Trial Review

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
ACTRN12609000579291
Ethics application status
Not yet submitted
Date submitted
2/07/2009
Date registered
14/07/2009
Date last updated
14/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of flow reserve in skeletonized versus pedicled internal thoracic arteries during coronary artery bypass surgery?
Scientific title
A comparison of flow reserve in skeletonized versus pedicled internal thoracic arteries during coronary artery bypass surgery?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Internal thoracic artery 237134 0
Condition category
Condition code
Cardiovascular 237457 237457 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients having bilateral internal thoracic artery harvest for coronary bypass will be randomized to having one side dissected pedicled (artery and veins) or skeletonized (artery only) to determine if a method provides superior flow.

Both arms of the study require diathermy dissection of the mammary artery of the chest wall and clipping of the branches of the artery. The two techniques differ as the pedicled approach involves clipping of the branches of both the mammary veins and artery and dissecting the mammary artery and veins en bloc from the chet wall while the skeletonized approach involves only clipping and dissection of branches of the mammary artery only and leaving the mammary veins in situ. Both techniques take approximately 30-40 minutes and both techniques are currently in widespread use.
Intervention code [1] 236851 0
Treatment: Surgery
Comparator / control treatment
Pedicled harvest (artery and veins)
Control group
Active

Outcomes
Primary outcome [1] 238264 0
Arterial Flow
The measurment will be conducted by timing how quickly the flow will fill a 50ml sterile pot.
Timepoint [1] 238264 0
Measured in theatre during operation
Secondary outcome [1] 244629 0
Arterial length
Arterial length will be measured by cutting a a piece of silk sutrure to the same length measuring the artery from the proximal end (marked by the subclavian vein) to its end and then measuring this vicryl with a sterile ruler.
Timepoint [1] 244629 0
Measured in theatre during operation

Eligibility
Key inclusion criteria
Patients undergoing cardiac surgery who require use of bilateral internal thoracic arteries for coronary surgery.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency case
Haemodynamically unstable patient

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients requiring bilateral internal thoracic artery harvest will be asked to participate in the study by a research nurse. Then patient will be consented by a member of the the cardiac surgery research team.
Randomization will be single blinded by a sealed envelope method. Randomization will be performed independently by the cardiac research nurse office and the allocation communicated to the surgeon following opening of the pericardium and confirmation of the suitablility of coronary anatomy for randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237239 0
Hospital
Name [1] 237239 0
Austin Hospital
Country [1] 237239 0
Australia
Primary sponsor type
Individual
Name
Mr Phillip Hayward
Address
Austin Hospital
145 Studley Road
PO Box 5555 Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 236727 0
Individual
Name [1] 236727 0
Dr Jim Dimitriou
Address [1] 236727 0
Austin Hospital
145 Studley Road
PO Box 5555 Heidelberg
Victoria 3084
Country [1] 236727 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239341 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 239341 0
Austin Hospital
Research Ethics Unit
145 Studley Road
PO Box 5555 Heidelberg
Victoria 3084
Ethics committee country [1] 239341 0
Australia
Date submitted for ethics approval [1] 239341 0
02/07/2009
Approval date [1] 239341 0
Ethics approval number [1] 239341 0

Summary
Brief summary
The aim of this project is to determine the best way to harvest an artery that is commonly used in cardiac surgery from behind the chest bone to allow best possible result.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29828 0
Address 29828 0
Country 29828 0
Phone 29828 0
Fax 29828 0
Email 29828 0
Contact person for public queries
Name 13075 0
Dr Jim Dimitriou
Address 13075 0
Austin Hospital
145 Studley Road
PO Box 5555 Heidelberg
Victoria 3084
Country 13075 0
Australia
Phone 13075 0
+61 9496 5453
Fax 13075 0
Email 13075 0
[email protected]
Contact person for scientific queries
Name 4003 0
Mr Phillip Hayward
Address 4003 0
Austin Hospital
145 Studley Road
PO Box 5555 Heidelberg
Victoria 3084
Country 4003 0
Australia
Phone 4003 0
+61 9496 5453
Fax 4003 0
Email 4003 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.