Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000052437
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
Coronary Angiography, Transcranial Doppler and Cognitive Health (CATCH) Study
Scientific title
The prospective observational CATCH study will test whether the microembolic count during Left Heart Catheterisation (LHC) for either Coronary Angiography (CA) or Percutaneous Coronary Intervention (PCI) is associated with cognitive change following the procedure and assess the time course of these changes over a 3 month period.
Secondary ID [1] 282984 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The CATCH Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients scheduled to undergo Left Heart Catheterisation (LHC) for either Coronary Angiography (CA) or Percutaneous Coronary Intervention (PCI). 1545 0
Condition category
Condition code
Cardiovascular 1644 1644 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 microembolic count during left heart catheterisation (LHC) for coronary angiography (CA) or Percutaneous Coronary Intervention (PCI) is associated with cognitive change following the procedure. Patients will complete a battery of conventional and computerised neuropsychological tests preoperatively. The tests take about 1 hour to complete. The computerised battery of tests will then be administered one week, six weeks and 3 months post procedure to identify changes in cognitive function. Quality of Life (QoL), mood, Acitivities of Daily Living (ADL) and Clinical Dementia Rating (CDR) will be assessed preoperatively and 3 months post procedure. Trans Cranial Doppler (TCD) monitoring will be performed for a 15 minute epoch immediately before angiography. The signal will be recorded on audio tape for later review. Monitoring will be continuous during the angiogram. The total number of microemboli for the whole angiogram will be used for the analysis.
Intervention code [1] 1519 0
Not applicable
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2270 0
PPCD (Post Procedural Cognitive Dysfunction)
Timepoint [1] 2270 0
6 days, 6 weeks and 3 months
Secondary outcome [1] 3972 0
Clinical risk factors associated with cognitive change after LHC
Timepoint [1] 3972 0
6 days, 6 weeks and 3 months
Secondary outcome [2] 3973 0
Circulatory biomarkers associated with cognitive change after LHC
Timepoint [2] 3973 0
6 days, 6 weeks and 3 months
Secondary outcome [3] 3974 0
Volume of contrast and association with cognitive change after LHC
Timepoint [3] 3974 0
6 days, 6 weeks and 3 months
Secondary outcome [4] 3975 0
Duration of procedure and associations with cognitive change after LHC
Timepoint [4] 3975 0
6 days, 6 weeks and 3 months

Eligibility
Key inclusion criteria
Scheduled for elective LHC, who do not have neurological 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 follow-up 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
1.Pre-existing neurological or neurovascular disease (e.g. stroke);2.A score of less than 26 on the Mini Mental State Examination 3.Anticipated difficulty with neuropsychological assessment such as: English not being the prime language; blindness; deafness;4.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
31/10/2007
Date of last participant enrolment
Anticipated
Actual
5/06/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1790 0
Charities/Societies/Foundations
Name [1] 1790 0
National Heart Foundation Research Grant-In-Aid
Country [1] 1790 0
Australia
Primary sponsor type
Individual
Name
A/Prof David Scott
Address
St. Vincent's Hospital
PO Box 2900
Fitzroy 3065
Victoria
Country
Australia
Secondary sponsor category [1] 1608 0
Individual
Name [1] 1608 0
A/Prof Brendan Silbert
Address [1] 1608 0
St. Vincent's Hospital
PO Box 2900
Fitzroy 3065
Victoria
Country [1] 1608 0
Australia
Secondary sponsor category [2] 1609 0
Individual
Name [2] 1609 0
A/Prof Andrew Macisaac
Address [2] 1609 0
St. Vincent's Hospital
PO Box 2900
Fitzroy 3065
Victoria
Country [2] 1609 0
Australia
Secondary sponsor category [3] 1610 0
Individual
Name [3] 1610 0
Dr Richard Gerraty
Address [3] 1610 0
St. Vincent's Hospital
PO Box 2900
Fitzroy 3065
Victoria
Country [3] 1610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289701 0
St. Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 289701 0
PO Box 2900
Fitzroy 3065
Victoria
Ethics committee country [1] 289701 0
Australia
Date submitted for ethics approval [1] 289701 0
Approval date [1] 289701 0
17/01/2007
Ethics approval number [1] 289701 0
172/06

Summary
Brief summary
Injecting dye into the heart is a common investigation that helps diagnose coronary artery disease. Although it is known that small bubbles of air are often injected during this procedure and may enter the brain, they have been generally thought to be harmless. We plan to measure cognitive function before and after the heart is studied to see if these small bubbles alter brain function.
Trial website
www.cognition.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27453 0
A/Prof David Scott
Address 27453 0
Centre for Anaesthesia and Cognitive Function
Department of Anaesthesia
St Vincent's Hospital
PO Box 2900
Fitzroy 3065
Victoria
Country 27453 0
Australia
Phone 27453 0
+61 3 9288 4253
Fax 27453 0
Email 27453 0
david.scott@svhm.org.au
Contact person for public queries
Name 10708 0
Dr Dr Lis Evered
Address 10708 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 10708 0
Australia
Phone 10708 0
+61 3 92882251
Fax 10708 0
+61 3 92884255
Email 10708 0
lis.evered@svhm.org.au
Contact person for scientific queries
Name 1636 0
A/Prof Associate Professor David Scott
Address 1636 0
Department of Anaesthesia
St. Vincent’s Hospital
P.O. Box 2900
Fitzroy, Melbourne VIC 3065
Country 1636 0
Australia
Phone 1636 0
+61 3 92884253
Fax 1636 0
+61 3 92884255
Email 1636 0
david.scott@svhm.org.au

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No Supporting Document Provided



Results publications and other study-related documents

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