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

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.

Official Title

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.

Conditions

• Peripheral arterial disease

Study Type

Interventional

Study Design

Screening, Open Label, Single Group Assignment

Further Details

Primary outcome measures 

• Prevalence of lower extremity peripheral arterial disease, defined as an ankle-brachial index of ≤ 0.9 in subjects with at least two of the specified CVD risk factors, with no overt cardiovascular disease
  [ Time Frame: 1 visit ]
  [ Designated as safety issue: No ]

Secondary outcome measures 

• Prevalence of cardiovascular risk factors in the target population
  [ Time Frame: 1 visit ]
  [ Designated as safety issue: No ]
• Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
  [ Time Frame: 1 visit ]
  [ Designated as safety issue: No ]
• Subject characteristics that are determinants of PAD diagnosis
  [ Time Frame: 1 visit ]
  [ Designated as safety issue: No ]

Study Start

June 2009- November 2009

Eligibility & Criteria

• Ages eligible for study: 45 years and older
• Genders eligible for study: Both
• Accepts healthy volunteers: No

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.

Total Enrolment

1000

Contact Details

AstraZeneca Australia Clinical Study Information
1800 805 342
MedOps.Australia@AstraZeneca.com