Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001051437p
Ethics application status
Submitted, not yet approved
Date submitted
8/09/2025
Date registered
24/09/2025
Date last updated
24/09/2025
Date data sharing statement initially provided
24/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Predicting Outcomes in Peripheral Artery Disease (PAD) Patients with Intermittent Claudication (pain while walking)
Scientific title
Predicting Mortality, Major adverse cardiovascular and limb event outcomes in Peripheral Artery Disease (PAD) Patients with Intermittent Claudication
Secondary ID [1] 315330 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peripheral artery disease (Intermittent Claudication) 338807 0
Condition category
Condition code
Cardiovascular 335101 335101 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will examine a specific smoking-related DNA methylation marker (cg05575921) as an outcome (MACE, MALE, changes in walking impairment, and mortality) risk prediction tool in PAD patients presenting with intermittent claudication.
The duration of baseline recruitment will be December 2025- December 2027.
Participants will complete questionnaires (walking impairment and health demographics) and provide a blood sample for DNA analysis (measurement of cg05575921 DNA methylation level) at study entry (baseline visit of 4o minutes duration),
Follow-up walking distance questionnaires (15 minutes) will be completed by return mail (with telephone support if needed) at 18 months and 5 years post-study entry.
Intervention code [1] 331930 0
Diagnosis / Prognosis
Comparator / control treatment
No control group, prospective outcome study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342735 0
Mortality
Timepoint [1] 342735 0
Recorded at 1.5 and 5 years after recruitment date
Primary outcome [2] 342736 0
Major adverse cardiovascular events (MACE) as a composite outcome of Myocardial infarction, Hospitalisation for unstable angina, Heart failure hospitalisation, Stroke, Unplanned revascularisation, cardiovascular death.
Timepoint [2] 342736 0
Recorded at 1.5 and 5 years after recruitment date
Primary outcome [3] 342737 0
Major adverse limb events (MALE) as a composite outcome of Major amputation, Revascularization, Progression to critical limb ischemia.
Timepoint [3] 342737 0
Recorded at 1.5 and 5 years after recruitment date
Secondary outcome [1] 451952 0
Walking impairment
Timepoint [1] 451952 0
Recorded at 1.5 and 5 years after recruitment date (compared to baseline assessment)

Eligibility
Key inclusion criteria
• Diagnosed with PAD (intermittent claudication).
• Able to consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclude ankle brachial pressure index (ABPI) <0.5 or critical limb ischaemia.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 27343 0
New Zealand
State/province [1] 27343 0

Funding & Sponsors
Funding source category [1] 319910 0
Government body
Name [1] 319910 0
Health Research Council of New Zealand
Country [1] 319910 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 322437 0
None
Name [1] 322437 0
Address [1] 322437 0
Country [1] 322437 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318454 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 318454 0
Ethics committee country [1] 318454 0
New Zealand
Date submitted for ethics approval [1] 318454 0
08/09/2025
Approval date [1] 318454 0
Ethics approval number [1] 318454 0

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

Contacts
Principal investigator
Name 144250 0
Prof Greg Jones
Address 144250 0
Department of Surgery & Critical Care (DSM), University of Otago, PO Box 56, Dunedin 9054
Country 144250 0
New Zealand
Phone 144250 0
+64 3 4709543
Fax 144250 0
Email 144250 0
[email protected]
Contact person for public queries
Name 144251 0
Prof Greg Jones
Address 144251 0
Department of Surgery & Critical Care (DSM), University of Otago, PO Box 56, Dunedin 9054
Country 144251 0
New Zealand
Phone 144251 0
+64 4709543
Fax 144251 0
Email 144251 0
[email protected]
Contact person for scientific queries
Name 144252 0
Greg Jones
Address 144252 0
Department of Surgery & Critical Care (DSM), University of Otago, PO Box 56, Dunedin 9054
Country 144252 0
New Zealand
Phone 144252 0
+64 3 4709543
Fax 144252 0
Email 144252 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.