Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000135516
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
14/02/2024
Date last updated
14/02/2024
Date data sharing statement initially provided
14/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Integration of Cloud Based Artificial Intelligence Assisted Medical Image and Clinical Data Analysis into Stroke Patient Workflows
Scientific title
Integration of Cloud Based Artificial Intelligence Assisted Medical Image and Clinical Data Analysis into Stroke Patient Workflows
Secondary ID [1] 311215 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Cloud AI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 332406 0
Condition category
Condition code
Stroke 329107 329107 0 0
Haemorrhagic
Stroke 329108 329108 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Develop Artificial Intelligence (AI) Based tools for automatic brain imaging lesion segmentation and measurement. The AI software is integrated into the current medical imaging software used in NSW Health. All radiological images from adult stroke patients will be labelled by the AI software prior to the report formulation to estimate lesion sizes in the acute stroke phase. The images are collected at hospital presentation, 24 hours after admission and on an as-needed basis. Both hemorrhagic and ischemic strokes will be included. All images are collected as part of standard of care at the discretion of the treating medical team. This is an observational study and therefore nothing is required of participants, including follow-up. No blood tests, additional radiological imaging or clinical interventions are required as part of this observational study. The AI software is trained by a neurologist and will be integrated into the radiological imaging report formulated by a radiologist.
Intervention code [1] 327673 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336925 0
Specificity of measurement of lesion volumes by a AI tool
Timepoint [1] 336925 0
7 days post hospital presentation
Secondary outcome [1] 430176 0
Accuracy of patient outcome prediction
Timepoint [1] 430176 0
90 days post hospital presentation

Eligibility
Key inclusion criteria
Patients assessed for possible acute stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients without acute stroke imaging data

Study design
Purpose
Screening
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
Date of last participant enrolment
Anticipated
5/03/2029
Actual
Date of last data collection
Anticipated
5/03/2029
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25955 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 41790 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 315475 0
Government body
Name [1] 315475 0
National Health and Medical Research Council (NHMRC)
Country [1] 315475 0
Australia
Primary sponsor type
Individual
Name
Professor Ken Butcher
Address
Prince of Wales Hospital 320-346 Barker St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 317546 0
None
Name [1] 317546 0
Address [1] 317546 0
Country [1] 317546 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314384 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314384 0
District Executive Unit, Level 4, The Sutherland Hospital & Community Health Service, Cnr Kingsway and Kareena Road, Caringbah NSW 2229
Ethics committee country [1] 314384 0
Australia
Date submitted for ethics approval [1] 314384 0
18/11/2022
Approval date [1] 314384 0
20/02/2023
Ethics approval number [1] 314384 0
2022/ETH02428

Summary
Brief summary
The aim is to use Artificial Intelligence based tools for automated measurement of
lesions/areas of ischemia in stroke patients. This data will be used for patient outcome prediction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131386 0
Prof Ken Butcher
Address 131386 0
Prince of Wales Hospital 320-346 Barker Street, Randwick NSW 2031
Country 131386 0
Australia
Phone 131386 0
+61 29382 8891
Fax 131386 0
Email 131386 0
kenneth.butcher@health.nsw.gov.au
Contact person for public queries
Name 131387 0
Prof Ken Butcher
Address 131387 0
Prince of Wales Hospital 320-346 Barker Street, Randwick NSW 2031
Country 131387 0
Australia
Phone 131387 0
+61 29382 8891
Fax 131387 0
Email 131387 0
kenneth.butcher@health.nsw.gov.au
Contact person for scientific queries
Name 131388 0
Prof Ken Butcher
Address 131388 0
Prince of Wales Hospital 320-346 Barker Street, Randwick NSW 2031
Country 131388 0
Australia
Phone 131388 0
+61 2 9382 8891
Fax 131388 0
Email 131388 0
kenneth.butcher@health.nsw.gov.au

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.