Short-Term and Long-Term Cognitive Outcomes in Adults After Cardiac Surgery
1 other identifier
observational
250
1 country
1
Brief Summary
Adults with coronary artery disease (250 patients) undergoing cardiac surgery participated in the study. The aim is to investigate short-term and long-term cognitive outcomes and the patterns of organization of functional brain systems in ischemic brain damage using high-resolution electroencephalography, domain-specific assessment of cognitive status and analysis of markers of a neurovascular unit (neuron-specific enolase, brain neurotrophic factor).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2011
CompletedFirst Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 29, 2021
December 1, 2021
10.9 years
November 29, 2021
December 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative cognitive dysfunction
Postoperative cognitive dysfunction (POCD) is a decline in cognitive functions following surgery and anesthesia, characterized by impairment of attention, concentration, and memory that may have long-term implications. The cognitive status assessment includes extended neuropsychological testing (the assessment of psychomotor and executive function, attention, and short-term memory from the neuropsychological test battery of the psychophysiological complex software "Status PF" (Rospatent № 2001610233).
up to 5-7 years after surgery
Secondary Outcomes (3)
Basic cognitive status as measured by the Mini-Mental State Examination (MMSE) scale
up to 5-7 years after surgery
Basic cognitive status as measured by the Frontal Assessment Battery (FAB)
up to 5-7 years after surgery
Basic cognitive status as measured by the Montreal Cognitive Assessment (MoCA)
up to 5-7 years after surgery
Eligibility Criteria
The adult patients with coronary artery disease aged 45-75 years who were admitted for planned CABG at the Federal State Budgetary Scientific Institution of Research Institute of Complex Issues of Cardiovascular Diseases.
You may qualify if:
- Planned coronary surgery
- Written informed consent
You may not qualify if:
- Depression (BDI-II score more than 8)
- Dementia (MMSE score less than 24; FAB score less than 11; MoCA score less than 20)
- Life-threatening rhythm disturbances
- Chronic heart failure (NYHA functional class III and higher)
- Chronic obstructive pulmonary disease
- Malignant pathology
- Drug addiction
- Stroke
- Brain injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal State Budgetary Scientific Institution of Research Institute of Complex Issues of Cardiovascular Diseases
Kemerovo, 650002, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Olga L Barbarash, MD, PhD
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Neurovascular Pathology Lab
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 29, 2021
Study Start
February 2, 2011
Primary Completion
December 31, 2021
Study Completion
December 31, 2023
Last Updated
December 29, 2021
Record last verified: 2021-12