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Trial registered on ANZCTR


Registration number
ACTRN12607000051448
Ethics application status
Approved
Date submitted
21/12/2006
Date registered
16/01/2007
Date last updated
6/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Cardiac Interventions, Surgery and Cognitive Outcome (CISCO) Study
Scientific title
The prospective observational CISCO (Cardiac Interventions, Surgery and Cognitive Outcome) study will document the preoperative neuropsychological status of patients presenting for coronary angiography (CA) and relate this to cognitive outcomes over the succeeding three months, taking into account their management (medical; Percutaneous Coronary Intervention (PCI); or Coronary Artery Bypass Graft (CABG) surgery).
Secondary ID [1] 260029 0
nil
Universal Trial Number (UTN)
Trial acronym
The CISCO Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients presenting for Coronary Angiography (CA). 1544 0
Condition category
Condition code
Cardiovascular 1643 1643 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To test whether Mild Cognitive Impairment (MCI) prior to CA is associated with an increased risk of PPCD (Post Procedural Cognitive Dysfunction) and to compare cognitive changes between management techniques (medical; PCI; CABG surgery). Patients will complete a battery of conventional and computerised neuropsychological tests preoperatively. They will then complete the computerised test battery at 24 hours, 6 days and 3 months post intervention to identify changes in cognitive function. The tests takes about 1 hour to complete. Quality of Life (QoL), mood, Activities of Daily Living (ADL) and Clinical Dementia Rating (CDR) will be assessed preoperatively and at 3 months post intervention.
Intervention code [1] 1520 0
Not applicable
Comparator / control treatment
comparator will be the group of patients undergoing coronary angiography who do not have coronary artery disease.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2267 0
Prevalence of MCI (Mild Cognitive Impairment)
Timepoint [1] 2267 0
Baseline
Primary outcome [2] 2268 0
Incidence of PPCD (Post Procedural Cognitive Dysfunction)
Timepoint [2] 2268 0
24hours, 6 days and 3 months
Primary outcome [3] 2269 0
Incidence of POCD (Post Operative Cognitive Dysfunction)
Timepoint [3] 2269 0
24hours, 6 days and 3 months
Secondary outcome [1] 3967 0
Relationship of cardiac risk factors to prevalence of MCI
Timepoint [1] 3967 0
Baseline
Secondary outcome [2] 3968 0
Time course of PPCD
Timepoint [2] 3968 0
24hours, 6 days and 3 months
Secondary outcome [3] 3969 0
Quality of Life
Timepoint [3] 3969 0
Baseline and 3 months
Secondary outcome [4] 3970 0
Activities of Daily Living
Timepoint [4] 3970 0
Baseline and 3 months
Secondary outcome [5] 3971 0
Clinical dementia rating
Timepoint [5] 3971 0
Baseline and 3 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
5/07/2007
Date of last participant enrolment
Anticipated
Actual
20/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1789 0
Government body
Name [1] 1789 0
National Health and Medical Research Council project grant # 454622
Country [1] 1789 0
Australia
Primary sponsor type
Individual
Name
A/Prof David Scott
Address
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900 Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 1601 0
Individual
Name [1] 1601 0
A/Prof Brendan Silbert
Address [1] 1601 0
Department of Anaesthesia, St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [1] 1601 0
Australia
Secondary sponsor category [2] 1602 0
Individual
Name [2] 1602 0
Dr Michael Yii
Address [2] 1602 0
Department of Cardiothoracic Surgery, St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [2] 1602 0
Australia
Secondary sponsor category [3] 1603 0
Individual
Name [3] 1603 0
Prof David Ames
Address [3] 1603 0
St. Georges Campus, St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [3] 1603 0
Australia
Secondary sponsor category [4] 1604 0
Individual
Name [4] 1604 0
A/Prof Andrew MacIsaac
Address [4] 1604 0
Department of Cardiology, St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [4] 1604 0
Australia
Secondary sponsor category [5] 1605 0
Individual
Name [5] 1605 0
Dr Richard Gerraty
Address [5] 1605 0
Department of Neurology, Alfred Hospital, Commercial Rd. Prahran
Country [5] 1605 0
Australia
Secondary sponsor category [6] 1606 0
Individual
Name [6] 1606 0
Prof Konrad Jamrozik
Address [6] 1606 0
c/o St. Vincent's Hospital, PO Box 2900 Fitzroy 3065
Country [6] 1606 0
Australia
Secondary sponsor category [7] 1607 0
Individual
Name [7] 1607 0
Prof Paul Myles
Address [7] 1607 0
Department of Anaesthesia & Pain Management, Alfred Hospital, Commercial Rd. Prahran
Country [7] 1607 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 27454 0
A/Prof David Scott
Address 27454 0
Centre for Anaesthesia and Cognitive Function
Department of Anaesthesia
St Vincent's Hospital
PO Box 2900
Fitzroy 3065
Victoria
Country 27454 0
Australia
Phone 27454 0
+61 3 9288 4253
Fax 27454 0
Email 27454 0
david.scott@svhm.org.au
Contact person for public queries
Name 10709 0
Dr Lis Evered
Address 10709 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 10709 0
Australia
Phone 10709 0
+61 3 92882251
Fax 10709 0
+61 3 92884255
Email 10709 0
lis.evered@svhm.org.au
Contact person for scientific queries
Name 1637 0
Associate Professor David Scott
Address 1637 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 1637 0
Australia
Phone 1637 0
+61 3 92884253
Fax 1637 0
+61 3 92884255
Email 1637 0
david.scott@svhm.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseCognitive function before and after left heart catheterization.2018https://dx.doi.org/10.1161/JAHA.117.008004
N.B. These documents automatically identified may not have been verified by the study sponsor.