Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001114437p
Ethics application status
Submitted, not yet approved
Date submitted
14/08/2016
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
Analysing and Using Demographic Information and Treatment Endpoints to Determine Numbers (AUDITED Numbers) for The Sildenafil during Coronary artery bypass graft Operations to Reduce Endpoints for patients with Coronary ARtery Disease (SCORECARD) Project
Scientific title
Analysing and Using Demographic Information and Treatment Endpoints to Determine Numbers (AUDITED Numbers) for The Sildenafil during Coronary artery bypass graft Operations to Reduce Endpoints for patients with Coronary ARtery Disease (SCORECARD) Project
Secondary ID [1] 289931 0
None
Universal Trial Number (UTN)
U1111-1186-4611
Trial acronym
AUDITED Numbers
Linked study record
There is currently no ACTRN number for the linked SCORECARD Project record. AUDITED Numbers will help define the population size and the occurrence rate of short-term outcomes for a future Phase II study, both of which are two components of the five-arm SCORECARD Project.

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 299904 0
Condition category
Condition code
Cardiovascular 299806 299806 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
Retrospective analysis of the clinical notes of all patients who underwent coronary artery bypass graft surgery at Greenlane Cardiothoracic Surgical Unit between 1 August 2015 and 31 July 2016.
Intervention code [1] 295612 0
Not applicable
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299279 0
Diagnosed myocardial infarction based upon review of the patient's anaesthetic record, Cardiovascular Intensive Care Unit record and discharge summary from the cardiothoracic service.
Timepoint [1] 299279 0
Within 30 days post-coronary artery bypass graft surgery
Secondary outcome [1] 326709 0
Diagnosed vasospasm based upon review of the patient's anaesthetic record, Cardiovascular Intensive Care Unit record and discharge summary from the cardiothoracic service.
Timepoint [1] 326709 0
Within 30 days post-coronary artery bypass graft surgery based upon review of the patient's anaesthetic record, Cardiovascular Intensive Care Unit record and discharge summary from the cardiothoracic service.
Secondary outcome [2] 326710 0
Diagnosed graft failure based upon review of the patient's anaesthetic record, Cardiovascular Intensive Care Unit record and discharge summary from the cardiothoracic service.
Timepoint [2] 326710 0
Within 30 days post-coronary artery bypass graft surgery
Secondary outcome [3] 326711 0
Mortality-rate
Timepoint [3] 326711 0
At 30 days post-coronary artery bypass graft surgery
Secondary outcome [4] 326712 0
Diagnosed acute kidney injury based upon review of the patient's anaesthetic record, Cardiovascular Intensive Care Unit record and discharge summary from the cardiothoracic service.
Timepoint [4] 326712 0
Within 30 days post-coronary artery bypass graft surgery
Secondary outcome [5] 326713 0
Repeat revascularisation procedure based upon review of the patient's anaesthetic record, Cardiovascular Intensive Care Unit record and discharge summary from the cardiothoracic service.
Timepoint [5] 326713 0
Within 30 days post-coronary artery bypass graft surgery
Secondary outcome [6] 326714 0
Duration of intubation based upon review of the patient's anaesthetic record and Cardiovascular Intensive Care Unit record.
Timepoint [6] 326714 0
At time of extubation
Secondary outcome [7] 326715 0
Duration of Cardiovascular Intensive Care Unit stay based upon review of the patient's Cardiovascular Intensive Care Unit record.
Timepoint [7] 326715 0
Time of discharge from Cardiovascular Intensive Care Unit
Secondary outcome [8] 326716 0
Duration of admission based upon review of the patient's discharge summary from the cardiothoracic service.
Timepoint [8] 326716 0
Time of discharge from hospital

Eligibility
Key inclusion criteria
1) Underwent coronary artery bypass graft surgery.
2) Procedure between 1 August 2015 and 31 July 2016.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
This retrospective analysis of all patients undergoing coronary artery bypass graft surgery at Greenlane Cardiothoracic Surgical Unit within a 12-month period will provide a snapshot of the mean intraoperative and postoperative characteristics of patients such as the average duration of intubation. This analysis will also provide a snapshot of the short-term (30 days) morbidity- and mortality-rates of coronary artery bypass graft surgery patients.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Elected to withdraw study.
Date of first participant enrolment
Anticipated
1/09/2016
Actual
Date of last participant enrolment
Anticipated
28/10/2016
Actual
Date of last data collection
Anticipated
28/10/2016
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 8098 0
New Zealand
State/province [1] 8098 0
Auckland

Funding & Sponsors
Funding source category [1] 294304 0
University
Name [1] 294304 0
University of Auckland
Country [1] 294304 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293144 0
None
Name [1] 293144 0
Address [1] 293144 0
Country [1] 293144 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295731 0
Health and Disability Ethics Committee
Ethics committee address [1] 295731 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295731 0
New Zealand
Date submitted for ethics approval [1] 295731 0
27/07/2016
Approval date [1] 295731 0
Ethics approval number [1] 295731 0

Summary
Brief summary
Rationale of Study
As described in detail elsewhere, cardiovascular disease is the greatest cause of mortality in New Zealand. Coronary artery disease (CAD) is not only implicated in most of these patients but is also the commonest cause of death, worldwide. In patients with severe CAD, the gold-standard revascularisation approach is CABG which, in low-risk patients, carries a mortality risk of < 1%. Furthermore, the success-rates of CABG have increased substantially over the last several decades as a result of improvements in surgical technique and the development of an increasingly robust literature-base. However, major adverse cardiac events still affect around 5% of patients and they are potently associated with the incidence of vasospasm, graft occlusion and ischaemia-reperfusion injury. Therefore, the continued development and refinement of methods to reduce these complications has the potential to significantly improve CABG outcomes.
A variety of techniques are presently employed to reduce vasospasm and graft occlusion. For example, the use of the ‘no-touch’ technique during graft harvesting significantly reduces vasospasm and the intraluminal administration of a nitroglycerin-verapamil solution reduces the risk of graft occlusion. However, these approaches are not foolproof. Every graft requires at least some degree of physical contact during anastomosis and the nitroglycerin-verapamil solution is limited by its short half-life and marked systemic effects. Ischaemia-reperfusion injury is also a relatively new concept and, while clinical studies investigating the therapeutic effect of remote ischaemic preconditioning have been successful, routine use in the operating theatre remains scarce.
Sildenafil is a type 5 phosphodiesterase inhibitor that has vasodilatory, antiplatelet and ischaemia-reperfusion injury-preventing properties. Thus, it has been suggested that sildenafil might have novel therapeutic effects in patients undergoing CABG. A double-blind randomised controlled trial is currently being designed in order to investigate this hypothesis. However, it is unknown exactly what proportion of patients undergoing CABG within the Auckland region suffer from short-term vasospasm, graft occlusion and ischaemia-reperfusion injury or which demographic groups are over-represented in patients undergoing CABG. Therefore, the purpose of this study is to determine the demographic makeup and vasospasm, graft occlusion and ischaemia reperfusion-injury complication-rates in patients undergoing CABG within the greater Auckland region.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 68246 0
Dr Steve Waqanivavalagi
Address 68246 0
Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142
Country 68246 0
New Zealand
Phone 68246 0
+64275370425
Fax 68246 0
Email 68246 0
[email protected]
Contact person for public queries
Name 68247 0
Dr Steve Waqanivavalagi
Address 68247 0
Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142
Country 68247 0
New Zealand
Phone 68247 0
+64275370425
Fax 68247 0
Email 68247 0
[email protected]
Contact person for scientific queries
Name 68248 0
Dr Steve Waqanivavalagi
Address 68248 0
Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142
Country 68248 0
New Zealand
Phone 68248 0
+64275370425
Fax 68248 0
Email 68248 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.