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Trial registered on ANZCTR


Registration number
ACTRN12617000944336
Ethics application status
Approved
Date submitted
16/06/2017
Date registered
30/06/2017
Date last updated
26/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Assessment of Coronary artery disease using Computed tomography Effectively for Stable Symptoms (ACCESS): Field Testing the ACCESS Tool
Scientific title
The Assessment of Coronary artery disease using Computed tomography Effectively for Stable Symptoms (ACCESS): Field Testing the ACCESS Tool
Secondary ID [1] 292112 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACCESS-Field Testing
Linked study record
CADOSA-Registry
ACTRN12615000026527

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 303535 0
Chest Pain 303536 0
Coronary Angiography 303537 0
Coronary Computed Tomography Angiogram 303538 0
Condition category
Condition code
Cardiovascular 302945 302945 0 0
Coronary heart disease
Public Health 302946 302946 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 298259 0
Not applicable
Comparator / control treatment
The result of the ACCESS Tool algorithm will be compared to the observed ICA findings.
Control group
Active

Outcomes
Primary outcome [1] 302343 0
The predictive ability of the ACCESS Tool to accurately identify patients with normal coronary angiography (stenosis <50%) prior to elective ICA as per comparison with the ICA results.
Timepoint [1] 302343 0
During hospital admission for procedure.
Secondary outcome [1] 335601 0
Coronary artery disease of stenosis <70% as shown on elective ICA.
Timepoint [1] 335601 0
During hospital admission for procedure.
Secondary outcome [2] 335820 0
Coronary artery disease of stenosis <20% as shown on elective ICA.
Timepoint [2] 335820 0
During hospital admission for procedure.
Secondary outcome [3] 335821 0
A change in medical therapy due to the results of the elective ICA as documented in the medical record.
Timepoint [3] 335821 0
During hospital admission for procedure.

Eligibility
Key inclusion criteria
Referred for elective invasive coronary angiogram at The Queen Elizabeth Hospital (TQEH) or the Royal Adelaide Hospital (RAH).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with known history of coronary artery disease (i.e. previous myocardial infarction, PCI or coronary artery bypass grafting.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
At the conclusion of the Field Testing, we will undertake further validation of the ACCESS Tool using the data obtained during the Field Testing. A logistic regression model will assess the individual relationship between each variable collected and the ICA outcome (CAD present/absent). A multivariable stepwise logistic regression (backward elimination) approach will be used to estimate the probability of the ICA outcome and variables associated with p<0.05 retained in the final, validated model of the ACCESS Tool. The goodness of fit of the final model will be evaluated using the Hosmer Lemeshow goodness of fit test. The discriminatory capacity of the ACCESS Tool will be assessed by using the area under the receiver operating characteristic curve (c statistic) as an index of model performance. The c-statistic reflects the concordance of predictions with actual outcomes in rank order, with a c statistic of 1.0 indicating perfect discrimination. In addition to ROC, the sensitivity, specificity, negative and positive predictive values of the ACCESS Tool will be assessed. Accuracy of calibration will also be evaluated by plotting the predicted versus observed outcome. Once confirmed that the ACCESS Tool can perform well in a real-world setting (i.e. a sensitivity of > 80% with a moderate-high AUC), the ACCESS Tool will be ready for use in the ACCESS Clinical Trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2017
Actual
16/08/2017
Date of last participant enrolment
Anticipated
31/12/2017
Actual
15/06/2018
Date of last data collection
Anticipated
31/12/2017
Actual
15/06/2018
Sample size
Target
880
Accrual to date
Final
887
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8240 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 8241 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16300 0
5000 - Adelaide
Recruitment postcode(s) [2] 16299 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 296648 0
Government body
Name [1] 296648 0
NHMRC Partnership Projects Grants
Country [1] 296648 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
University of Adelaide- The Queen Elizabeth Hospital campus
Level 5B - Dept of Medicine,
28 Woodville Road
Woodville South
SA 5011
Country
Australia
Secondary sponsor category [1] 295609 0
None
Name [1] 295609 0
Address [1] 295609 0
Country [1] 295609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297875 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 297875 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Ethics committee country [1] 297875 0
Australia
Date submitted for ethics approval [1] 297875 0
27/11/2015
Approval date [1] 297875 0
04/01/2016
Ethics approval number [1] 297875 0
HREC/15/TQEH/266

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75338 0
Prof John Beltrame
Address 75338 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 75338 0
Australia
Phone 75338 0
+61 8 82226740
Fax 75338 0
Email 75338 0
john.beltrame@adelaide.edu.au
Contact person for public queries
Name 75339 0
Rosanna Tavella
Address 75339 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 75339 0
Australia
Phone 75339 0
+61 8 81334011
Fax 75339 0
Email 75339 0
rosanna.tavella@adelaide.edu.au
Contact person for scientific queries
Name 75340 0
Rosanna Tavella
Address 75340 0
The University of Adelaide
Discipline of Medicine
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 75340 0
Australia
Phone 75340 0
+61 8 81334011
Fax 75340 0
Email 75340 0
rosanna.tavella@adelaide.edu.au

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No Supporting Document Provided



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