The Heart-Mind Connection: Evaluating the Association Between Ceramides and Cognitive Decline in Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Heart-Mind Connection: Evaluating the Association Between Ceramides and Cognitive Decline in Coronary Artery Disease|
- Change in Verbal memory [ Time Frame: 6 months ] [ Designated as safety issue: No ]Verbal memory will be assessed using the California Verbal Learning Test, 2nd Edition (CVLT-II)
- Neuropsychiatric battery [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]The neuropsychiatric assessment battery recommended by NINDS-CSN harmonized standards will be conducted
- Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]The MoCA will be used to assess global cognition
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
This study recruits individuals that are currently participating in a cardiac rehabilitation exercise program.
All individuals will be prescribed an exercise regimen according to their cardiac rehabilitation program
Coronary artery disease (CAD) affects about 19.8% of Canadians over the age of 65 and significantly affects quality of life. Of particular importance, cognitive impairment, ranging from cognitive complaints to vascular dementia, is frequently part of the clinical presentation of CAD. Our own prospective pilot data suggest that 22.5% of CAD patients attending cardiac rehabilitation (CR) have evidence of cognitive impairment with lower verbal memory performance, a marker of hippocampal function, predicting poorer CR outcomes. The pathophysiological mechanisms that may contribute to cognitive decline in those with CAD have not been fully elucidated.
Ceramides are metabolites of sphingomyelin, lipid species enriched in the outer leaflet of the plasma membrane and cell organelles of all tissues. Higher peripheral blood concentrations of ceramides have been associated with the development and progression of CAD. We propose to use a specific and sensitive electrospray ionization-tandem mass spectrometry (ESI-MS/MS) assay to measure concentrations of ceramide species from human plasma and elucidate the relationship between ceramides and the change in verbal memory performance over 6 months in 129 subjects with CAD undergoing CR.
We hypothesize that higher plasma concentrations of the long chain ceramide species C22:0 and C24:0 will be associated with decline in verbal memory performance and overall cognitive performance as assessed by a standardized battery of cognitive tests recommended for the investigation of vascular cognitive impairment. We also hypothesize that changes in the plasma concentration of TNF-α (tumor necrosis factor-alpha) will be associated with changes in plasma concentrations of C22:0 and C24:0 over 6 months.
This study aims to clarify the significance of a novel mechanism involving ceramides and the propagation of inflammatory signals from the periphery to the brain in mediating neurodegeneration associated with CAD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625754
|Contact: Maisha Khan, BSc||(416) 480-6100 ext firstname.lastname@example.org|
|Contact: Abby Li, MSc, CCRP||(416) 480-6100 ext email@example.com|
|Toronto Rehabilitation Institute - Cardiac Rehab||Recruiting|
|Toronto, Ontario, Canada, M4G 1R7|
|Contact: Paul Oh, MD|
|Principal Investigator:||Krista Lanctôt, PhD||Sunnybrook Health Sciences Centre|
|Principal Investigator:||Nathan Herrmann, MD||Sunnybrook Health Sciences Centre|