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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

Secondary ID [1]

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

Condition category

Condition code

Cardiovascular

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]

Not applicable

Comparator / control treatment

Not applicable.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Within 30 days post-coronary artery bypass graft surgery

Secondary outcome [1]

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]

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]

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]

Within 30 days post-coronary artery bypass graft surgery

Secondary outcome [3]

Mortality-rate

Timepoint [3]

At 30 days post-coronary artery bypass graft surgery

Secondary outcome [4]

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]

Within 30 days post-coronary artery bypass graft surgery

Secondary outcome [5]

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]

Within 30 days post-coronary artery bypass graft surgery

Secondary outcome [6]

Duration of intubation based upon review of the patient's anaesthetic record and Cardiovascular Intensive Care Unit record.

Timepoint [6]

At time of extubation

Secondary outcome [7]

Duration of Cardiovascular Intensive Care Unit stay based upon review of the patient's Cardiovascular Intensive Care Unit record.

Timepoint [7]

Time of discharge from Cardiovascular Intensive Care Unit

Secondary outcome [8]

Duration of admission based upon review of the patient's discharge summary from the cardiothoracic service.

Timepoint [8]

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?

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland

Address [1]

Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland 1142

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

27/07/2016

Approval date [1]

Ethics approval number [1]

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

Dr Steve Waqanivavalagi

Address

Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142

Country

New Zealand

Phone

+64275370425

Fax

[email protected]

Contact person for public queries

Name

Steve Waqanivavalagi

Address

Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142

Country

New Zealand

Phone

+64275370425

Fax

[email protected]

Contact person for scientific queries

Name

Steve Waqanivavalagi

Address

Department of Medicine, University of Auckland, Private Bag 92019, Auckland 1142

Country

New Zealand

Phone

+64275370425

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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