Peripheral Arterial Disease Clinical Trial
— ACHILLESOfficial 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.
Verified date | November 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
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.
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Pretium Pty Ltd |
Australia,
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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