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The impact on cognitive function and dementia of diagnostic and treatment alternatives for coronary artery disease. The Dementia In Response to Endovascular and Cardiac surgical Therapies (DIRECT) Study.

This prospective observational study will document the preoperative neuropsychological status of patients presenting for coronary angiography (CA) and relate this to cognitive outcomes, including the rate of conversion to dementia, over the succeeding two years

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12607000136404
Acronym
Dementia In Response to Endovascular and Cardiac surgical Therapies (DIRECT) Study.
Enrollment
369
Registered
2007-02-20
Start date
2008-06-25
Completion date
2013-05-06
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Individuals with symptomatic CAD probably constitute a population at high risk for accelerated decline in cognitive function, because of the overlap between Alzheimer’s disease, vascular dementia and the risk factors for both. Appropriate clinical decision-making for these patients depends on the accurate understanding of the prevalence of prodromal conditions such as MCI, the incidence of PPCD and how they affect the rate of conversion to dementia in these patients.

Interventions

To test whether the onset of dementia during the two years following coronary intervention(s) is related to Mild Cognitive Impairment (MCI) prior to CA and the occurrence of Post Procedural Cognitive Dysfunction (PPCD). Patients will complete a battery of conventional and computerised neuropsychological tests preoperatively. The conventional test battery is a set of eight paper and pencil tests (eg. trail making tests A and B, digit symbol test, Rey Auditory Verbal Learning test) and the compute

To test whether the onset of dementia during the two years following coronary intervention(s) is related to Mild Cognitive Impairment (MCI) prior to CA and the occurrence of Post Procedural Cognitive Dysfunction (PPCD). Patients will complete a battery of conventional and computerised neuropsychological tests preoperatively. The conventional test battery is a set of eight paper and pencil tests (eg. trail making tests A and B, digit symbol test, Rey Auditory Verbal Learning test) and the computerised battery is a version of Cogstate®. The tests take about one hour to complete. They will then complete the computerised test battery at 6 days, 3 months, 12 months and 24 months post intervention to identify changes in cognitive function. Quality of Life (QoL), mood, Activities of Daily Living (ADL) and Clinical Dementia Rating (CDR) will be assessed preoperatively and at 12 months and 24 months.

Sponsors

A/Prof David Scott
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Scheduled for elective CA who do not have neurological (as opposed to neuropsychological) deficit or any contraindication to undergoing neuropsychological testing, and have given informed consent. The patients must reside in accessible proximity to the hospital to enable investigators to administer neuropsychological testing at home.

Exclusion criteria

i.Pre-existing neurological or clinically evident neurovascular disease (e.g. TIA, stroke);ii.Dementia: a score less than 26 on the Mini Mental State Examination (MMSE) or CDR > 1;iii.Anticipated difficulty with neuropsychological assessment such as: English not being the prime language; blindness; deafness;iv.Geographical remoteness or medical co-morbidity that may lead to complications and loss to follow-up.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026