Coronary Artery DiseaseCONFUSENCT04081649
Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery
An observational study of Coronary Artery Disease and Cognitive Impairment, run by Dr. Gordon Boyd at 1 site in Canada.
Trial summary
The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cognitive Impairment, Delirium
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2014to 30 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing non-emergent surgery will be recruited from the perioperative assessment clinic by a trained researcher.
Who may be able to join
- adult patients undergoing coronary artery bypass surgery +/- valvular surgery
Who cannot join
- pre-existing cognitive impairment or neurodegenerative condition
- any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kingston General Hospital
Kingston, Ontario, K7L3V7
John G Boyd, MD, PhD, 613-549-6666 ext. 6228, 2jgb1@queensu.ca
About this study
The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. The investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. Furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rSO2) desaturations, as measured by near-infrared spectroscopy (NIRS) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the KINARM.
- Conditions
- Coronary Artery Disease, Cognitive Impairment, Delirium
- Medical subject headings
- Coronary Artery Disease, Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Patients undergoing non-emergent cardiac surgery for coronary bypass graft and/or valvular replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month cognitive outcome-Repeatable Battery of Neuropsychological Status (RBANS) Total Scale
Participants will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS assesses 5 cognitive domains (language, visuospatial, immediate memory, delayed memory, and attention). The individual domain scores are compiled to provide at total cognitive score (Total Scale), which is age-adjusted. The population normative value is 100 +/- 24 (1.96 SD).
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-visually guided reaching
This centre-out reaching task assesses basic visuospatial skills and sensorimotor control. The subject's hand is represented by a white dot. Each subject is then instructed to bring the white dot quickly and accurately to the red target as they appear on the screen. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-arm position matching
Patients are instructed to mirror-match the movement and final position of the robot-controlled arm. This task is performed twice to obtain data on both arms. Patients will require intact proprioceptive functioning to process information on where their limb is in the horizontal space. This arm position matching task has been shown to determine the degree of position sense impairment in subjects following stroke. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-reverse visually guided reaching
This task is presented similarly to the visual guided reaching task. However, the movement of the white dot is now reversed compared to the movement of the patient's hand. To successfully complete the task, patients must move their hand away from the target, thereby reaching the red target with the white dot. This is a more complex reaching task, requiring inhibitory control to not automatically reach towards the red target and a cognitive rule to move the white cursor by moving in the opposite direction. Visuomotor impairments of this nature have been described in individuals at risk of developing Alzheimer's disease. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-ball on bar
Patients are instructed to use a virtual bar, generated between their hands, to balance a virtual ball as it appears on the screen. The subject must then bring the balanced ball on bar to different target locations in virtual space. This task consists of three levels: 1) ball fixed to bar, 2) ball moves along bar based on bar orientation, 3) ball can roll freely along bar. This task assesses bimanual motor control. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-object hit
In this task, the participants' hands are represented by paddles. Subjects are instructed to hit balls falling down from the top of the screen towards them. As the task progresses, the balls begin to fall more frequently and increase in speed, making the task gradually more difficult. This simple task measures sensorimotor function and decision-making. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-object hit and avoid
This task is similar to the object hit task, where patients use the robot's handles to hit objects falling from the top of the screen towards them. In this task however, patients are instructed to only hit two target shapes while avoiding all other shapes (i.e distractors). The Object hit \& avoid task therefore requires additional cognitive functions related to attention to identify each shape and inhibitory control to avoid the distractors. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-spatial span
A series of squares light up on the screen in a particular sequence. Within a 3-by-4 grid of squares, patients are required to replay the sequence by reaching with their dominant hand to the correct squares. This task assesses visuospatial working memory, and is similar to the Corsi block-tapping task. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
12 month cognitive outcome-KINARM robotic assessment-trail making
This task is a quantitative version of the standard pen-and-paper neuropsychological test. In trailing making part A, patients are instructed to connect the numbers 1 through 25. The trail making part B task requires subjects to connect the dots by alternating numbers and letters (1-A-2-B-3-C, etc.). This task assesses executive function related to task switching. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
Measured: 12 months
Secondary outcomes (2)
Cognitive trajectory (changes in KINARM and RBANS performance from pre-surgery, to 3- and 12-months post-operative)
This will be assessed with the KINARM robot and the RBANS (described above)
Measured: Pre-operative, 3 months post-operative, and 12-months post-operative
Physiological determinants of rSO2
Intraoperative hemodynamic and physiological variables will be collected during the operation (eg. mean arterial pressure (mmHg), heart rate (beats per minute), peripheral oxygen saturation (%)) to determine the predictors of rSO2. A linear model will be created to demonstrate the relative contribution each of these predictors has to cerebral oxygenation (rSO2-single outcome variable).
Measured: Intraoperative (3-6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Jun 2014
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gordon Boyd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Gordon Boyd, Queen's University
- Investigators
- J. Gordon Boyd, MD, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081649
- Sponsor's protocol ID
- DMED-1672-14
- Acronym
- CONFUSE
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2019
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will be willing to share IPD following the publication of our study in peer reviewed literature.
Publications
Semrau JS, Scott SH, Hamilton AG, Petsikas D, Payne DM, Bisleri G, Saha T, Boyd JG. Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry. BMJ Open. 2019 Dec 3;9(12):e032935. doi: 10.1136/bmjopen-2019-032935.
PubMed 31796491
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Neurological Functioning After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04081649
- Acronym / sponsor ID
- CONFUSE / DMED-1672-14
- Conditions
- Coronary Artery Disease, Cognitive Impairment, Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Dr. Gordon BoydUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Sep 2019 (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.
The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. The investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. Furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rSO2) desaturations, as measured by near-infrared spectroscopy (NIRS) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the KINARM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | –Patients undergoing non-emergent cardiac surgery for coronary bypass graft and/or valvular replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing non-emergent surgery will be recruited from the perioperative assessment clinic by a trained researcher.
Key inclusion criteria (1 listed)
- adult patients undergoing coronary artery bypass surgery +/- valvular surgery
Key exclusion criteria (2 listed)
- pre-existing cognitive impairment or neurodegenerative condition
- any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)
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
12 month cognitive outcome-Repeatable Battery of Neuropsychological Status (RBANS) Total Scale
Time frame: 12 months
Participants will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS assesses 5 cognitive domains (language, visuospatial, immediate memory, delayed memory, and attention). The individual domain scores are compiled to provide at total cognitive score (Total Scale), which is age-adjusted. The population normative value is 100 +/- 24 (1.96 SD).
12 month cognitive outcome-KINARM robotic assessment-visually guided reaching
Time frame: 12 months
This centre-out reaching task assesses basic visuospatial skills and sensorimotor control. The subject's hand is represented by a white dot. Each subject is then instructed to bring the white dot quickly and accurately to the red target as they appear on the screen. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 month cognitive outcome-KINARM robotic assessment-arm position matching
Time frame: 12 months
Patients are instructed to mirror-match the movement and final position of the robot-controlled arm. This task is performed twice to obtain data on both arms. Patients will require intact proprioceptive functioning to process information on where their limb is in the horizontal space. This arm position matching task has been shown to determine the degree of position sense impairment in subjects following stroke. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 month cognitive outcome-KINARM robotic assessment-reverse visually guided reaching
Time frame: 12 months
This task is presented similarly to the visual guided reaching task. However, the movement of the white dot is now reversed compared to the movement of the patient's hand. To successfully complete the task, patients must move their hand away from the target, thereby reaching the red target with the white dot. This is a more complex reaching task, requiring inhibitory control to not automatically reach towards the red target and a cognitive rule to move the white cursor by moving in the opposite direction. Visuomotor impairments of this nature have been described in individuals at risk of developing Alzheimer's disease. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 month cognitive outcome-KINARM robotic assessment-ball on bar
Time frame: 12 months
Patients are instructed to use a virtual bar, generated between their hands, to balance a virtual ball as it appears on the screen. The subject must then bring the balanced ball on bar to different target locations in virtual space. This task consists of three levels: 1) ball fixed to bar, 2) ball moves along bar based on bar orientation, 3) ball can roll freely along bar. This task assesses bimanual motor control. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 month cognitive outcome-KINARM robotic assessment-object hit
Time frame: 12 months
In this task, the participants' hands are represented by paddles. Subjects are instructed to hit balls falling down from the top of the screen towards them. As the task progresses, the balls begin to fall more frequently and increase in speed, making the task gradually more difficult. This simple task measures sensorimotor function and decision-making. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 month cognitive outcome-KINARM robotic assessment-object hit and avoid
Time frame: 12 months
This task is similar to the object hit task, where patients use the robot's handles to hit objects falling from the top of the screen towards them. In this task however, patients are instructed to only hit two target shapes while avoiding all other shapes (i.e distractors). The Object hit \& avoid task therefore requires additional cognitive functions related to attention to identify each shape and inhibitory control to avoid the distractors. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 month cognitive outcome-KINARM robotic assessment-spatial span
Time frame: 12 months
A series of squares light up on the screen in a particular sequence. Within a 3-by-4 grid of squares, patients are required to replay the sequence by reaching with their dominant hand to the correct squares. This task assesses visuospatial working memory, and is similar to the Corsi block-tapping task. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
12 month cognitive outcome-KINARM robotic assessment-trail making
Time frame: 12 months
This task is a quantitative version of the standard pen-and-paper neuropsychological test. In trailing making part A, patients are instructed to connect the numbers 1 through 25. The trail making part B task requires subjects to connect the dots by alternating numbers and letters (1-A-2-B-3-C, etc.). This task assesses executive function related to task switching. This task is quantified by several parameters (eg. limb speed, reaction time), which are compiled into an overall task score using the Mahalanobis distance, and further converted to an age-, gender, and handedness matched z-score. A z-score greater than 1.96 is considered abnormal.
2 secondary outcomes
Cognitive trajectory (changes in KINARM and RBANS performance from pre-surgery, to 3- and 12-months post-operative)
Time frame: Pre-operative, 3 months post-operative, and 12-months post-operative
Physiological determinants of rSO2
Time frame: Intraoperative (3-6 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Derived from this study: PubMed 31796491Semrau JS, Scott SH, Hamilton AG, Petsikas D, Payne DM, Bisleri G, Saha T, Boyd JG. Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry. BMJ Open. 2019 Dec 3;9(12):e032935. doi: 10.1136/bmjopen-2019-032935.
- Individual participant dataSharing planned: Yes. We will be willing to share IPD following the publication of our study in peer reviewed literature.
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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.
J. Gordon Boyd, MD, PhD principal investigator
Queen's University
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 Coronary Artery Disease and Cognitive Impairment, run by Dr. Gordon Boyd at 1 site in Canada.
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 1 inclusion and 2 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 26 Dec 2023. 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 Canada. 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 J. Gordon Boyd, MD, PhD (6135392754, 2jgb1@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 month cognitive outcome-Repeatable Battery of Neuropsychological Status (RBANS) Total Scale (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081649, which also lists 1 linked publication.
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 26 Dec 2023.