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

AstraZeneca

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Procedure: Ankle-brachial index (ABI) Screening Test

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00928629

D3560L00089

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

All Subjects

Other group

Description:

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.

Treatment:

Procedure: Ankle-brachial index (ABI) Screening Test