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NCT00928629 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— ACHILLES  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00928629
Other study ID # D3560L00089
Secondary ID
Status Completed
Phase N/A
First received June 23, 2009
Last updated November 11, 2009
Start date June 2009
Est. completion date October 2009

Study information
Verified date November 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Procedure:
• Ankle-brachial index (ABI) Screening Test
Patients will undergo an ABI measurement

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

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca Pretium Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Prevalence of cardiovascular risk factors in the target population 1 visit No
Secondary Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study 1 visit No
Secondary Subject characteristics that are determinants of PAD diagnosis 1 visit No
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