Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000136404
Ethics application status
Approved
Date submitted
19/02/2007
Date registered
20/02/2007
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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
Secondary ID [1] 260023 0
Nil
Universal Trial Number (UTN)
Trial acronym
Dementia In Response to Endovascular and Cardiac surgical Therapies (DIRECT) Study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients presenting for coronary angiography (CA). 1629 0
Condition category
Condition code
Neurological 1737 1737 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 1612 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2417 0
Incidence of dementia.
Timepoint [1] 2417 0
12 and 24 months
Secondary outcome [1] 4190 0
Incidence of PPCD
Timepoint [1] 4190 0
6 days, 3, 12 & 24 months

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
25/06/2008
Date of last participant enrolment
Anticipated
Actual
6/05/2013
Date of last data collection
Anticipated
Actual
29/11/2013
Sample size
Target
510
Accrual to date
Final
369
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1887 0
Government body
Name [1] 1887 0
National Health and Medical Research Council project grant # 447709
Country [1] 1887 0
Australia
Primary sponsor type
Individual
Name
A/Prof David Scott
Address
St. Vincent's Hospital, PO BOX 2900, Fitzroy, Melbourne, Victoria 3065
Country
Australia
Secondary sponsor category [1] 1701 0
Individual
Name [1] 1701 0
A/Prof Brendan Silbert
Address [1] 1701 0
St. Vincent's Hospital, PO BOX 2900, Fitzroy, Melbourne, Victoria
Country [1] 1701 0
Australia
Secondary sponsor category [2] 1702 0
Individual
Name [2] 1702 0
Dr Michael Yii
Address [2] 1702 0
St. Vincent's Hospital, PO BOX 2900, Fitzroy, Melbourne, Victoria
Country [2] 1702 0
Australia
Secondary sponsor category [3] 1703 0
Individual
Name [3] 1703 0
Prof David Ames
Address [3] 1703 0
St. George's, St. Vincent's Health, PO BOX 2900, Fitzroy, Melbourne, Victoria
Country [3] 1703 0
Australia
Secondary sponsor category [4] 1704 0
Individual
Name [4] 1704 0
A/Prof Andrew MacIsaac
Address [4] 1704 0
St. Vincent's Hospital, PO BOX 2900, Fitzroy, Melbourne, Victoria
Country [4] 1704 0
Australia
Secondary sponsor category [5] 1705 0
Individual
Name [5] 1705 0
Prof Konrad Jamrozik
Address [5] 1705 0
c/o St. Vincent's Hospital, PO BOX 2900, Fitzroy, Melbourne, Victoria
Country [5] 1705 0
Australia
Secondary sponsor category [6] 1706 0
Individual
Name [6] 1706 0
Prof Paul Maruff
Address [6] 1706 0
Neurosciences, University of Melbourne, Parkville, Victoria
Country [6] 1706 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3511 0
St. Vincent's Hospital
Ethics committee address [1] 3511 0
Ethics committee country [1] 3511 0
Australia
Date submitted for ethics approval [1] 3511 0
Approval date [1] 3511 0
17/05/2007
Ethics approval number [1] 3511 0
Ethics committee name [2] 3512 0
St. Vincent's & Mercy Private Hospital
Ethics committee address [2] 3512 0
Ethics committee country [2] 3512 0
Australia
Date submitted for ethics approval [2] 3512 0
Approval date [2] 3512 0
Ethics approval number [2] 3512 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27546 0
Address 27546 0
Country 27546 0
Phone 27546 0
Fax 27546 0
Email 27546 0
Contact person for public queries
Name 10801 0
Ms. Lis Evered
Address 10801 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 10801 0
Australia
Phone 10801 0
+61 3 92882251
Fax 10801 0
+61 3 92884255
Email 10801 0
lis.evered@svhm.org.au
Contact person for scientific queries
Name 1729 0
Associate Professor David Scott
Address 1729 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 1729 0
Australia
Phone 1729 0
+61 3 92884253
Fax 1729 0
+61 3 92884255
Email 1729 0
david.scott@svhm.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.