Predicting Outcomes in Peripheral Artery Disease (PAD) Patients with Intermittent Claudication (pain while walking)

Predicting Mortality, Major adverse cardiovascular and limb event outcomes in Peripheral Artery Disease (PAD) Patients with Intermittent Claudication

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12625001051437

Enrollment

400

Registered

2025-09-24

Start date

2025-11-03

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

None listed

Brief summary

Peripheral artery disease (PAD) is a common circulatory problem in which narrowed arteries reduce blood flow to the limbs. Intermittent claudication (pain while walking) is the main symptom of early-stage PAD. Smoking is a major risk factor, but self-reported smoking history can be unreliable. DNA methylation (DNAm) at the cg05575921 site in the AHRR gene can be measured in blood and is a validated biomarker of smoking exposure. This study aims to assess whether baseline smoking-related (cg05575921) DNAm values can predict future outcomes in PAD patients with intermittent claudication, such as death, surgery, limb loss, and walking ability. We will recruit 400 patients referred to vascular clinics at Waikato, Christchurch, and Dunedin hospitals. At least 30% of participants will be Maori, with prioritised invitations. Participants will provide a blood sample and complete a PAD-specific questionnaire at baseline and 18-month follow-up. DNA will be analysed for methylation at cg05575921 using a droplet digital PCR assay. Clinical outcomes will be followed up via hospital records and the National Minimum Dataset (NMDS).

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Diagnosed with PAD (intermittent claudication). • Able to consent.

Exclusion criteria

Exclude ankle brachial pressure index (ABPI) <0.5 or critical limb ischaemia.

Outcome results