The Heart-Mind Connection: Evaluating the Association Between Ceramides and Cognitive Decline in Coronary Artery Disease

NCT01625754 | Completed

• 1 other identifier: 279-2011
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Ceramides; Lipids

Outcome Measures

Primary Outcomes (1)

• Change in Verbal memory

  Verbal memory will be assessed using the California Verbal Learning Test, 2nd Edition (CVLT-II)

  6 months

Secondary Outcomes (2)

• Neuropsychiatric battery

  Baseline, 3 months, 6 months

• Montreal Cognitive Assessment (MoCA)

  Baseline, 3 months, 6 months

Study Arms (1)

Cardiac rehabilitation

This study recruits individuals that are currently participating in a cardiac rehabilitation exercise program.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

All individuals will be prescribed an exercise regimen according to their cardiac rehabilitation program

Cardiac rehabilitation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with coronary artery disease participating in a cardiac rehabilitation exercise program

You may qualify if:

• years of age
• speak and understand English
• evidence of CAD based on at least 1 of the following:
• previous hospitalization for myocardial infarction
• angiographic evidence of ≥ 50% blockage in ≥ 1 major coronary artery
• a prior revascularization procedure
• no recent (last 4 weeks) hospitalization for cardiac events such as acute myocardial infarction, unstable angina, congestive heart failure, ventricular arrhythmias, coronary revascularization, or Canadian Cardiovascular Society Class 4 angina

You may not qualify if:

• Type I diabetes
• hypothyroidism, Parkinson's disease, any diagnosis of dementia including Alzheimer's disease, inflammatory disease (irritable bowel syndrome, Crohn's, arthritis, etc.), Huntington's chorea, brain tumour, other conditions that may affect cognitive performance such as history of epilepsy, subdural hematoma, traumatic brain injury, and clinical stroke, progressive supranuclear paralysis, Killip Class III or IV states, multiple sclerosis, severely disrupted liver/ kidney/ lung function
• use of hypnotics, antipsychotics, antidepressants, and anticholinergic medication
• premorbid psychiatric diagnosis of schizophrenia or bipolar disorder
• significant cognitive impairment (MMSE ≤ 24)
• diagnosis of any current Axis I disorder other than depression, phobias or nicotine abuse/dependence

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Toronto Rehabilitation Institute - Cardiac Rehab

Toronto, Ontario, M4G 1R7, Canada

Location

Related Publications (2)

• Chan P, Saleem M, Herrmann N, Mielke MM, Haughey NJ, Oh PI, Kiss A, Lanctot KL. Ceramide Accumulation Is Associated with Declining Verbal Memory in Coronary Artery Disease Patients: An Observational Study. J Alzheimers Dis. 2018;64(4):1235-1246. doi: 10.3233/JAD-180030.

  PMID: 30010121 RESULT

• Saleem M, Bandaru VV, Herrmann N, Swardfager W, Mielke MM, Oh PI, Shammi P, Kiss A, Haughey NJ, Rovinski R, Lanctot KL. Ceramides predict verbal memory performance in coronary artery disease patients undertaking exercise: a prospective cohort pilot study. BMC Geriatr. 2013 Dec 12;13:135. doi: 10.1186/1471-2318-13-135.

  PMID: 24330446 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for ApoE4 genotyping

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Krista Lanctôt, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Nathan Herrmann, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 21, 2012
• Study Start: November 1, 2011
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 31, 2024

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)