The Assessment of Coronary artery disease using Computed tomography Effectively for Stable Symptoms (ACCESS): Field Testing the ACCESS Tool

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617000944336

Acronym

ACCESS-Field Testing

Enrollment

887

Registered

2017-06-30

Start date

2017-08-16

Completion date

2018-06-15

Last updated

2018-07-02

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

Conditions

None listed

Brief summary

Invasive coronary angiography is the benchmark investigation for Coronary Artery Disease (CAD) with approximately 6,000 performed in South Australian public hospitals each year. The ACCESS Program (The Assessment of Coronary artery disease using Computed tomography Effectively for Stable Symptoms) is a large project involving the development and application of a simple clinical tool to identify which patients are likely to have a normal angiogram amongst those scheduled for elective invasive coronary angiography. These patients can then be alternatively referred for coronary computed tomography angiography, a noninvasive technique that is safer and less expensive than invasive angiography yet has shown to be as reliable as the benchmark test in confirming the presence of normal coronary arteries. The ACCESS Tool has been retrospectively developed from a local cardiac procedures registry (CADOSA – Coronary Angiogram Database of South Australia) using statistical modeling techniques to pre-procedurally identify patients with a high probability of normal coronary angiography. To asses the effectiveness of this Tool in clinical practice, it is important to ‘field test’ the ACCESS Tool prospectively as its utility may change when being by applied by hospital staff in a real-world setting. This current protocol refers to the Field Testing of the ACCESS Tool, whereby for a 3-month period, hospital staff will apply the ACCESS Tool to patients booked for elective angiography via a short phonecall. The outcome of the ACCESS Tool will be recorded and compared to the angiography findings. The sensitivity, specificity and receiver operator characteristics of the ACCESS Tool in practice will then be evaluated in preparation for a clinical trial.

Interventions

This is a prospective, observational, multi-site study of patients scheduled for elective Invasive Coronary Angiogram (ICA). Staff will apply the ACCESS Tool for patients booked for elective ICA at either the Royal Adelaide Hospital or The Queen Elizabeth Hospital. The ACCESS Tool is a statistical algorithm which was developed from data obtained from the CADOSA-Registry (ACRTN125000026527). The process involves obtaining key information from the patient, e.g. past history, current symptoms, etc using a series of set questions. The patient’s responses to the questions are entered into the statistical algorithm by the research staff in order to calculate the patient’s probability of normal angiography. This will be done by phone within the week prior to the procedure or in person on the day of the procedure. The result of the statistical algorithm will be compared with the observed ICA findings. Each patient will only be observed during the hospital admission for the procedure, with no further follow-up required.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Referred for elective invasive coronary angiogram at The Queen Elizabeth Hospital (TQEH) or the Royal Adelaide Hospital (RAH).

Exclusion criteria

Those with known history of coronary artery disease (i.e. previous myocardial infarction, PCI or coronary artery bypass grafting.

Outcome results