 12 months
Changes in immune status (in percent);
Time frame: 30 days
Level of endothelin-1 (ET-1) (pg/ml);
Time frame: 6 months
Level of presepsin (pg/ml);
Time frame: 6 months
Interleukins 6(pg/ml);
Time frame: 6 months
Tumor Necrosis Factor α (TNF-α)(pg/ml);
Time frame: 6 months
Level of vascular endothelial growth factor (VEGF) (pg/ml);
Time frame: 6 months
Difference between groups in the level of endocan (pg/ml);
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alla A. Boshchenko, MD, PhD principal investigator
Cardiology Research Institute of Tomsk NRMC
Tatiana P Kalashnikova, MD, PhD study chair
Cardiology Research Institute of Tomsk NRMC
Irina V. Kologrivova, MD, PhD study chair
Cardiology Research Institute of Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Pneumonia Nosocomial, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roman S. Timoshenko, MD (+79539244630, trs@cardio-tomsk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of combined cardiovascular+respiratory endpoint (percentage); (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.