Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease

Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease. A Cross-sectional Multi-centre Clinical Study in Subjects With Cardiovascular Disease Risk Factors.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928629

Acronym

ACHILLES

Enrollment

1000

Registered

2009-06-26

Start date

2009-06-30

Completion date

2009-10-31

Last updated

2009-11-13

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

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease, Cardiovascular Disease, Vascular Disease

Brief summary

The primary objective of the study is to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index of less than or equal to 0.9, in subjects with at least two of the specified cardiovascular disease (CVD) risk factors, with no overt cardiovascular disease.

Interventions

PROCEDUREAnkle-brachial index (ABI) Screening Test

Patients will undergo an ABI measurement

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males aged 45 years or above or females aged 55 years or above (age related CVD risk factor). * At least two other risk factors for CVD: cigarette smoking, diabetes mellitus, hypertension, low HDL or high LDL cholesterol, strong family history of coronary heart disease, elevated waist circumference, Aboriginal and/or Torres Strait Islander. * Willingness to participate in study and sufficient command of the English language to read and complete study questionnaire.

Exclusion criteria

* Less than 2 risk factors for CVD (other than age), symptoms of PAD, coronary heart disease or coronary heart disease risk equivalents * No lipid data collected in the last 12 months * Serious or unstable medical or psychological conditions that, in the opinion of the Investigator, would compromise safety or successful participation in the study.

Design outcomes

Primary

Measure	Time frame
Prevalence of lower extremity peripheral arterial disease, defined as an ankle-brachial index of < or = 0.9 in subjects with at least two of the specified CVD risk factors, with no overt cardiovascular disease	1 visit

Secondary

Measure	Time frame
Prevalence of cardiovascular risk factors in the target population	1 visit
Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study	1 visit
Subject characteristics that are determinants of PAD diagnosis	1 visit

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026