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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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001114437
Acronym
AUDITED Numbers
Enrollment
250
Registered
2016-08-17
Start date
2016-09-01
Completion date
2016-10-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

University of Auckland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) Underwent coronary artery bypass graft surgery. 2) Procedure between 1 August 2015 and 31 July 2016.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026