Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001115426p
Ethics application status
Not yet submitted
Date submitted
12/07/2016
Date registered
17/08/2016
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sensitivity of using intraoperative ultrasound using MiraQTM for the assessment of graft patency following coronary artery bypass graft (CABG) surgery, and the effect of ischaemic preconditioning on these measurements - a feasibility study for the SCORECARD project.
Scientific title
Determining Endpoints that are Sensitive to Ischaemia and Graft NarrowING for (DESIGNING) The Sildenafil during Coronary artery bypass graft (CABG) Operations to Reduce Endpoints for patients with Coronary ARtery Disease (SCORECARD) Project
Secondary ID [1] 289651 0
None
Universal Trial Number (UTN)
U1111-1184-9950
Trial acronym
The SCORECARD Project
Linked study record
There is currently no ACTRN number for the linked SCORECARD trial record. DESIGNING The SCORECARD Project is linked to the larger 5-arm study as the data obtained will help our research team as we design Phases II and III of The SCORECARD Project.

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease requiring coronary artery bypass graft surgery 299449 0
Condition category
Condition code
Cardiovascular 299430 299430 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure Group
Patients will have a manual brachial BP cuff applied to the arm not used for routine BP measurement. The BP cuff will be applied by another investigator at the time that median sternotomy is commenced. To induce remote ischaemic preconditioning and to simulate the actions of sildenafil, the cuff will be inflated to 180 mm·Hg for five minutes followed by five minutes of cuff deflation. Each patient will undergo three ten-minute inflation-deflation cycles before removal of the BP cuff and completion of the protocol.
Comparison Group
The BP cuff and sphygmomanometer will be kept with the anaesthetist and out of view of the operating surgeon. To ensure that the operating surgeon is blinded to the participant’s randomisation status, the BP cuff will be inflated (while unattached to the patient and at the time of median sternotomy) by another investigator to 180 mm·Hg for five minutes followed by five minutes of cuff deflation. The process will be repeated for three ten-minute inflation-deflation cycles and then the protocol will be completed.
All Patients
After completion of the anastomosis of the bypass grafts, a MiraQTM Cardiac probe will be introduced into the thoracic cavity and gently placed upon a graft immediately distal to the anastomoses. The procedure will be repeated for each anastomosis undertaken. The probe will be gently manipulated in order to obtain the best ultrasonographic view in consultation with the Responsible Clinician. A SCORECARD Investigator will then record the ultrasound measurements using the MiraQTM Cardiac touch screen. The probe will be gently removed from the thoracic cavity and the entire MiraQTM Cardiac Unit will be moved away from the operating field.
Steps to be taken if there is Clinical Evidence of a Complication
In the event that any graft displays a pulsatility index > 5 or a mean graft flow < 20 ·mL·min-1 the surgeon will be informed so that he can decide whether review of the graft(s) is required. These steps are in keeping with the current NICE Guidelines.
Adherence
There will be no strategies used to monitor adherence because a small sample size is being employed in this study.
Intervention code [1] 295274 0
Treatment: Other
Intervention code [2] 295275 0
Prevention
Comparator / control treatment
Omission of remote ischaemic preconditioning (simulated preconditioning effects of sildenafil) using intraoperative BP cuff inflation. Comparison group participants will nevertheless undergo subsequent intraoperative transit time flow measurement of bypass grafts.
Control group
Active

Outcomes
Primary outcome [1] 298897 0
Pulsatility index obtained using the MiraQ(TM) Cardiac (Medistim, Oslow, Norway) system.
Timepoint [1] 298897 0
Continuous monitoring for up to two minutes immediately following anastomosis of bypass graft(s)
Primary outcome [2] 299281 0
Flow-rate of each graft obtained using the MiraQ(TM) Cardiac (Medistim, Oslow, Norway) system.
Timepoint [2] 299281 0
Continuous monitoring for up to two minutes immediately following anastomosis of bypass graft(s)
Primary outcome [3] 299282 0
Diastolic filling percentage obtained using the MiraQ(TM) Cardiac (Medistim, Oslow, Norway) system.
Timepoint [3] 299282 0
Continuous monitoring for up to two minutes immediately following anastomosis of bypass graft(s)
Secondary outcome [1] 326717 0
Mortality-rate
Timepoint [1] 326717 0
Percentage of all trial patients who die within the 30 day-period immediately following bypass graft surgery
Secondary outcome [2] 326718 0
Serum Troponin T level performed according to local guidelines at LabPLUS - Chemical Pathology Department.
Timepoint [2] 326718 0
Measurement of Troponin T in ng/L at 2,4,8,12,18,24 and 48 hours post-coronary artery bypass graft surgery

Eligibility
Key inclusion criteria
Patients will be eligible for recruitment if they meet all of the following inclusion criteria:
(1) age greater than or equal to 18 years.
(2) Admission to the cardiothoracic surgical unit (Auckland District Health Board, NZ) and expected coronary artery bypass graft surgery between 14 August 2016 and 14 October 2016.
(3) Recommended and offered elective coronary artery bypass graft surgery.
(4) Operating surgeon is the surgeon listed as an Investigator in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible for recruitment if they meet any of the following exclusion criteria:
(1) Creatinine clearance less than or equal to 30 mL per minute.
(2) Hepatic failure as determined by Child-Pugh class B or C.
(3) BP less than or equal to 90/50 mm Hg.
(4) Undergoing coronary artery bypass graft surgery revision.
(5) Unable to provide informed consent.
(6) Not eligible for public funding.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the 'Randomisation Coordinator' who is at a Central Administrative location and does not have contact with the participant. The Randomisation Coordinator randomises the participant and then provides their allocation status within an opaque, sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Not applicable. This is a feasibility study in order to primarily determine, for ourselves, the practicalities of using the MiraQ(TM) Cardiac system, which is recommended by the National Institute of Health and Clinical Excellence (Medical Technology Guidance 8).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Elected to withdraw.
Date of first participant enrolment
Anticipated
14/09/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/10/2016
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 8023 0
New Zealand
State/province [1] 8023 0
Auckland

Funding & Sponsors
Funding source category [1] 294036 0
University
Name [1] 294036 0
University of Auckland
Country [1] 294036 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Anaesthesiology
University of Auckland
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292857 0
None
Name [1] 292857 0
None
Address [1] 292857 0
None
Country [1] 292857 0
Other collaborator category [1] 279074 0
Government body
Name [1] 279074 0
Auckland District Health Board
Address [1] 279074 0
Cardiothoracic Surgical Unit
Auckland City Hospital
Auckland District Health Board
Park Road
Grafton
Auckland 1023
New Zealand
Country [1] 279074 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295449 0
Health and Disability Ethics Committee
Ethics committee address [1] 295449 0
Health and Disability Ethics Committee
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295449 0
New Zealand
Date submitted for ethics approval [1] 295449 0
25/08/2016
Approval date [1] 295449 0
Ethics approval number [1] 295449 0

Summary
Brief summary
The gold-standard treatment for people with critical narrowing (stenosis) of the vessels that supply blood to the heart muscle is coronary artery bypass graft surgery (CABG). CABG involves using conduit vessels harvested from other areas of the body to bypass the areas of critical stenosis. Constriction or blockage of the conduits are complications that commonly affect patients and increase the risk of heart attacks, repeat operations and death.

We have hypothesised that the drug sildenafil may reduce the risk of conduit constriction or blockage. However, before a large scale trial can be undertaken, a critically appraised study protocol must be designed. A sensitive and feasible primary endpoint for this future study is yet to be identified. It is the main purpose of this feasibility study to identify such an endpoint.

The MiraQ Cardiac system uses ultrasound to measure conduit patency in CABG patients and has been shown to be useful in detecting vessel constriction or blockage during CABG. It is possible that measurements of graft patency using the MiraQ Cardiac Unit could provide the sensitive and feasible primary endpoint that we have yet to establish for our future large scale study.

The purpose of this feasibility study is thus: firstly, to determine the practicalities of MiraQ Cardiac-use during CABG; Secondly, to investigate whether measurement of conduit patency could be a sensitive and feasible primary endpoint in a future large-scale study; Lastly, whether the use of the MiraQ Cardiac technology can detect a difference in graft patency for patients who undergo a protocol simulating sildenafil's properties by repeat blood pressure cuff inflation and deflation during CABG.
Trial website
None
Trial related presentations / publications
None
Public notes
None
Attachments [1] 955 955 0 0
/AnzctrAttachments/371069-14.3 Participant Information Sheet v3 (SW).pdf
Attachments [2] 956 956 0 0
/AnzctrAttachments/371069-14.4 Informed Consent Sheet v3 (SW).pdf

Contacts
Principal investigator
Name 67334 0
Dr Steve Waqanivavalagi
Address 67334 0
Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142
Country 67334 0
New Zealand
Phone 67334 0
+64275370425
Fax 67334 0
None
Email 67334 0
[email protected]
Contact person for public queries
Name 67335 0
Dr Steve Waqanivavalagi
Address 67335 0
Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142
Country 67335 0
New Zealand
Phone 67335 0
+64275370425
Fax 67335 0
None
Email 67335 0
[email protected]
Contact person for scientific queries
Name 67336 0
Dr Steve Waqanivavalagi
Address 67336 0
Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142
Country 67336 0
New Zealand
Phone 67336 0
+64 27 537 0425
Fax 67336 0
None
Email 67336 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.