Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000257864
Ethics application status
Approved
Date submitted
11/12/2020
Date registered
10/03/2021
Date last updated
6/07/2024
Date data sharing statement initially provided
10/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Graft Patency and Clinical Outcomes Following Coronary Artery Bypass Grafting with Instrumented Radial Arteries
Scientific title
Graft Patency and Clinical Outcomes Following Coronary Artery Bypass Grafting with Instrumented Radial Arteries
Secondary ID [1] 302572 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
 319450 0
Coronary artery bypass grafting 319451 0
Intrumented radial arteries 319453 0
Condition category
Condition code
Cardiovascular 317422 317422 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study has two aims:
1. To evaluate the patency of instrumented radial arteries used for CABG, compared to non-instrumented radial arteries.
2. To evaluate the clinical outcomes of patients undergoing CABG with an instrumented radial artery, compared to those without an instrumented radial artery.

Initially, patients will be recruited from the hospitals cardiac surgery database. Patients in the database who underwent surgery between January 2015 and December 2019 will be reviewed. Only those patients who had coronary artery bypass grafting with bilateral radial arteries will be included. For eligible patients, baseline data will be collected retrospectively from the hospital medical records and the hospital cardiac surgery database. Further data may be retrieved from other medical practitioners involved in their care. Information collected includes medical history, investigation results, pre-operative data, operation records, post operative data and longer term outcomes (see below for specific outcome data). Following review of the medical records, patients will be telephoned to seek clarification and further information as required. This will be a one off phone call, and will include facilitating completion of a Seattle Angina Questionnaire (short form, SAQ-7).

The second part of the study, known as "patency follow up", involves conducting CT-coronary angiograms on a specific subset of patients. These patients are those who have an instrumented radial artery used as a coronary artery bypass graft. During the above "clinical follow up" phone call, patients will be assessed as to whether they are eligible for the "patency follow up" arm of the study. Eligible patients (see inclusion and exclusion criteria elsewhere in this document) will undergo a CT-coronary angiogram to evaluate the patency of the coronary artery bypass grafts. If eligible and willing to participate, patients will expect to undergo the CT-coronary angiogram within approximately 6-weeks. This scan will occur in Heidelberg, Victoria at I-MED Warringal and it is expected that the participant would require to be present for 1.5 - 2 hours duration.
Intervention code [1] 318862 0
Not applicable
Comparator / control treatment
Aim 1: The comparator to the instrumented radial artery graft will be the contralateral non-instrumented radial artery graft,
Aim 2: The comparator group is those without an instrumented radial artery.
Control group
Active

Outcomes
Primary outcome [1] 325457 0
Aim 1 (patency follow up): Patency (or graft failure rate) of the instrumented radial artery grafts, compared to the non-instrumented radial artery graft.
- Patients in the study cohort who had an instrumented radial artery used as a graft will be eligbile for this part of the study.
- Each instrumented radial graft will be assessed by CT-coronary angiography (CTCA) by two certified CTCA readers, both blinded to the location of the instrumented RA. Graft stenoses will be assessed as per the CAD-RADS stenosis guidelines (0% stenosis, 1-24% stenosis, 25-49% stenosis, 50-69% stenosis, 70-99% stenosis, or occluded) and whether "string sign" is present.
- Graft patency will be defined as the absence of string sign, occlusion, or stenosis 70% or more. That is, graft failure is defined as total occlusion, stenosis of 70% or more, or string sign.
Timepoint [1] 325457 0
Aim 1 (patency follow up):
- Patients will undergo CT-coronary angiography at varying time points. Patients will be followed up at least one year following CABG, with a range of 1-5 years. Each patient will undergo one CT-coronary angiogram. The mean mean follow up is anticipated to be approximately 2.5-3 years.
Primary outcome [2] 325458 0
Aim 2 (clinical follow up): - Composite outcome: all-cause mortality, non-fatal myocardial infarction, repeat revascularization,

This outcome will be assessed by review of medical records and phone call to participating patients. Verification of history and further clinical information may be retrieved from treating medical professionals following consent.
Timepoint [2] 325458 0
Aim 2 (clinical follow up):
- Clinical follow up will be assessed both at 12 months, and at longest available follow up.
Secondary outcome [1] 389808 0
Aim 2 (clinical follow up):
- Symptom / angina status. This will be assessed via two different assessment tools;
- Patient assessed - Using the Seattle Angina Questionnaire Short Form (SQQ-7).
- Clinican assessed - Canadian Cardiovascular Society (CCS) angina grade.
Timepoint [1] 389808 0
Aim 2 (clinical follow up):
- at time of follow up (between 1 and 5 years post surgery)
Secondary outcome [2] 391614 0
Aim 2 (clinical follow up):
- Non-fatal stroke. This will be assessed via phone call with the participant, and verified via hospital medical records, as able.
Timepoint [2] 391614 0
12 months and longest available follow up
Secondary outcome [3] 391616 0
Aim 2 (clinical follow up):
- All-cause mortality
- This will be assessed via phone call with the participant, and verified via hospital medical records, as able.
Timepoint [3] 391616 0
At 12 months and at longest available follow up
Secondary outcome [4] 392625 0
Aim 2 (clinical follow up):
- non-fatal myocardial infarction.
- This will be assessed via phone call with the participant, and verified via hospital medical records, as able.
Timepoint [4] 392625 0
At 12 months and at longest available follow up
Secondary outcome [5] 392626 0
Aim 2 (clinical follow up):
- Repeat revascularisation.
- This will be assessed via phone call with the participant, and verified via hospital medical records, as able.
Timepoint [5] 392626 0
At 12 months and longest available follow up.
Secondary outcome [6] 420903 0
Angiographoc characteristics of instrumented radial arteries compared to non-instrumented radial arteries. This will include whether the grafts are angiographically clean / smooth, the vessel diameter/cross sectional area (proximally, distally and in the mid segment), and graft runoff in native vessel. This will be assessed on the CT coronary angiogram.
Timepoint [6] 420903 0
The timepoint is relative to the time since index CABG when CT scan is performed. This will be at least 1-year, and up to 5-years. The mean follow up duration (time since surgery) is anticipated to be approximately 3-4 years.

Eligibility
Key inclusion criteria
Whole study:
Adult patients aged 18 years or older who underwent coronary artery bypass grafting between 2015-2019 using bilateral radial arteries as conduits.

For the Patency arm of the study (Aim 1):
Patients who underwent CABG with an instrumented radial artery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patency follow up (Aim 1)
- Stage 4 or more chronic kidney disease.
- Patients who have had either an invasive coronary angiogram or CT coronary angiogram following surgery.
- The CABG operation record does not specify the location of each radial artery (ie which RA is grafted to which native vessel).
- Allergy to contrast agent.
- Unable to sufficiently control heart rate to perform scan or contraindication to metoprolol administration if required

Clinical follow up (Aim 2)
- Unable to provide consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Analysis will be using a mixed effect logistic regression model for patency follow up (aim 1), and a logistic regression model for clinical follow up (aim 2). Clinical follow up will be analysed at 12-months, and at longest available follow up by time to event analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2021
Actual
1/09/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
10/08/2022
Date of last data collection
Anticipated
10/05/2023
Actual
28/02/2023
Sample size
Target
300
Accrual to date
Final
294
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17850 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 31707 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 307004 0
Charities/Societies/Foundations
Name [1] 307004 0
Austin Medical Research Foundation
Country [1] 307004 0
Australia
Primary sponsor type
Individual
Name
A/Prof Omar Farouque
Address
Austin Health
145 Studley Rd
Heidelberg
Victoria. 3084
Country
Australia
Secondary sponsor category [1] 307577 0
None
Name [1] 307577 0
Address [1] 307577 0
Country [1] 307577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307136 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 307136 0
Ethics committee country [1] 307136 0
Australia
Date submitted for ethics approval [1] 307136 0
31/08/2020
Approval date [1] 307136 0
19/02/2021
Ethics approval number [1] 307136 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106158 0
A/Prof Omar Farouque
Address 106158 0
Department of Cardiology
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
Country 106158 0
Australia
Phone 106158 0
+61 03 9496 3034
Fax 106158 0
Email 106158 0
[email protected]
Contact person for public queries
Name 106159 0
Garry Hamilton
Address 106159 0
Department of Cardiology
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
Country 106159 0
Australia
Phone 106159 0
+61 03 9496 5000
Fax 106159 0
Email 106159 0
[email protected]
Contact person for scientific queries
Name 106160 0
Garry Hamilton
Address 106160 0
Department of Cardiology
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
Country 106160 0
Australia
Phone 106160 0
+61 03 9496 5000
Fax 106160 0
Email 106160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.