Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000278831
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
12/03/2021
Date last updated
12/03/2021
Date data sharing statement initially provided
12/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does mammary artery inflow improve graft patency in Coronary Artery Bypass ?
Scientific title
Does mammary artery inflow affect long-term graft patency and freedom from cardiovascular death in patients undergoing Coronary Artery Bypass ?
Secondary ID [1] 303412 0
Nil known
Universal Trial Number (UTN)
U1111-1264-8409
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 320701 0
Condition category
Condition code
Cardiovascular 318546 318546 0 0
Coronary heart disease
Surgery 318857 318857 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cardiac surgeon will perform 'on-pump' coronary artery bypass surgery for all patients, this procedure takes approximately 3-4.5 hours, . Patients undergoing isolated coronary artery bypass surgery are suitable. All patients included in the study (both intervention and control) will receive a left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft. The intervention group will receive conduit inflow from the right internal mammary artery (RIMA) as an extension/composite graft to supply the largest "non-LAD" coronary territory. The procedure for patients in the intervention arm is expected to take approximately 15 minutes longer to permit harvesting a short segment of the right internal mammary artery (RIMA).

Adherence to protocol intervention will be determined through contemporaneous data entry by the treating team with control-checking by independent researcher audit of surgeons operative notes.

Intervention code [1] 319715 0
Treatment: Surgery
Comparator / control treatment
Patients undergoing isolated 'on-pump' CABG will receive a conventional configuration of coronary artery bypass grafts with a LIMA-to-LAD and standard aorto-coronary anastomosis ('aortic top-end') as conduit inflow for the remaining grafts. The duration of coronary artery bypass surgery is 3-4.5 hours dependant on the number of grafts.
Control group
Active

Outcomes
Primary outcome [1] 326510 0
Composite outcome of graft occlusion and freedom from cardiovascular death with IMA or aortic inflow.

Outcomes are to be assessed with telephone follow-up, medical record review and outcomes of pre-planned interval CT coronary angiography
Timepoint [1] 326510 0
Patients will be followed up at 1 year, 5 years and 10 years with a telephone call and CT coronary angiography to be performed at these time points.
Secondary outcome [1] 391728 0
Freedom from major adverse cardiac and cerebrovascular events
Timepoint [1] 391728 0
Patients will be followed up at 1 year, 5 years and 10 years with a telephone call and review of appropriate medical records.

Eligibility
Key inclusion criteria
Adult patients undergoing isolated coronary artery bypass surgery
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
< 40 years old
Non-English language speaking
Unable to consent for medical procedures unassisted
Contra-indication to either arm of the Protocol (e.g. porcelain aorta, previous saphenous vein ablation, mediastinal radiation etc)
Previous cardiac or thoracic surgery

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)
Sealed opaque letters
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using random computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Survival analysis performed with Kaplan-Meier plots and hazard ratios from Cox regression model

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/03/2021
Actual
Date of last participant enrolment
Anticipated
22/03/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18689 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 33126 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 307827 0
Charities/Societies/Foundations
Name [1] 307827 0
Heart Research Australia
Country [1] 307827 0
Australia
Primary sponsor type
Individual
Name
Dr Levi Bassin
Address
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 308536 0
Individual
Name [1] 308536 0
Dr David Bell
Address [1] 308536 0
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Country [1] 308536 0
Australia
Secondary sponsor category [2] 308539 0
Individual
Name [2] 308539 0
Dr Campbell Flynn
Address [2] 308539 0
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Country [2] 308539 0
Australia
Other collaborator category [1] 281650 0
Individual
Name [1] 281650 0
Dr David Marshman
Address [1] 281650 0
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Country [1] 281650 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307832 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 307832 0
Level 13
Kolling Building
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Ethics committee country [1] 307832 0
Australia
Date submitted for ethics approval [1] 307832 0
19/09/2018
Approval date [1] 307832 0
08/10/2018
Ethics approval number [1] 307832 0
AU/1/B3A738

Summary
Brief summary
The aim of this project is to investigate whether or not using the right internal mammary artery (rather than the ascending aorta) as a source of blood inflow for coronary artery bypass graft surgery (CABG) results in superior long term graft patency. CABG has been shown to be the most durable method of myocardial revascularisation. Efforts to further extend the long-term benefits of CABG have mainly focussed primarily on improving graft patency rates by using arterial grafts. Less attention has been paid to graft haemodynamics, particularly the source of graft inflow, and the role that this may play in prolonging graft patency. We know that high wall sheer stress leads to graft failure and we believe that gentler mammary artery inflow may encourage improved graft harm-dynamics and therefore patency. We plan to randomise patients undergoing CABG to standard practice (which involves using the ascending aorta as inflow) or to a composite graft group (using the right internal mammary artery as inflow) in order to assess whether or not graft inflow affects patency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108662 0
Dr Levi Bassin
Address 108662 0
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Country 108662 0
Australia
Phone 108662 0
+61 2 9449 1559
Fax 108662 0
Email 108662 0
drlevibassin@gmail.com
Contact person for public queries
Name 108663 0
Dr Campbell Flynn
Address 108663 0
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Country 108663 0
Australia
Phone 108663 0
+61 299267111
Fax 108663 0
Email 108663 0
campbellf@doctors.org.uk
Contact person for scientific queries
Name 108664 0
Dr Campbell Flynn
Address 108664 0
Royal North Shore Hospital
4 Westbourne Street
St Leonards NSW 2065
Country 108664 0
Australia
Phone 108664 0
+61 299267111
Fax 108664 0
Email 108664 0
campbellf@doctors.org.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient data not to be shared as per ethics committee approval stipulations


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.