NCT07476274 Nosocomial Pneumonia After Coronary Artery Bypass Grafting
| NCT ID | NCT07476274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-10-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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: * 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).
Contact & Investigator
Alla A. Boshchenko, MD, PhD
PRINCIPAL INVESTIGATOR
Cardiology Research Institute of Tomsk NRMC
Frequently Asked Questions
Who can join the NCT07476274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07476274 currently recruiting?
Yes, NCT07476274 is actively recruiting participants. Contact the research team at trs@cardio-tomsk.ru for enrollment information.
Where is the NCT07476274 trial being conducted?
This trial is being conducted at Tomsk, Russia.
Who is sponsoring the NCT07476274 clinical trial?
NCT07476274 is sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. The principal investigator is Alla A. Boshchenko, MD, PhD at Cardiology Research Institute of Tomsk NRMC. The trial plans to enroll 80 participants.