Postoperative Cognitive DysfunctionNCT05172362
Short-Term and Long-Term Cognitive Outcomes in Adults After Cardiac Surgery
An observational study of Postoperative Cognitive Dysfunction and Coronary Artery Disease, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Coronary Artery Disease
- How many people
- 250 participants
- Where
- 1 siteRussia
- Study dates
- 2 Feb 2011to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Planned coronary surgery
- Written informed consent
Who cannot join
- 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
Show all 9Show fewer
- Drug addiction
- Stroke
- Brain injuries
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Scientific Institution of Research Institute of Complex Issues of Cardiovascular Diseases
Kemerovo, 650002
Olga L Barbarash, MD, PhD, olb61@mail.ru
About this study
Official title: Short-Term and Long-Term Cognitive Outcomes in Adults After Cardiac Surgery: Domain-Specific Cognitive Changes, EEG and Neurovascular Unit Markers
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).
Read the detailed description
Coronary artery bypass grafting (CABG) is one of the most effective ways to surgically correct coronary atherosclerosis. However, the postoperative cognitive decline often develops in patients who undergo CABG. According to various studies, the frequency of postoperative cognitive dysfunction (POCD) after cardiac surgery is 50-80% at the time of hospital discharge and remains present in 20-50% of patients in long-term period after surgery. The presence of POCD is associated with a decrease in surgery effectiveness and impairments in daily functioning, and is a reliable marker of unfavourable long-term prognosis (e.g., dementia and death). This prospective randomized study will be included the adult patients with stable coronary artery disease aged 45-75 years who admitted for planned CABG at the Federal State Budgetary Scientific Institution of Research Institute of Complex Issues of Cardiovascular Diseases. The study complies with the Good Clinical Practice standards and the principles of the Declaration of Helsinki. The study protocol was approved by the institutional Ethics Committee (01/2011-2520). Prior to inclusion in the study, all participants will be provided written informed consent and underwent basic cognitive screening using the Mini-Mental State Examination (MMSE) scale. The exclusion criteria are as follows: life-threatening rhythm disturbances, chronic heart failure (NYHA functional class III and higher), chronic obstructive pulmonary disease, malignant pathology, drug addiction, stroke, and other brain injuries. All the patients will be underwent general medical, neurological, instrumental examinations and extended neuropsychological assessment using the software Status PF as well as electroencephalographical examination 3-5 days before CABG, at 7-10 days after surgery and 5-7 years after CABG. POCD is determined by a 20% decrease in the cognitive indicator compared to that at baseline on 20% of the tests included in the Status PF battery. The serum concentrations of markers of the neurovascular unit (S100b, NSE, and BDNF) will be measured 3-5 days before CABG, within the first 24 h after surgery, and at 7-10 days after CABG.
In summary, the long-term neurophysiological effects following cardiac surgery are poorly understood. Moreover, little is known about the structure of cognitive impairment during the long-term postoperative period and the corresponding functional activity of the brain. The detection of minimal or subclinical signs of brain dysfunction following CABG is still under debate. Prior studies have shown the relationship between EEG abnormalities and cognitive impairment. However, little is known about EEG changes and concentrations of markers of the neurovascular unit in patients after on-pump CABG. To facilitate and improve the diagnostic accuracy, detailed neuropsychological examination using the multichannel digital EEG, serum concentrations of markers of the neurovascular unit and psychometric tests may be used to detect the long-term brain changes associated with postoperative cognitive impairment. Therefore, the study aims to evaluate the neurophysiological outcomes of patients 5-7 years after CABG.
- Keywords
- coronary artery bypass grafting, brain activity, markers of neurovascular unit, cognitive test
- Medical subject headings
- Postoperative Cognitive Complications, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 5-7 years after surgery
Secondary outcomes (3)
Basic cognitive status as measured by the Mini-Mental State Examination (MMSE) scale
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used to measure cognitive status.The possible score in the MMSE test ranged between 0 (minimum) and 30 (maximum).The MMSE tests in this study were given in validated Russian-language versions.
Measured: up to 5-7 years after surgery
Basic cognitive status as measured by the Frontal Assessment Battery (FAB)
Frontal Assessment Battery (FAB) is a test for estimation of frontal type cognitive disorders.The possible score in the FAB test ranged between 0 (minimum) and 18 (maximum). The FAB tests in this study were given in validated Russian-language versions.
Measured: up to 5-7 years after surgery
Basic cognitive status as measured by the Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) is a 30-point test used for screening assessment of cognitive impairment. MoCA scores range between 0 and 30, a score of 26 or over is considered to be normal.The MoCA tests in this study were given in validated Russian-language versions.
Measured: up to 5-7 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start2 Feb 2011
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Novosibirsk State University
- Responsible party
- Principal investigator, Olga Trubnikova, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Investigators
- Olga L Barbarash, MD, PhD, Study director, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172362
- Sponsor's protocol ID
- 01/2011-2520
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term and Long-Term Cognitive Outcomes in Adults After Cardiac Surgery: Domain-Specific Cognitive Changes, EEG and Neurovascular Unit Markers
- ClinicalTrials.gov ID
- NCT05172362
- Acronym / sponsor ID
- 01/2011-2520
- Keywords
- coronary artery bypass grafting, brain activity, markers of neurovascular unit, cognitive test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
- Collaborators
- Novosibirsk State University
- Study start
- 2 Feb 2011 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Dec 2021 (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.
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).
Detailed description
Coronary artery bypass grafting (CABG) is one of the most effective ways to surgically correct coronary atherosclerosis. However, the postoperative cognitive decline often develops in patients who undergo CABG. According to various studies, the frequency of postoperative cognitive dysfunction (POCD) after cardiac surgery is 50-80% at the time of hospital discharge and remains present in 20-50% of patients in long-term period after surgery. The presence of POCD is associated with a decrease in surgery effectiveness and impairments in daily functioning, and is a reliable marker of unfavourable long-term prognosis (e.g., dementia and death). This prospective randomized study will be included the adult patients with stable coronary artery disease aged 45-75 years who admitted for planned CABG at the Federal State Budgetary Scientific Institution of Research Institute of Complex Issues of Cardiovascular Diseases. The study complies with the Good Clinical Practice standards and the principles of the Declaration of Helsinki. The study protocol was approved by the institutional Ethics Committee (01/2011-2520). Prior to inclusion in the study, all participants will be provided written informed consent and underwent basic cognitive screening using the Mini-Mental State Examination (MMSE) scale. The exclusion criteria are as follows: life-threatening rhythm disturbances, chronic heart failure (NYHA functional class III and higher), chronic obstructive pulmonary disease, malignant pathology, drug addiction, stroke, and other brain injuries. All the patients will be underwent general medical, neurological, instrumental examinations and extended neuropsychological assessment using the software Status PF as well as electroencephalographical examination 3-5 days before CABG, at 7-10 days after surgery and 5-7 years after CABG. POCD is determined by a 20% decrease in the cognitive indicator compared to that at baseline on 20% of the tests included in the Status PF battery. The serum concentrations of markers of the neurovascular unit (S100b, NSE, and BDNF) will be measured 3-5 days before CABG, within the first 24 h after surgery, and at 7-10 days after CABG.
In summary, the long-term neurophysiological effects following cardiac surgery are poorly understood. Moreover, little is known about the structure of cognitive impairment during the long-term postoperative period and the corresponding functional activity of the brain. The detection of minimal or subclinical signs of brain dysfunction following CABG is still under debate. Prior studies have shown the relationship between EEG abnormalities and cognitive impairment. However, little is known about EEG changes and concentrations of markers of the neurovascular unit in patients after on-pump CABG. To facilitate and improve the diagnostic accuracy, detailed neuropsychological examination using the multichannel digital EEG, serum concentrations of markers of the neurovascular unit and psychometric tests may be used to detect the long-term brain changes associated with postoperative cognitive impairment. Therefore, the study aims to evaluate the neurophysiological outcomes of patients 5-7 years after CABG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Planned coronary surgery
- Written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative cognitive dysfunction
Time frame: up to 5-7 years after surgery
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).
3 secondary outcomes
Basic cognitive status as measured by the Mini-Mental State Examination (MMSE) scale
Time frame: up to 5-7 years after surgery
Basic cognitive status as measured by the Frontal Assessment Battery (FAB)
Time frame: up to 5-7 years after surgery
Basic cognitive status as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: up to 5-7 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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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. This study is not recruiting at the moment.
Olga L Barbarash, MD, PhD study director
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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 Postoperative Cognitive Dysfunction and Coronary Artery Disease, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga A Trubnikova, MD, PhD (+73842345384, olgalet17@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive dysfunction (time frame: up to 5-7 years after surgery). 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 29 Dec 2021.