Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000772640
Ethics application status
Approved
Date submitted
29/11/2005
Date registered
2/12/2005
Date last updated
3/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Assessment of Cognitive Function in Coronary Angiography
Scientific title
A Prospective Assessment of Cognitive Function in Patients with Cardiovascular Disease undergoing Elective Diagnostic Coronary Angiography
Secondary ID [1] 288066 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PACiFiCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Dysfunction in patients with Ischaemic Heart Disease 928 0
Condition category
Condition code
Cardiovascular 996 996 0 0
Other cardiovascular diseases
Mental Health 997 997 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational Study of patients undergoing cognitive angiography (and/or angioplasty and/or stenting). Patients are tested for cognitive impairment prior to procedure, prior to discharge and at 7 days
Intervention code [1] 777 0
Diagnosis / Prognosis
Comparator / control treatment
Participants underwent cognitive testing before and seven days after coronary angiography. Their post-intervention performance was compared with their pre-intervention performance. Comparison was also made with data provided by the Cogstate company, sourced from matched healthy controls undergoing a different study (2005).
Control group
Historical

Outcomes
Primary outcome [1] 1328 0
Change in cognitive impairment
Timepoint [1] 1328 0
Seven days post-coronary angiography
Secondary outcome [1] 2369 0
Nil
Timepoint [1] 2369 0
Nil

Eligibility
Key inclusion criteria
Booked for elective coronary angiography. The patients must reside in accessible proximity to the hospital to enable investigators to enable the investigators to do follow up testing in the patients' homes, must speak English, must not have pre-existing dementia.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2005
Actual
12/10/2005
Date of last participant enrolment
Anticipated
30/03/2007
Actual
30/03/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1094 0
Charities/Societies/Foundations
Name [1] 1094 0
St Vincent's Hospital Foundation
Country [1] 1094 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
St. vincent's Hospital Foundation
Address
St Vincent's Hospital Melbourne
Victoria Parade
FITZROY Vic. 3065
Country
Australia
Secondary sponsor category [1] 954 0
None
Name [1] 954 0
Nil
Address [1] 954 0
Country [1] 954 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2397 0
St. Vincent's Hospital Melbourne
Ethics committee address [1] 2397 0
St Vincent's Hospital Melbourne
Victoria Parade
FITZROY Vic. 3065
Ethics committee country [1] 2397 0
Australia
Date submitted for ethics approval [1] 2397 0
Approval date [1] 2397 0
03/10/2005
Ethics approval number [1] 2397 0

Summary
Brief summary
This study plans to measure mild difficulties in thinking (also known as cognitive impairment) in patients undergoing a coronary angiogram (which is an investigation using x-rays to look at the blood vessels in the heart). It will take measurements of thinking ability before and after the test to see if having the test leads to any changes in thinking ability. We will also ask about health problems related to heart disease such as high blood pressure and smoking.Patients who have heart disease are more likely to have problems with thinking compared with other people of similar age. Studies have also shown that having an angiogram may result in the release into the bloodstream of small particles which may be carried to the brain, potentially worsening thinking ability.We plan to ask 50 patients to participate. We will ask patients who are aged 65 years or older whose doctor has recommended that they have an angiogram,. We will use a computer test called Cogstate to test patients before and after the procedure. The computer tests have been shown to be easy and quick - just like playing a computer game. The testing will take 15 min or so and is done while the patients are waiting for the angiogram to be done. The tests will also be done a week after the angiogram to see if there is any change in thinking ability that may have been caused by the angiogram.
Trial website
Trial related presentations / publications
Cognitive function in patients undergoing coronary angiography
A N Devapalasundarum, B S Silbert, L A Evered, D A Scott, A I MacIsaac, P T Maruff
Heart Asia 2010;2:1 75-79 doi:10.1136/ha.2009.001230
Public notes

Contacts
Principal investigator
Name 35476 0
Dr Brendan Silbert
Address 35476 0
St Vincent's Hospital Melbourne
Victoria Pde
FITZROY Vic. 3065
Country 35476 0
Australia
Phone 35476 0
+61392882211
Fax 35476 0
Email 35476 0
[email protected]
Contact person for public queries
Name 9966 0
Dr James Griffiths
Address 9966 0
St. Vincent's Hospital
Fitzroy VIC 3065
Country 9966 0
Australia
Phone 9966 0
+61 3 92882211
Fax 9966 0
+61 3 92884255
Email 9966 0
[email protected]
Contact person for scientific queries
Name 894 0
Dr James Griffiths
Address 894 0
St. Vincent's Hospital
Fitzroy VIC 3065
Country 894 0
Australia
Phone 894 0
+61 3 92882211
Fax 894 0
+61 3 92884255
Email 894 0
[email protected]

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
No additional documents have been identified.