Nosocomial Pneumonia After Coronary Artery Bypass Grafting

NCT07476274 | Recruiting

• 1 other identifier: CRI-274
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Pneumonia Nosocomial

Keywords

pneumonia; Coronary Artery Bypass Grafting; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (9)

• Levels of procalcitonin (ng/ml);

  12 months

• Levels of interleukins 1 (pg/ml);

  12 months

• Changes in immune status (in percent);

  30 days

• Level of endothelin-1 (ET-1) (pg/ml);

  6 months

• Level of presepsin (pg/ml);

  6 months

Other Outcomes (48)

• Systolic blood pressure (SBP) levels (mmHg);

  12 months

• Level of NT-proBNP (N-terminal pro-B-type natriuretic peptide) (pg/ml);

  6 months

• Presence of life-threatening and symptomatic cardiac arrhythmias (in percent);

  12 months

Study Arms (2)

Main group with HAP after CABG

Patients with coronary artery disease (CAD) after Coronary Artery Bypass Grafting (CABG), complicated by postoperative nosocomial pneumonia.

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.

Other: Clinical, laboratory, and instrumental examination

Interventions

Clinical, laboratory, and instrumental examination OTHER

Clinical, laboratory, and instrumental examinations will be performed to achieve the specified primary and secondary endpoints.

Control group without HAP after CABG; Main group with HAP after CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Diagnosis of malignant neoplasms within the last 5 years.
• Life duration of less than 1 year.
• HIV infection.
• Ventilator-Associated Pneumonia (VAP).
• 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).

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute of Tomsk NRMC

Tomsk, Tomsk Oblast, 634012, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine speciments.

MeSH Terms

Conditions

Coronary Artery Disease; Healthcare-Associated Pneumonia; Pneumonia

Interventions

Laboratories

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Alla A. Boshchenko, MD, PhD

  Cardiology Research Institute of Tomsk NRMC

  PRINCIPAL INVESTIGATOR

• Tatiana P Kalashnikova, MD, PhD

  Cardiology Research Institute of Tomsk NRMC

  STUDY CHAIR

• Irina V. Kologrivova, MD, PhD

  Cardiology Research Institute of Tomsk NRMC

  STUDY CHAIR

• Natalia V. Rebrova, MD, PhD

  Cardiology Research Institute of Tomsk NRMC

  STUDY CHAIR

• Arina S Zinovieva, MD

  Cardiology Research Institute of Tomsk NRMC

  STUDY CHAIR

• Ulia A Arseneva, MD

  Cardiology Research Institute of Tomsk NRMC

  STUDY CHAIR

Central Study Contacts

Roman S. Timoshenko, MD

CONTACT

+79539244630; trs@cardio-tomsk.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 17, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)