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Trial registered on ANZCTR


Registration number
ACTRN12625000079448
Ethics application status
Approved
Date submitted
12/02/2025
Date registered
12/02/2025
Date last updated
12/02/2025
Date data sharing statement initially provided
12/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
XXTESTFORVIDEOS - 12 Feb 2025 testing for step 11
Scientific title
XXTESTFORVIDEOS
Secondary ID [1] 293844 0
Nil Known
Universal Trial Number (UTN)


Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscoluskeletal 306305 0
cancer 308370 0
Condition category
Condition code
Cancer 311448 311448 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be adults those who have experienced a heart attack within the last 5 years and have been diagnosed with type 2 diabetes.
Participants will need to provide a blood sample every 6 months for 2 years after occurrence of heart attack.

xx
XX
Intervention code [1] 329240 0
Prevention
Comparator / control treatment
Participants who have experienced a heart attack who have not been diagnosed with type 2 diabetes.
Control group
Active

Outcomes
Primary outcome [1] 307277 0
pain
Timepoint [1] 307277 0
6 months
Secondary outcome [1] 351345 0
pain3
Timepoint [1] 351345 0
3 months

Eligibility
Key inclusion criteria
XX
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
XX

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2023
Date of last participant enrolment
Anticipated
Actual
1/08/2023
Date of last data collection
Anticipated
Actual
4/03/2024
Sample size
Target
15
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17064 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 18199 0
St John of God Hospital - Burwood
Recruitment hospital [3] 20346 0
Mark Hinds Optometrists - Teneriffe
Recruitment hospital [4] 20963 0
Southside Cancer Care Centre - Miranda
Recruitment hospital [5] 25065 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [6] 25310 0
Repat Neuro-Behavioural Unit - Daw Park
Recruitment hospital [7] 26388 0
Arcare Aged Care Balnarring - Balnarring
Recruitment hospital [8] 26673 0
Wicking Dementia Research and Education Centre - University of Tasmania - Hobart
Recruitment postcode(s) [1] 30734 0
2050 - Camperdown
Recruitment postcode(s) [2] 32257 0
2134 - Burwood
Recruitment postcode(s) [3] 35108 0
4005 - Teneriffe
Recruitment postcode(s) [4] 35795 0
2228 - Miranda
Recruitment postcode(s) [5] 40728 0
4558 - Maroochydore
Recruitment postcode(s) [6] 40987 0
5041 - Daw Park
Recruitment postcode(s) [7] 42363 0
3926 - Balnarring
Recruitment postcode(s) [8] 42713 0
7000 - Hobart
Recruitment outside Australia
Country [1] 10564 0
New Zealand
State/province [1] 10564 0

Funding & Sponsors
Funding source category [1] 299978 0
Self funded/Unfunded
Name [1] 299978 0
RPAH
Country [1] 299978 0
Australia
Primary sponsor type
Government body
Name
XX
Address
XX
Country
Australia
Secondary sponsor category [1] 308093 0
None
Name [1] 308093 0
Address [1] 308093 0
Country [1] 308093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315140 0
Australian Institute of Family Studies Ethics Committee
Ethics committee address [1] 315140 0
Ethics committee country [1] 315140 0
Australia
Date submitted for ethics approval [1] 315140 0
Approval date [1] 315140 0
27/07/2020
Ethics approval number [1] 315140 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80458 0
Prof XX
Address 80458 0
XX
Country 80458 0
New Zealand
Phone 80458 0
+64 9 4140800 43657
Fax 80458 0
XX
Email 80458 0
[email protected]
Contact person for public queries
Name 80459 0
XX
Address 80459 0
XX
Country 80459 0
Australia
Phone 80459 0
+64 9 4140800
Fax 80459 0
XX
Email 80459 0
[email protected]
Contact person for scientific queries
Name 80460 0
XX
Address 80460 0
XX
Country 80460 0
Australia
Phone 80460 0
+64 9 4140800
Fax 80460 0
Email 80460 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone

• Researchers

• test 'other' text 1

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol

• test 'other' text 2

What individual participant data will be or are expected to be shared?
• De-identified Individual participant data for:
• Primary outcome(s)
• Safety data
• Individual participant data not covered above: test 'other' text 4

What types of analyses could be conducted using the individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
• test 'other' text 5

When might the individual participant data become available to request access, and for how long?
From:
test 'other' text 6

To:
test 'other' text 7

Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: data repository test

• Data sharing request system: data sharing request system text

• Journal publication or its supplementary materials: journal pub text

• Email of trial custodian, sponsor or committee: email text

• Postal Address: postal address text

• test 'other' text 8

Are there additional conditions or steps involved in requesting or accessing individual participant data?
Yes: test 'other' text 9

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?




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.