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

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.

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Ankle-brachial index (ABI) Screening Test

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Edgecliff, New South Wales, Australia
      • Research Site
    • Hinchinbrook, New South Wales, Australia
      • Research Site
    • Kingsford, New South Wales, Australia
      • Research Site
    • Kingswood, New South Wales, Australia
      • Research Site
    • Liverpool, New South Wales, Australia
      • Research Site
    • Mosman, New South Wales, Australia
      • Research Site
    • Neutral Bay, New South Wales, Australia
      • Research Site
    • Sydney, New South Wales, Australia
      • Research Site
  • Queensland
    • Aspley, Queensland, Australia
      • Research Site
    • Morayfield, Queensland, Australia
      • Research Site
    • Parkwood, Queensland, Australia
      • Research Site
  • South Australia
    • Beulah Park, South Australia, Australia
      • Research Site
    • Glenelg East, South Australia, Australia
      • Research Site
    • Surrey Downs, South Australia, Australia
      • Research Site
  • Tasmania
    • Bridgewater, Tasmania, Australia
      • Research Site
    • Kingston, Tasmania, Australia
      • Research Site
    • Sandy Bay, Tasmania, Australia
      • Research Site
  • Victoria
    • Brighton, Victoria, Australia
      • Research Site
    • Lalor, Victoria, Australia
      • Research Site
    • Preston, Victoria, Australia
      • Research Site
  • Western Australia
    • Booragoon, Western Australia, Australia
      • Research Site
    • East Victoria Park, Western Australia, Australia
      • Research Site
    • Woodvale, Western Australia, Australia
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All Subjects; ABI Screening Test Population: Subjects of either sex, any race, with at least two of the specified CVD risk factors, with no overt cardiovascular disease.	Procedure: Ankle-brachial index (ABI) Screening Test; Patients will undergo an ABI measurement

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Pretium Pty Ltd
• Investigators: Study Director: Simon Fisher, AstraZeneca; Study Director: Amelia Siu, AstraZeneca; Principal Investigator: David Sullivan, Central Clinical School, The University of Sydney, Sydney, Australia

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 23, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Estimate): November 13, 2009
• Last Update Submitted That Met QC Criteria: November 11, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Vascular Disease; Peripheral Arterial Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: D3560L00089