Pneumonia After Cardiovascular Surgery With an Artificial Intelligence

NCT07745491 | Recruiting DMC

• 1 other identifier: CRI-253/2
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, prospective, observational study aims to address two primary objectives. The first objective is to demonstrate that hospital-acquired pneumonia (nosocomial pneumonia) following cardiac surgery can be predicted using artificial intelligence (AI), and to develop a personalized risk calculator for its development. The second objective is to demonstrate that hospital-acquired pneumonia can serve as a risk factor for a 1-year composite cardiovascular and pulmonary outcome after cardiac surgery, and to develop a personalized risk calculator for this composite outcome. The composite outcome will include the occurrence of any of the following events:

• Respiratory death
• Hospitalization for respiratory diseases
• Development of oxygen dependence
• New-onset asthma, COPD, or interstitial lung disease
• Initiation or intensification of bronchodilator or corticosteroid therapy
• Cardiovascular death
• Acute myocardial infarction
• Unstable angina
• Myocardial revascularization
• Acute ischemic stroke
• Transient ischemic attack
• Acute heart failure
• Hospitalization for decompensated heart failure
• New-onset atrial fibrillation or ventricular tachycardia
• Initiation or intensification of antiarrhythmic therapy Both objectives will be addressed using artificial intelligence technologies applied during the data analysis phase. This is a non-interventional study. Patient evaluation and treatment are conducted in strict accordance with approved standards of medical care for the respective conditions. No experimental or unregistered (not approved for use in the Russian Federation) medical or diagnostic procedures will be performed during this study.

Conditions

Hospital Acquired Pneumonia

Keywords

Hospital aquired pneumonia; Risk factors; Composite Cardiovascular and Pulmonary outcomes

Outcome Measures

Primary Outcomes (2)

• Hospital acquired pneumonia

  Occurrence of hospital-acquired pneumonia

  Within 30 days post-surgery

• Composite cardiovascular and pulmonary endpoint

  Occurrence of the composite cardiovascular and pulmonary endpoint

  12 months post-surgery

Secondary Outcomes (3)

• Non-pneumonia postoperative complications

  Within 30 days post-surgery

• Composite Pulmonary Outcome

  12 months post-surgery

• Composite Cardiovascular Outcome

  12 months post-surgery

Study Arms (1)

Patients after cardiovascular surgery

Patients of 18 years and older, after cardiac and/or vascular surgical intervention during the current hospitalization, who signed informed consent for the use of their anonymized data for scientific purposes

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

Patients after cardiovascular surgery

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

Patients of 18 years and older after cardiac and/or vascular surgical intervention during the current hospitalization

You may qualify if:

• Age ≥ 18 years;
• Cardiac and/or vascular surgical intervention during the current hospitalization;
• Signed informed consent from the patient for the use of their anonymized data for scientific purposes.

You may not qualify if:

• Use of systemic antibacterial drugs within 30 days prior to the surgical intervention;
• Prescription of systemic antibacterial drugs during the hospitalization period for any indication other than hospital-acquired pneumonia;
• HIV infection.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead
• National Research Tomsk State University: collaborator
• Research Institute for Complex Problems of Cardiovascular Diseases, Russia: collaborator

Study Sites (1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia

Tomsk, Russia

RECRUITING

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alla A. Boshchenko, MD, PhD, DSc

  Cardiology Research Institute of Tomsk NRMC

  STUDY DIRECTOR

• Tatiana P. Kalashnikova, MD, PhD

  Cardiology Research Institute of Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alla A. Boshchenko, MD, PhD, DSc

CONTACT

+ 7 (3822)-909055; bosh@cardio-tomsk.ru

Tatiana P. Kalashnikova, MD, PhD

CONTACT

+7 913 814 1664; kalashnikova-t@mail.ru

Study Design

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

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

RU (1)