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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Olga A Trubnikova, MD, PhD contact

+73842345384

olgalet17@mail.ru

Russia1 site, 1 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

    Recruiting

Other trials in Russia

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.

  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).

    Measured: up to 5-7 years after surgery

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted29 Dec 2021
  2. Study start2 Feb 2011
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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)
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

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.

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