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Trial registered on ANZCTR
Registration number
ACTRN12607000648426
Ethics application status
Not yet submitted
Date submitted
15/12/2007
Date registered
20/12/2007
Date last updated
20/12/2007
Type of registration
Prospectively registered
Titles & IDs
Public title
Fundoscopy to assess evidence of microvascular thrombosis in cardiac surgery
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Scientific title
Fundoscopy to assess evidence of microvascular thrombosis in cardiac surgery
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Changes in microcirculation post cardiac surgery
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Condition category
Condition code
Inflammatory and Immune System
2747
2747
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Right pupil will be dilated with 1 drop of 0.1% tropicamide eye drops. Retinal and macular photographs will be taken pre-operatively and post-operatively
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Intervention code [1]
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Not applicable
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Comparator / control treatment
No Control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To assess changes eg emboli and inflammatory changs in the retinal circulation post cardiac surgery. No other instruments besides retinal photographs will be used
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Assessment method [1]
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Timepoint [1]
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1 day post operatively
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Secondary outcome [1]
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The retinal photographs will be assessed by researchers in ophthalmology who will measure the diameter and patency of the retinal blood vessels. Secondary outcomes may be any other incidental changes in the retina, such as evidence of oedema, post cardiac surgery.
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Assessment method [1]
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Timepoint [1]
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1 day post operatively
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Eligibility
Key inclusion criteria
Patients undergoing cardiac surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Previous cardiac surgery; eye disease; patient refusal; type 1 Diabetes Mellitus
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
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3065
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St Vincents Hospital
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Address [1]
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Victoria Parade
Fitzroy VIC 3065
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
St Vincents Hospital
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Address
Victoria Parade
Fitzroy VIC 3065
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Ethics committee address [1]
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Ethics committee country [1]
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Date submitted for ethics approval [1]
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14/11/2007
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Approval date [1]
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Ethics approval number [1]
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Summary
Brief summary
Cardiac surgery triggers an acute inflammatory response throughout the body that contributes to multiple organ failures. How this inflammatory response causes organ failures is not well understood. We have undertaken trials that demonstrate the formation of clots in small blood vessels (capillaries) maybe an important mechnanism.We would like to further investigate this mechanism of organ injury by studying the capillaries in the back of the eye (retina) to see if clots form there following cardiac surgery. Unlike other parts of the body the capillaries of the retina can be seen using fundoscopy ( a special torch that focuses light on the retina). We will use a fundoscopic camera to take pictures of the retina before and after cardiac surgery to asses the changes in the capillaries. Taking pictures of the back of the eye will not expose patients to any risks. The results of this trial may highlight a new and important mechanism of organ injury in inflammatory states.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Eilis Condon
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Address
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St Vincents Hospital
Victoria Parade
Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 92884420
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Fax
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Email
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eilis.condon@svhm.org.au
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Contact person for scientific queries
Name
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Eilis Condon
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Address
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St Vincents Hospital
Victoria Parade
Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 92884420
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Fax
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Email
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eilis.condon@svhm.org.au
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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.
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