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Completed

NCT Number: NCT00928629

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Site, Edgecliff, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ankle-brachial index (ABI) Screening Test

Procedure

Patients will undergo an ABI measurement

Primary outcomes

  1. 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

    Time frame: 1 visit

Secondary outcomes

  1. Prevalence of cardiovascular risk factors in the target population

    Time frame: 1 visit

  2. Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study

    Time frame: 1 visit

  3. Subject characteristics that are determinants of PAD diagnosis

    Time frame: 1 visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Pretium Pty Ltd

Registry information

Official study 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.

Acronym: ACHILLES

Important dates

Study start
2009
Study completion
2009
First posted
Jun 26, 2009
Registry last updated
Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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