Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01625754
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2012-05-24
Brief Title:
The Heart-Mind Connection Evaluating the Association Between Ceramides and Cognitive Decline in Coronary Artery Disease
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
The Heart-Mind Connection Evaluating the Association Between Ceramides and Cognitive Decline in Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many studies have shown that those with coronary artery disease CAD have a more rapid decline in memory than expected and that they are at an increased risk of developing dementia It is not understood how memory decline is linked to CAD however it has recently been discovered that certain byproducts of fat breakdown involved in the development of CAD called ceramides can harm brain cells In the present study the investigators will recruit 129 CAD patients from a cardiac rehabilitation facility and measure memory performance and blood ceramide concentrations at baseline 3 months and 6 months The investigators will also measure important blood messengers of inflammation and assess whether they are associated with ceramide production In addition relationships between ceramides and other aspects of brain function such as thinking speed and the ability to plan and sort information will be explored
Detailed Description:
Coronary artery disease CAD affects about 198 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 225 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-MSMS 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 C220 and C240 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 C220 and C240 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
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-MSMS 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 C220 and C240 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 C220 and C240 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None