The Heart-Mind Connection: Evaluating the Association Between Ceramides and Cognitive Decline in Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT01625754|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2012
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Behavioral: Exercise|
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.
|Study Type :||Observational|
|Estimated Enrollment :||129 participants|
|Official Title:||The Heart-Mind Connection: Evaluating the Association Between Ceramides and Cognitive Decline in Coronary Artery Disease|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
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
- Change in Verbal memory [ Time Frame: 6 months ]Verbal memory will be assessed using the California Verbal Learning Test, 2nd Edition (CVLT-II)
- Neuropsychiatric battery [ Time Frame: Baseline, 3 months, 6 months ]The neuropsychiatric assessment battery recommended by the National Institute of Neurological Disorders and Stroke and the Canadian Stroke Network (NINDS-CSN) harmonized standards will be conducted
- Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, 3 months, 6 months ]The MoCA will be used to assess global cognition
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625754
|Toronto Rehabilitation Institute - Cardiac Rehab|
|Toronto, Ontario, Canada, M4G 1R7|
|Principal Investigator:||Krista Lanctôt, PhD||Sunnybrook Health Sciences Centre|
|Principal Investigator:||Nathan Herrmann, MD||Sunnybrook Health Sciences Centre|